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REGULATORY LANDSCAPE

Home REGULATORY LANDSCAPE Page 3

by EOS Intelligence EOS Intelligence No Comments

K-Beauty: A Trending Obsession Losing Its Novelty but Not without a Fight

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South Korea is the 9th largest cosmetic market globally with a market size of nearly US$ 12.6 billion. Innovative and affordable products made using exotic natural ingredients that focus on enhancing skin health and prevent skin concerns drive the success of K-beauty brands. Moreover, the launch of the first global customized cosmetics regulatory guidelines, along with support from the government to enhance R&D capabilities and to improve infrastructure, seem to reinforce further stability to the already growing sector. However, rising trends such as minimalism and concerns about sustainability might pose a challenge for the Korean beauty brands that thrive on the tenets of long product lines, multiple products pushed on a daily basis, and focus on packaging that tend to use plastic.

K-beauty brands are uniquely well-known due to the use of natural and unusual ingredients such as snail mucin, bee venom, ginseng, pearl, mushrooms, carrot seed oil, royal honey, and yuzu, among others, in their skincare and beauty products. Products incorporated with such ingredients may, at first, sound too out of the ordinary to be a part of one’s beauty regime but they are believed to be effective.

Korea’s beauty and cosmetic sector backed by strong government support

Korean domestic cosmetics industry, which offers growth prospect of more than 5% per year on average, draws huge support from the government. In November 2021, the South Korean Ministry of Health and Welfare declared plans for 2022 to support the cosmetics industry through technology development, preparation of legal system, overseas expansion, and professional manpower training.

On the technology side, the government is focusing on developing a ‘skin genome data platform’ that can collect and utilize skin characteristics and genomic information by country and race. The government will also continue to make mid-to-long term R&D investments towards development of local and sustainable innovative raw materials.

Additionally, plans are underway to complete the construction of the K-Beauty Comprehensive School and Academy in Osong, North Chungcheong Province, for providing professional and comprehensive training to beauty professionals by 2023; the school is to provide comprehensive consulting and train workforce for the industry’s needs.

Another way the government supports the domestic Korean beauty companies is by offering tax breaks if they have an all-export business model.

With an aim to promote the growth of small and medium-sized enterprises (SMEs) in cosmetics industry in Korea, the South Korean Ministry of Health and Welfare along with Foundation of Korea Cosmetic Industry Institute, launched a pilot concept of ‘K-Beauty Experience and Promotion Center’ in September 2021. The center is a comprehensive exhibition space for domestic SMEs in Seoul, allowing SMEs to promote their innovative cosmetic products that they would otherwise be unable to promote due to lack of funds. This is expected to not only enhance brand awareness among domestic consumers but also to strengthen export competitiveness among foreign tourists visiting Korea as potential customers. A monthly event is to display more than 100 products from 30 companies (selected through monthly application process).

In another initiative to promote the beauty sector, the Seoul Metropolitan Government conducted an online beauty industry branding conference in September 2021. Held under the theme ‘Branding Seoul’s K-beauty Industry’, the conference was attended by domestic and international experts and content creators active in the fields of beauty and tourism. Aiming at expanding the K-beauty industry through the Seoul city brand, which constitutes 45.7% of the country’s domestic cosmetics distributors, plans are underway to develop beauty specific tourism products and tourism courses by partnering with beauty creators and beauty flagship stores.

In September 2022, the government also plans to set up K-Beauty consumer hotspots or zones, a place with several K-beauty shops offering discounted deals on beauty and cosmetic products in areas frequented by tourists.

New initiatives: customized cosmetics regulations and product refills

The South Korean Ministry of Drug and Safety (MFDS), in March 2020, introduced the world’s first regulatory guidelines on custom cosmetics. This will allow manufacturers to provide consumers with cosmetics made on the spot by mixing ingredients based on personal preferences. The regulations came into effect in October 2020 and aim at ensuring that businesses (manufacturers or retailers) comply with safety management standards for the formulation of custom cosmetics.

The authorities also encourage cosmetic companies to offer cosmetic product refill services keeping in mind environmental benefits as well as cost effectiveness. People can purchase refill products at 30% to 50% lower prices when compared to a newly packaged product. As of June 2021, the country had 150 custom cosmetic stores, out of which 10 stores offered refill services where consumers could refill products such as shampoo, conditioner, body wash, and liquid soap. The program will allow consumers to refill products on their own without the need of a customized cosmetics dispensing manager. To make this initiative more effective, a pilot program, which will run for two years, is being conducted wherein existing store staff (who have been trained to work at refill stores) can replace the customized cosmetics dispensing managers.

A customized cosmetics system, wherein certified individuals can mix cosmetics according to a consumer’s individual skin condition and preference at stores, is a revolutionary change in the beauty industry where any concerns related to product usage or suitability can be minimized, if not eliminated completely.

International brands and PE firms investing in Korean beauty brands

Innovation is at the forefront of the Korean beauty industry. A number of consumer goods and international beauty players have invested in innovative Korean beauty brands.

Estée Lauder, a multinational beauty company, acquired Have & Be Co. Ltd., a Korean beauty company, for nearly US$ 1.1 billion in 2019. The deal was made with a key focus on acquiring Dr. Jart+ brand, an innovative high-performing skin care brand, and Do The Right Thing (DTRT) men’s grooming brand.

In October 2021, Glow Recipe, a Korean skincare brand whose products are made with fruit extracts, received an investment from the US-based private equity firm North Castle Partners (for an undisclosed amount). The brand aims at using the investment funds for marketing and global expansion.

Private equity firms are also investing in local brands based in Korea. Helios Investment Partners, a London-based emerging markets-focused private equity firm, signed a stock purchase agreement (SPA) in October 2021, to acquire management rights with a 67% stake in Soleo Cosmetics, a cosmetics and household goods development and production company. The value of the transaction is said to be around US$ 32.5 million. Additionally, in September 2021, JKL Partners, South Korean private equity firm, announced that they will acquire Perenne Bell, a domestic brand that offers organic and sensitive skin products to consumers, and will help the brand focus on entering new markets, including the USA, Japan, and the Middle East.

Not everything is as ideal as it seems

Despite beauty brands claiming their products to be well-researched, organic, and environment friendly, issues exist. In early 2021, sunscreens from Korean brands such as Purito, Dear Klairs, and Keep Cool were under scrutiny when, on the basis of independent lab tests, it was found out that their sunscreens have far lower SPF that what was indicated on the packaging. Following the controversy, the brands withdrew their sunscreen products from the international markets and issued refunds to the customers.

In another incident, Innisfree, a cosmetic brand owned by Korean firm AmorePacific, was called out for misrepresenting the product’s eco-friendly credentials – on the packaging, the product was wrongly labelled as “paper bottle” whereas it actually came in a plastic bottle wrapped in paper.

Loyalty and trust are important in the beauty business and while it might be incorrect to write-off all Korean beauty brands based on a few bad incidents, consumers would not shy away from exploring other brands that offer what they claim.

EOS Perspective

Over the years, South Korea’s cosmetics industry has built a stronger position on the global map especially with the use of innovative and natural ingredients, and a shorter product development cycle. The quality of Korean beauty products, sold with a promise of flawless and crystal-clear skin, is the biggest selling point in a hyper-competitive beauty market.

The popularity of Korean skincare brands is definitely growing but it is not just driven by innovation or quality but also propelled by the mounting fascination for everything Korean, be it culture, entertainment, food, or beauty. Right now, the charm of Korean wave is so prominent that anything Korean will sell and Korean beauty brands are leveraging this opportunity to make big bucks. However, they might not to be able to ride the tide forever.

Since COVID-19, beauty industry has undergone momentous changes. As lifestyles changed and staying indoors and wearing masks became the new normal, the demand for make-up products decreased and the need for skincare products increased. The trend is here to stay. People want healthier skin but prefer to achieve it through easier, minimal, and effective skincare routines and K-beauty brands might be popular for a lot of things but minimalism. By updating their product lines with the strangest of ingredients, discontinuing products, and asserting the use of multiple products on a daily basis, Korean beauty brands tend to over-tire the consumers. Rising trends such as skinalism that focuses on single multi-functional products and sustainable packaging that demote the use of plastic pose further challenge for Korean beauty brands.

In the ever-changing beauty industry, beauty regimes change rapidly and country-led beauty regimes are no exception. With new beauty trends and regimes such as J-beauty and C-beauty quickly catching up among consumers, the novelty of K-beauty products will definitely wear off sooner or later.

K-beauty can perhaps be considered just a fad that stayed and resonated with consumers for more than a decade. For now, the appeal of this trend is not expected to fade very soon. As for the time when the ‘all things Korea’ fascination is over, only players who have been able to build their brand awareness and gain consumers’ trust are likely to successfully continue when the Korean tag will no longer be a pass for high sales.

by EOS Intelligence EOS Intelligence No Comments

Morocco’s Auto Industry Is in Full Gear

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Over the past few years, Morocco has established itself as a leading manufacturing hub for automobiles in Africa, surpassing South Africa as the biggest exporter of passenger cars on the continent. The North African country is well-placed geographically as well as economically (thanks to the African Continent Free Trade Agreement) to export cars to European markets, especially France, Spain, Germany, and Italy. While the market continues to grow and gain importance among auto manufacturers, it is to be seen if it can disrupt Asian auto manufacturing hubs in the future.

With the capacity to produce over 700,000 vehicles per year and employing about 220,000 people in the sector, Morocco has gained mass appeal as a leading automotive manufacturing hub in the African region. Several international auto manufacturers, such as Renault, Peugeot, and Volkswagen have set up units in Morocco and have been growing their exports from the market. The Moroccan government signed 25 separate trade agreements with several auto and auto parts manufacturers across the EU and the USA and this is estimated to drive the Moroccan automobile market to be worth US$22 billion by 2026. Moreover, the government has stated that it wants to reach a production capacity of 1 million vehicles by 2025.

Investments

Several companies have established presence in Morocco as a cost-effective gateway to the European markets, the largest of them in terms of production numbers being Renault. Renault was the first global auto manufacturer to enter Morocco in 2012 and has plants in Tangier and Somaca (Casablanca). The plants have a respective capacity of about 400,000 vehicles and 85,000 vehicles annually. The automaker has already exported more than 1 million vehicles from its Morocco plants and has further signed agreements with the Moroccan government to expand auto production in the country.

French automaker Peugeot (Group PSA) is another major automobile manufacturer in this country. In 2019, Peugeot opened a US$600 million plant in Kenitra, north of Rabat, which produces the Peugeot 208 at a capacity of 200,000 vehicles annually.

Other carmakers operating in Morocco include Volkswagen, which shut down its plant in Algeria in 2019 and moved it to Morocco. In a similar move, in 2021, Korean automobile giant, Hyundai, decided to suspend its production in Algeria and move it to Morocco, cementing Morocco’s position as the go-to manufacturing hub for automobiles in North Africa.

In addition to the presence of several leading car manufacturers, the country also houses a large number of parts manufacturers and has successfully leveraged backward integration. An American player, Lear, operates 11 production sites here for the production of automotive seating and electrical systems. Similarly, Chinese aluminum automotive parts manufacturer, Citic Dicastal, set up two plants in the Kentira region for the production of six million aluminum rims annually that it aims to supply to the Peugeot plant. In addition, auto part companies such as France-based Valeo, US-based Varroc Lighting Systems, and Japan-based Yazaki and Sumitomo also established presence in Morocco.

Morocco’s Auto Industry Is in Full Gear by EOS Intelligence

Apart from large international parts manufacturers, the country also houses several local players that support and provide parts to the automobile giants. The government has been promoting partnering with local suppliers to provide a boost to the domestic industry. In 2021, Morocco’s leading automobile manufacturer, Renault, entered into a strategic agreement with the government to increase local sourcing to US$2.9 billion by 2025 (from 2023 forecast of US$1.7 billion) and increase local integration to 80%, up from 2023 forecast of 65%.

While Morocco continues to cement its place as a leading auto manufacturing hub in Africa, it is simultaneously aiming to position itself as a preferred hub for EV and EV component production. In 2017, the government signed a deal with a Chinese electric automobile manufacturer, BYD Auto, to build a new plant in the Tangier region. The plant will be spread over 50-hectare and will employ about 2,500 personnel. However, its opening is facing delays and no date of completion has been announced yet.

In October 2021, a leading EV manufacturer, Tesla, deployed its first two supercharger stations in Morocco, marking its first foray into the African continent. While the EV giant has not announced its formal entry to the market yet, usually deploying supercharging stations and service centers has been its first step in entering a market.

In addition to this, in 2021, STMicroelectronics, an EV chip producer announced that it was set to open a new Tesla-dedicated EV chip production line at its facility in Bouskoura, Morocco, following a win of a contract with Tesla. Following this, STMicroelectronics also signed a strategic cooperation agreement with Renault to supply electric and hybrid vehicle advanced semiconductors for Renault’s Dacia Spring EVs range, starting 2026. While currently the Dacia Spring EV model is produced in China, chip production in Morocco raises prospects of the current electric model or any future models to be manufactured in Morocco, especially for the European market. This places Morocco in a strategic position to also become a leader in EV manufacturing in the African subcontinent.

Government initiative

While Morocco has a strong geographic advantage, given its proximity to several European countries that makes it an ideal export market, political stability is another factor contributing to the sectors growth. The Moroccan government offers a single window outlet at its Ministry of Industry and Trade, which makes it much easier for international players to do business as compared with other countries that are more bureaucratic and complex in their dealings. Moreover, the government is known to be consistent with their policies, which is critical for auto manufacturers looking to make long term investments.

The government has made tremendous efforts and investments in developing Morocco into a global auto manufacturing hub. Morocco has about 60 free trade agreements with Europe, the USA, Turkey, and the UAE, a fact that facilitates easy trade and exports.

In addition, the Moroccan government provides several tax benefits to companies setting up manufacturing units in the country. It offers zero tax for the first five years and 15% tax for the subsequent years. Moreover, it provides full exemption on value added tax and a 15-year exemption on business and occupation tax.

Apart from fiscal benefits, it has also constantly invested in infrastructure to ensure smooth operations with regards to both manufacturing and transportation. In 2015, the government allocated US$7.8 billion towards development of infrastructure including roads, airports, etc.

Moreover, in 2018, the government inaugurated the US$4 billion Al-Boraq high-speed rail line linking the two key auto manufacturing hubs, Casablanca and Tangier. The Al-Boraq line is also linked to the Tanger Med port, which is a key port for all exports to Europe. The Tanger Med port has also become the largest port in the Mediterranean region post its phase II development in 2019. The port now has a capacity of 9 million twenty-foot equivalent units, surpassing Spain’s Algeciras and Valencia ports in capacity. The development and expansion of the rail link and the ports have facilitated smooth export from Moroccan manufacturing plants to European markets.

Furthermore, the government also facilitates staff training through the creation of the Automotive Industry Training Institutes (Instituts de Formation aux Métiers de l’Industrie Automobile (IFMIA)). The training support centers address recruiting and competency development needs of companies operating in the sector. While three of the centers are managed by the Moroccan Automotive Industry and Trade Association (AMICA) at Casablanca, Kenitra, and Tangiers, the fourth center is run by Renault and is located at Renault’s Mellousa plant. The Moroccan government provided about US$10 million for the construction of the Renault training center, which has more than 5,000 students (about 4,200 of them work for Renault). This way the government provides comprehensive and all-encompassing support to the sector, which in turn is expected to permeate to the development of the local vendors and suppliers as well.

Other than this, Morocco enjoys the obvious advantage of low cost labor (although this is something common to the entire African region). The cost of labor in Morocco is about US$1.5 per hour, which is about one-fourth of that in Spain and much lower than many East European nations. Since companies such as Renault produce their entry level cars in Morocco, labor constitutes a high portion of the overall costs.

EOS Perspective

With strong political support, advantageous geographical location, and low labor costs, Morocco seems to have all the right ingredients for a booming auto industry. The sector has been witnessing exponential growth over the past few years and has already overtaken South Africa as the largest automobile manufacturer in Africa.

While the industry currently caters to the manufacturing of low cost models, it is also slowly creating a niche space for itself in the EV market, which is considered the future of the automobile sector. Moreover, the sector is creating an entire automobile ecosystem by encouraging and promoting backward integration, especially through the participation of local auto part suppliers and vendors.

There is clearly no contention that the North Africa is the leader in the automobile space in the region, however, it is still a long way before the region is a serious competitor in the global auto export market to countries such as China, India, Korea, or Mexico, which are global leaders. A lot will depend on how it manages to develop competencies beyond cheap labor and supportive policies, especially with regards to attracting premium and luxury models. While it has the potential, it will be difficult to displace leading hubs that are already competent in the space.

Clean Beauty Next Stop China by EOS Intelligence
by EOS Intelligence EOS Intelligence No Comments

Clean Beauty: Next Stop – China

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China is one of the most promising markets for cosmetics and skin care companies globally, only being second to the USA in size. Despite its size and potential, the Chinese beauty market has remained relatively closed to several international players that make cruelty-free and vegan products. This is because of Chinese regulations that required compulsory animal testing pre- and post-market entry for international brands. However, in 2021, the Chinese government squashed the mandated animal testing requirement and introduced other certification methods. While this opens the market for a plethora of players who have till now shied away from entering the Chinese market, steering through the Chinese turf may still not be very simple.

China’s new cosmetic regulations easing entry for imported products

China is currently the second-largest cosmetics market globally, and has an immense potential to grow further. As per China’s Ministry of Commerce, the value of imported cosmetics grew by 30% in 2020, underlining the strong potential for international brands in the Chinese market. At the same time, several international companies have kept their distance from this US$57 billion beauty and personal care market, owing to stringent regulations.

However, in 2021, the government introduced new rulings for cosmetics and beauty products, which have altered the regulatory landscape in China. As per Chinese regulations, cosmetics are divided into two categories, special and general cosmetics, and the two are subject to different pre-market registration requirements.

As per the new regulations, while the former will continue to be subject to pre-registration with National Medical Products Administration (NMPA) before being allowed to be manufactured or imported, general cosmetics now only require filing documentation of the product with the authority. Earlier, the general category also required prior approval before import.

In addition to streamlining the process for the general category, the government has reduced the number of special product categories from nine to six. As of 2021, the only product categories under the special category encompass hair dye products, hair perm products, spots removal and skin whitening products, sunscreen products, and hair loss prevention products. The streamlining of the registration process for general category is expected to have a direct impact on the cost of warehousing and logistics for global brands as it is likely to quicken the import cycle.

Another regulation that was a deterrent to entering the Chinese market was that international beauty companies were expected to perform animal testing for their products both pre-and post-market entry. This created an issue for the growing number of global clean beauty brands who position themselves as vegan or cruelty-free. These brands could either choose to dilute their brand positioning by undertaking animal testing for the Chinese region or had to keep away from this goldmine market.

However, these companies did have one channel to enter this market, and that was through cross-border e-commerce sites, such as Alibaba’s Tmall. Although this resulted in a limited presence as the cross-border market size has government restrictions and is about one-tenth the size of the domestic market. Moreover, physical retail still continues to dominate the Chinese market with regards to cosmetics sale, with growing popularity of multi-brand stores.

As per the new regulations, global companies do not require animal testing anymore before entering the Chinese market. This will level the playing field between international imports and domestic brands, as domestic brands have been exempt from animal testing since 2014.

However, there are a few conditions to be met by companies looking to bypass animal testing. The brand must provide relevant quality certifications from their country of origin, the product should not be aimed at children or babies, the product should not contain any raw material that is not included in China’s approved list of raw materials, and the applicant brand and its Chinese representative should not have been flagged as requiring further supervision by the authorities.

Clean Beauty Next Stop China by EOS Intelligence

Companies responding to the new regulations

This opens the door for several international players who position themselves as cruelty-free. In May 2021, Australian clean beauty brand, Frank Body, welcomed a closed investment from Chinese private equity firm, EverYi Capital, which put the value of the brand at about US$74 million (AUD 100 million). The investment, which includes the creation of a Shanghai team for the brand, will help the company find a strong footing in the Chinese market in the light of the latest animal testing relaxation. The brand is expected to enter the market over the next 12 to 18 months, with prospects of opening a physical store.

In a similar move, Brazilian beauty conglomerate, Natura & Co., mentioned during its 2020 fiscal year results that it is looking to expand into China with its brands, Aesop and The Body Shop. The two brands were expected to complete their registration in China by first half of 2021, with Aesop expected to open its first store in Shanghai by the end of 2021, while The Body Shop is scheduled to open its first store in 2022 (however, there is no information regarding the completion of the registration process yet). While these brands have been available in China through cross-border e-commerce, they expect that physical retail presence will help establish a strong foothold in this growing market.

Nerissa Low, founder of Singapore-based organic and cruelty-free cosmetic company, Liht Organics, has also welcomed the decision and expressed interest in entering the offline Chinese market. Liht Organics, which entered China in 2020 through cross-border e-commerce, gained significant traction in the Chinese market. However, the brand refused to enter the offline market when approached by several Chinese distributors, as the company did not want to compromise on its cruelty-free ethos. Given the change in regulations, the founder has expressed interest in expanding beyond cross-border e-commerce considering the potential in the offline market and is looking for the right partner and opportunity.

Moreover, popular international brands such as Drunk Elephant, Fenty Beauty, and The Ordinary, which are currently limited to be selling through Alibaba Tmall, are expected to enter the Chinese market and establish a physical presence there. While a lot of these brands might wait to establish physical stores and may penetrate the market through mainland e-commerce websites such as Tmall (instead of Tmall Global) to reach a larger audience, presence in multi-brand retail stores or opening pop-up stores will be the natural next step.

Despite new regulations, challenges remain

However, entering the Chinese market (despite the abolishment of the animal testing rules) will be no easy feat. Owing to the recent changes in regulations, the companies need to keep up higher standards in terms of product quality, marketing, and operations. Moreover, some of these regulations have made it harder for foreign players to comply as they require a complete overhaul of their local marketing strategies and operational functions.

Firstly, as per the new regulations, the NMPA of China has made it mandatory for international companies to have a domestic agent who must be based in China. This agent will be responsible for the registration process, which includes massive paperwork and approval procedures. Moreover, these agents will be held completely accountable for the company’s products and operations in China and will be answerable and responsible for any safety concerns arising in the product. In addition, they will be responsible for ensuring that the product, its ingredients, and its marketing are compliant with the Chinese regulations. Thus it will be a challenge for foreign players to find a Chinese agent to fill this capacity as in reality, such a person/company may have no impact on how the ingredients or final product are made. This is also definitely expected to increase costs for the company.

The government has also imposed harsher penalties for non-compliance and various violations such as misleading advertising, non-compliance of new cosmetic naming guidelines, non-submission of approved hygiene license and certificates, etc. This makes it critical for companies that the Chinese agent is well aware of all regulations and is thorough with all registration requirements as violations can also result in cancellation of license.

Secondly, while the removal of animal testing for imported cosmetics is a welcome news for a great number of global cosmetic brands, the policies put in place of this pose to be equally challenging and complex to steer through. Under the new regulations, cosmetics falling under the general category require a Good Manufacturing Practice (GMP) certificate to avoid animal testing. These GMP certificates need to be issued from the brand’s local government regulatory department. Considering that different countries will have different authorities and templates for issuing these certificates, there is a lot of ambiguity regarding what is acceptable and what is not.

Moreover, cosmetic companies need to provide a manufacturing quality management system (QMS) for each individual ingredient used in the cosmetic formulations. This requires companies to collect information on each and every ingredient manufacturer and supplier, including their quality specification documents and certificates. This is a tedious process since a company may use ingredients from several manufacturers for a single product. In addition, in case a company plans to change a supplier, it will have to undergo this process and update the information with the Chinese authorities for the new supplier, which is both money and time consuming.

On the one hand, it is true that the exemption from animal testing has given an opportunity of many cruelty-free brands to enter the Chinese market. However, on the other hand, the lengthy procedure and strict scrutiny over the process is undermining the overall market entry process for mid to small size companies. Non-compliance with these certifications will reverse the relaxation on animal testing for the companies that don’t meet the new procedural requirements and then their products will need to undergo animal testing for selling in China.

Furthermore, despite getting the green light to enter the Chinese market, the cruelty-free cosmetic companies would still need to deal with another challenge arising from the consumer side. While the clean beauty segment is definitely growing, it is currently not a major factor in purchasing decisions by consumers, unlike in the USA. Chinese consumers seek products that are functional and have healthier, milder, and more reliable formulas. Hence, to ensure a right placement of their cruelty-free products, companies would need to undergo distinctive marketing strategies to grab a good consumer base. Education and awareness regarding cruelty-free products and creating a substantial market for such products may require significant marketing funds.

In addition to the changes in regulations with regards to animal testing, the Chinese government added new regulations regarding product labelling. As per the new regulations, the labels must have corresponding Chinese explanation to everything mentioned and they must a have larger font size than the explanation in foreign language. Also, the label should contain the Chinese name and special cosmetics registration certificate numbers, product implementation number, name and address of the person responsible in China and of the manufacturer along with the production license number.

Adding to these is a ban on use of any kind of medical term, names/pictures/endorsement of celebrities in the medical field, and implication of medical effects to avoid any misleading of information. Although all these changes are implemented in order to curb the market of counterfeit products, they are expected to make the product approval process lengthier, as now companies would be required to undergo a comprehensive regulatory review of the guidelines to ensure hassle-free entry into the Chinese market.

EOS Perspective

While the new regulations provided a pathway for several foreign clean beauty players to enter the Chinese market, the process still requires a lot of navigation, especially since a lot of rulings regarding safety requirements, GMP authorities, and template remain ambiguous.

Moreover, since these certificates need to be derived from the country of origin, the country’s overall political and business equation with China might also play a subtle role in their acceptance by the Chinese authorities. For instance, China has not yet declared the jurisdictions that will be recognized for the QMS certificate. Given the current political friction with Australia and the USA, the Chinese authorities may not accept QMS certificates from these countries at the moment. Thus brands from these countries may have to look to find suppliers or shift part production to other countries to be able to enter the Chinese market.

While currently there is no clarity regarding what terms and jurisdictions will initially be accepted for the GMP and QMS certificates, it is expected that clarity on the matter will be provided by the government shortly. In the long run, these regulations are a move in the right direction. As the government has overall simplified the filing process and focused on quality and safety measures, the new regulations are a positive development for international cosmetic companies, especially clean beauty brands that have been unable to enter the second largest beauty market in the world.

UK Paves The Way for A Greener and Carbon-Free Future
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UK Paves The Way for A Greener and Carbon-Free Future

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The UK is working to create a policy for building a more sustainable future for itself through the New Green Industrial Revolution, aiming to attain net-zero emissions in the UK by 2050. As the country separated itself from the EU through Brexit, it is also setting its own environmental goals and in that, its own version of the EU’s 2019 Green Deal (we wrote about it in The EU Green Deal – Good on Paper but Is That Enough? in March 2020). With highly ambitious targets, the proposed investments are worth GBP12 billion, creating 250,000 jobs in the process. While this seems like a promising funds allocation, the plan’s success will actually depend on significant investments in next-generation technologies, which have currently not been proven commercially. Moreover, a lot will depend on an equal involvement from the private sector that might be more cautious with investments than the public sector.

The UK is in a bid to position itself at the forefront of global markets for green energy and clean technologies. To achieve this, it proposed a 10-point Green Industrial Revolution in November 2020, which aims to mobilize GBP12 billion funds and create 250,000 jobs in the UK. Through this plan, the UK aims to achieve net zero carbon emissions by 2050. The key areas covered under the plan include offshore wind, hydrogen, nuclear, electric vehicles, public transport, jet zero and greener maritime, homes and public buildings, carbon capture, nature, and innovation and finance.

UK Paves The Way for A Greener and Carbon-Free Future

Offshore wind

The new Green Industrial Revolution outlines the UK government’s commitment to put offshore wind energy at the forefront of the country’s electricity needs. It has increased the offshore wind targets from previous 30GW to 40GW by 2030, aiming to produce enough energy to power all homes in the UK by 2030.

In addition to this, the government plans investments of about GBP160 million to upgrade ports and infrastructure in localities that will accommodate future offshore wind projects (e.g. Teesside, Humber, Scotland, and Wales).

This investment in developing offshore wind energy is expected to support about 60,000 direct and indirect jobs by 2030 in construction and maintenance of sites, ports, factories, etc.

While the government’s plan is great on paper, meeting the 40GW target will require 4GW of offshore wind projects to be commissioned every year between 2025 and 2030, which is extremely ambitious and challenging. Moreover, just developing offshore wind projects will not be enough until works are also done to update the electricity grid. Further, the target 40GW generation is calculated based on current electricity demand by households, which in reality is bound to increase as a shift towards electric vehicles is being encouraged.

Hydrogen

With the help of industry partners, the UK government plans to develop 5GW of low carbon hydrogen production capacity by 2030 for industries, transport, and residences. The government is expected to publish a dedicated Hydrogen Strategy in 2021, to position the UK as a front runner in production and use of clean hydrogen. It plans to develop 1GW (of the planned 5GW) hydrogen production capacity by 2025.

A central part of the UK’s Hydrogen Strategy is expected to have hydrogen potentially replace natural gas for the purpose of heating. The government is undertaking hydrogen heating trials, commencing with building a ‘Hydrogen Neighborhood’ and potentially developing a plan for the first town to be heated completely using hydrogen by 2030.

In addition to this, works with industry partners are under way to develop ‘hydrogen-ready’ appliances in 2021, such that new gas boilers can be readily converted to hydrogen if any future conversion of the gas network is commissioned. To facilitate this, the government is working with Health and Safety Executives to enable 20% hydrogen blending in the gas network by 2023. However, this is subject to successful trials.

In transportation, an investment of GBP20 million in 2021 is planned to test hydrogen and other zero emission freight truck technologies in order to support the industry in developing zero-emission trucks for long-haul road freight.

To achieve these targets, a GBP240 million Net Zero Hydrogen Fund is planned to be set up. It will provide capital co-investment along with the investment from private sector to develop various technologies. These will include carbon capture and storage infrastructure for the production of clean hydrogen that can be used in home, transport, and industrial requirements. The policy is expected to support 8,000 jobs by 2030 and push private investment worth GBP4 billion by 2030.

However, the government’s ambitious 2030 hydrogen policy requires significant investment and participation from the private sector. While several global companies such as ITM Power, Orsted, Phillips 66, etc., have come together to collaborate on the Gigastack project in the UK (which aims to produce clean hydrogen from offshore wind), such private participation will be required on most projects to make them feasible and meet the targets.

Nuclear power

In search of low-carbon electricity sources, UK plans to invest in nuclear energy. In addition to development of large-scale nuclear plants, the investments will also include small modular reactors and advanced modular reactors.

To this effect, the government has set up a GBP385 million Advanced Nuclear Fund. Of this, GBP215 million is to be used towards small modular reactors, i.e., to develop a domestic smaller-scale nuclear power plant technology that could be built in factories and assembled on site. Apart from this, GBP170 million is to be used towards research and development of advanced modular reactors. These are reactors that could operate at over 800˚C, and as a result, unlock efficient production of hydrogen and synthetic fuels. These are also expected to complement the government’s other investments and initiatives with regards to hydrogen and carbon capture.

While the government expects the design and development of small modular reactors to result in private sector investment of up to GBP300 million, these next generation small reactors are currently considered a long shot as no company has created them yet. While Rolls Royce has offered the government to design one, it is conditional on them receiving a subsequent order worth GBP32 billion for 16 such reactors as well as the government paying half of the GBP400 million design cost.

Moreover, nuclear power plants are expensive and long-term investments and are considered to be one of the most expensive sources for power. Thus it is very important to evaluate their economic feasibility. While the government is bullish on the role of nuclear power in decarbonizing electricity, it is very important for large-scale projects to be economical, while small-scale projects still remain at a conceptual stage.

Electric vehicles

It is estimated that cars, vans, and other road transport are the single largest contributor to the UK’s carbon emissions, making up nearly one-fifth of all emissions emitted. Thus the government is committed to reducing carbon emissions produced by automobiles. To achieve this, the country plans to ban the sale of all new petrol and diesel cars and vans by 2030 (10 years earlier than initially planned). However, hybrid cars will be allowed to be sold till 2035.

The government has planned a support package of GBP2.8 billion for the country’s car manufacturing sector, which in turn is expected to create about 40,000 employment opportunities up till 2030. Of this, GBP1 billion will be used towards the electrification of vehicles, including setting up factories to produce EV batteries at scale. In addition to this, GBP1.3 billion is planned to be spent to set up and enhance charging infrastructure in the country by installing a large number of charge points close to residential areas, office and commercial spaces, highways, etc., to make charging as convenient as refueling. The government plans to have a network of 2,500 high-power charging points by 2030 and about 6,000 charging points by 2035. Lastly, grants are planned to the tune of about GBP582 million up till 2023 to reduce the cost of EVs (cars, vans, taxis, and two-wheelers) for the consumer. In addition to the investment by the government, private investment of about GBP3 billion is anticipated to trickle into the sector by 2026.

While this is considered to be a very important step in the right direction, it is estimated that it will still leave about 21 million polluting passenger vehicles on the UK roads by 2030 (in comparison to 31 million in 2020). Moreover, the government continues to allow the sale of hybrid cars for another five years beyond 2030, which means that carbon emissions-producing vehicles will still be added to UK roads even after the target dates set in the New Green Industrial Revolution plan.

Green public transport

In addition to reducing carbon emissions from passenger cars, the government also wants to make public transport more approachable and efficient. It plans to spend about GBP5 billion on public transport buses, cycling- and walking-related initiatives and infrastructure.

In addition, funding of GBP4.2 billion is planned on improving and decarbonizing the cities’ public transport network. This will include electrifying more railway lines, integrating train and bus network through smart ticketing, and introducing bus lanes to speed up the journey. The plans also include investment in about 4,000 new zero-emission buses in 2021, as well as funding two all-electric bus towns (Coventry and Oxford) and a completely zero-emission city center. While York and Oxford have shown interest in becoming the UK’s first zero-emission city center, the government has not yet formally announced the city for the same.

Improvements in public transport networks in other cities are also planned to bring them on par with London’s system. A construction of about 1,000 miles of segregated cycle lanes is in plans to encourage people to take up this mode of transportation for shorter distances.

While it is expected these investments will encourage people to use public transport more, the current COVID pandemic has created apprehensions when considering such shared transportation. Although this is expected to be a short-term challenge, it may be a slight damper to the government’s plan for the next year or so.

Jet zero and green ships

Apart from road transport, the government also aims at decarbonizing air and sea travel. It plans to invest GBP15 million in FlyZero – a study by Aerospace Technology Institute (ATI) aimed at identifying and solving key technical and commercial issues in design and development of a zero-emission aircraft. Such an aircraft is expected to be developed by 2030. In addition to this, the government plans to run a GBP15 million competition for the development of Sustainable Aviation Fuel (SAF) in the UK. The plans also include investing in upgrading airport infrastructure so that it can service battery and hydrogen fueled aircrafts in the future.

In addition to aviation, the government is also investing GBP20 million in the Clean Maritime Demonstration Programme to develop clean maritime technology.

While the plans to develop greener fuel for aircraft and ships is a step in the right direction, it is still somewhat of a long shot as a lot more investment is required into this than proposed. Moreover, the shipping industry in particular has shown little interest in wanting to reform in the past and it is likely that both the sectors will continue to follow international standards (that are high in carbon emissions) to remain competitive globally.

Greener buildings

The UK has a considerable number of old and outdated buildings that the government wants to put in the center of its Green Industrial Plan, thus making existing and new buildings more energy efficient. The plan is to slowly phase out carbon-heavy fossil fuel boilers currently used for heating buildings and instead promote the use of more carbon efficient heat pumps. For new buildings, an energy efficiency standard is to be developed, known as the Future Home Standard. To achieve this, the domestic production of heat pumps needs to be ramped up, so that 600,000 heat pumps are installed annually by 2028. This is expected to support about 50,000 jobs by 2030. In addition to this, the government is providing GBP1 billion to extend the existing Green Home Grant (launched in September 2019) by another year, which is aimed at replacing fossil fuel-based heating in buildings with more energy efficient alternatives.

While the subsequent shift to heat pumps from gas boilers will definitely help reduce the buildings’ carbon footprint, heat pumps are currently much more expensive and more difficult to install. Thus, the government must provide ongoing financial incentives for consumers to make the switch.

Carbon capture, usage, and storage

Carbon capture, usage, and storage (CCUS) technology captures carbon dioxide from power generation, low carbon hydrogen production, and industrial processes, and stores it deep underground, such that it cannot enter the atmosphere. In the UK, it can be stored under the North Sea seabed. A the technology has a critical role to play in making the UK emission free, a GBP1 billion investment is planned to support the establishment of CCUS in 4 industrial clusters by 2030 to capture 10Mt of carbon dioxide per year by 2030. Developed alongside hydrogen, these CCUS will create ‘SuperPlaces’ in areas such as the North East, the Humber, North West, Scotland, and Wales. The development of the CCUS is expected to create 50,000 jobs by 2030.

CCUS is a very new technology, with no large-scale or commercially successful projects operational across the world. While the technology has been proved in pilot projects, its feasibility is yet to be seen. Also, a significant amount of private investment will be required to carry through the proposed project. While some private players, such as Tata Chemicals Europe have begun constructing the first industrial-scale CCU plant (expected to capture 40,000 tons of CO2 per year) in Northwich, the government needs several more private players to step up to meet its ambitious targets.

Nature

In addition to the above mentioned programs, the government plans to safeguard and secure national landscapes as well as restore several wildlife habitats to combat climate change. To achieve that, it plans to reestablish several of the nation’s landscapes under National Parks and Areas of Outstanding Beauty (AONB), as well as create new areas under these two heads. The National Parks and AONB program is expected to add 1.5% of natural land in the UK and will help the government in reaching the target of bringing 30% of the UK’s land under protected status by 2030.

In addition to this, the government plans to invest GBP40 million in nature conservation and restoration projects, which in turn is expected to create several employment opportunities across the country. Moreover, it plans to invest GBP5.2 billion over six years into flood defenses, which will help combat floods and damage to homes as well as natural environment. This is also expected to create about 20,000 jobs up till 2027.

Green finance and innovation

The last agenda on the 10-point Green Industrial Revolution entails developing new sources of financing for supporting innovative green technologies. To this effect, the government has committed an R&D investment of 2.4% of its GDP by 2027. This will extensively be used towards developing high risk, high reward green technologies, which will help the UK attain net zero emissions by 2030.

Additionally, the government launched a GBP1 billion Net Zero Innovation Portfolio that will focus on commercialization of low-carbon technologies mentioned in the 10-point agenda, including development of floating offshore wind, nuclear advanced modular reactors, energy storage, bioenergy, hydrogen, greener buildings, direct air capture and advanced CCUS, industrial fuel switching, and other disruptive technologies. In November 2020, the government launched the first phase of this investment, GBP100 million, towards greenhouse gas removal and in the coming year it plans to invest another GBP100 million towards energy storage. It also plans to invest GBP184 million for fusion energy technologies and developing new fusion facilities. Moreover, GBP20 million will be directed towards development and trials of zero emission heavy goods vehicles.

Apart from this the government plans to issue the UK’s first Sovereign Green Bonds in 2021. These bonds, which are likely to be first of many, are expected to finance sustainable and green projects and facilitate the creation of ‘green jobs’ in the country. Furthermore, similar to the EU Green Deal, the government plans to implement a green taxonomy, which helps define economic activities into two categories – the ones that help limit climate change and others that are detrimental to the environment – to help investors make better investment choices.

EOS Perspective

The UK’s Green Industrial Revolution seems to be a comprehensive policy with a multi-pronged approach to tackle climate change, promote green technology and investments, and achieve net zero emissions by 2050. With Brexit in action, it seems like a worthy counterpart to the EU’s Green Deal, which the UK was initially a part of. Moreover, it is an important framework for the UK to show its commitment towards controlling climate change, especially with the country hosting the upcoming 26th session of the Conference of the Parties (CoP 26) to the United Nations Framework Convention on Climate Change summit in Glasgow in 2021.

However, currently the UK’s Green Industrial Revolution is not a legally binding policy document but more of a proposal, which would need to go through several legislative procedures to become binding. Moreover, while the plan is ambitious, it depends heavily on next generation innovative technologies that require hefty investments to achieve the targets. Thus, its success depends on whether the government is seriously committed and prepared to spend heavily on commercializing these technologies along with managing to attract significant amount of private investment to complement own efforts. While few aspects of the 10-point approach have already received investment from the private sector and first phase of funding from the government, it is yet to be seen if the UK’s ambitious net zero emission goals are truly feasible.

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Indian Medical Device Rules: Prospects among Ordeals for Manufacturers

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India’s recent notification on regulating medical devices is another step on the government’s behalf to raise healthcare standards in the country. These regulations have implications for all stakeholders in the medical device industry, including medical device manufacturers and importers. The actual impact of these regulations will only be felt in next four to five years, once the regulatory regime comes into effect. However, based on some of the specific regulatory requirements, it is not difficult to ascertain what lies ahead for manufacturers and importers.

In 2019, Indian medical device industry was worth US$9 billion and is expected to reach US$14 billion by 2025. India imports nearly 70% of its medical devices, particularly high-end medical equipment including cancer diagnostics, medical imaging, ultrasonic scans, and PCR technologies, among others, the demand for which is met by multinational companies. The key medical devices that India imports include electronics and equipment – 53%, consumables – 14%, surgical instruments – 10%, IVD reagents – 9%, implants – 7%, and disposables – 7%. Domestic medical device market comprises mainly of small and medium medical device manufacturers with a large portion with turnover of less than US$ 1.3 million.

New Medical Device Rules – Prospects among Ordeals for Manufacturers

For many years, Indian medical device industry has dealt with a lot of challenges owing to lack of regulations. However, with the new medical device regulatory system, the scenario is expected to improve and reduce concerns among the device manufacturers around the lack of standardization and best practices. We discussed the new regulations of medical devices and their impact on various stakeholders in the healthcare sector in our article Indian Medical Device Rules: a Step towards a Better Future in February 2020.

Impact of new regulations on device manufacturers

Once the new regulations come into play, all manufacturers will have to maintain quality standards to avoid any punitive action by the regulator, as compromise on quality could result in suspension or cancellation of their license disabling them for doing business in the Indian market.

In order to assure quality, manufacturers will have to focus on quality management best practices to meet the quality objectives. This would mean creation of quality manual, documentation and execution of the quality-related procedures, and maintenance of quality-related records. Establishment of a quality assurance unit and installation of IT system to support quality-related processes will be the two key steps towards achieving quality objectives.

However, all this will not be easy to achieve from a financial viewpoint for manufacturers, considering majority of players are small and medium-sized. As an indicator, the average cost per year of having a five member quality assurance team in place can be anything between US$ 27,000 to US$ 34,000, which would account for about 2% of the annual turnover for a medical device company reporting US$ 1.3 million in sales (65% of the Indian medical device companies earn less than that). This would be a significantly high expense and, if incurred, is likely to be passed on to consumers.

The amount of expenditure on IT-related infrastructure for implementation on QA would depend primarily on two things. Firstly – the kind of medical device being manufactured (while some medical devices work on the principle of embedded software others do not require software-related quality checks, such as syringes, masks, head covers, etc.). Secondly – the extent to which a manufacturer wants to invest in IT (based on global standards, it would come to around 15-20% of annual IT budget).

Spending on IT infrastructure should be considered as a long-term investment, considering this would be required not only to ensure compliance on quality assurance but also to be done if the company wants to compete in export markets. In any case, the manufacturer would spend less than 1% of its annual revenue on IT for achieving quality objectives.

The government also wants all the device manufacturers to be compliant with Good Manufacturing Practices (GMP), laid down under the Drugs and Cosmetics Act of 1940, and currently introduced as a self-audit or self-assessment activity.

Getting a GMP certification (that confirms a firm uses quality assurance approach to ensure that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization) for a single device is likely to cost less than US$ 135 for the manufacturer. Considering a manufacturer produces a range of devices, most of the small device manufacturing units do not follow the voluntary practice of attaining a GMP certificate citing certification costs (for the entire range of devices manufactured) and renewal fees (for each device after a certain number of years) to be adding to their overall expenses, but not significant enough to be passed on to customers. However, on the positive side, if companies were to get GMP certification, it would make their products compliant as per international standards making them more competent in the export market.

Road ahead for importers

Imports constitute a sizeable part of the medical device market in India. It is easier for importers now to place their products in the Indian market considering that there is a streamlined regulatory standard in place highlighting regulatory approval procedures to be followed in India, as against only the FDA (US Food and Drug Administration) or CE (Conformity Europé) approved products that were allowed to enter the market earlier. This will limit the importers’ cost required for approvals to market in India, rather than requiring marketing approval from international agencies.

Registration fees, license fees, and all duties levied for importing devices in India have been explained paving a clearer pathway for importers to operate in the market. Additionally, a list of forms specific for import purposes, required to apply for medical device approval has also been revealed.

All these practices and clarifications from the regulatory bodies have made it more convenient for manufacturers to import products. Clarity on import-related regulations is expected to make it easier for the importers to bring products to India thereby creating more challenges for the domestic players; however, it is too early to say how the market will evolve and which product segments will witness intensified competition in the next four to five years.

EOS Perspective

From the healthcare industry’s standpoint, governments’ step to ensure that medical devices available in the market meet quality standards in the future is positive and welcomed as it brings assurance of superior quality products for the people using them.

It is the small and medium sized enterprises that make up the low priced, high volume market segment of the medical device industry in India, that will need to make major operational changes and keep a close watch on the cost of compliance on quality aspect. The added cost aspect, if encountered, for developing high-quality products is most likely to hit them the hardest (especially the micro units and small-scale manufacturers) leaving them with no option but to pass on the increased cost onto the consumers. Larger players (5% manufacturers) are likely to remain practically unaffected. Nevertheless, it will be interesting to watch how these regulations shape the operations of device manufacturing companies functioning in India.

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The EU Green Deal – Good on Paper but Is That Enough?

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The EU, which has always been ahead of the curve in tackling climate change and ensuring emission control, has rolled out a new EU Green Deal in December 2019. The Green Deal is the most ambitious environmental policy devised by the EU and encompasses several targets and policy measures that will require a complete overhaul in how business across sectors is currently done in the region.

In the beginning of December 2019, European Commission President, Ursula von der Leyen, unveiled a suite of policies known as the EU New Green Deal and called it Europe’s ‘man on the moon moment’. EU’s Green Deal is aimed at decarbonizing the economy and encompasses a host of policy measures including a plan to ensure EU reaches net-zero emissions by 2050.

To this effect, it has also increased its carbon emission reduction targets from 40% to 55% for 2030. This is the ubiquitous goal for the Commission and all its measures and policies are to be aligned to achieve this objective. Thus, the EU Commission is expected to review and align laws and regulations, such as the Renewable Energy Directive, Energy Efficiency Directive, and Emissions Trading Directive among many others, over the next couple of years to ensure that they are tuned to support the ambitious climate goals. Moreover, taxation will also be aligned with climate objectives to ensure effectiveness.

Policy measures

In order to achieve this objective of carbon neutrality, the EU Commission is focusing on energy efficiency since the production and use of energy across the EU states accounts for 75% of EU’s greenhouse gas emissions. The EU member states are revising their energy and climate plans to ensure higher dependence on renewable sources (especially offshore wind energy production) and phasing out coal and gas-based energy. Moreover, the Commission has also guided member states to review and update their energy infrastructure to ensure the use of innovative and energy-efficient technologies such as smart grids and hydrogen networks.

The Commission is also working towards adopting a new EU industrial strategy along with a new circular economy action plan. The plan will focus on decarbonizing and modernizing several energy-intensive industries, such as steel, chemicals, and cement. It will also include a ‘sustainable product policy’ that will prioritize reducing and reusing materials before recycling them. Moreover, while the circular economy action plan will be applied across all sectors, it will be most relevant for resource-intensive sectors such as textiles, construction, electronics, and plastics.

The plan will focus on fostering new business models that drive sustainable use of resources, set regulations and minimum standards to prevent environmentally harmful products from being sold in EU markets, as well as set a regulatory framework to ensure that all packaging in the EU is reusable or recyclable in an economically viable manner by 2030. In addition to this, the Commission aims at achieving ‘clean steelmaking’ by 2030 by using hydrogen for the process and introduce new legislation by 2020 to ensure that all batteries are reusable and recyclable.

Understanding that construction, use, and renovation of buildings account for a significant part (about 40%) of energy consumed in the EU, the Commission aims at improving energy efficiency in this sector by focusing on more frequent renovations. A quicker renovation rate helps improve the energy performance of buildings and is effective in lowering energy bills and reducing energy poverty. Currently, the annual renovation rate of buildings in the EU states ranges between 0.4% and 1.2%. However, the Commission is looking to at least double the renovation rate to reach its energy efficiency and climate objectives.

In addition to this, the Commission is also working towards curbing carbon emissions from transportation, which accounts for about 25% of EU’s total greenhouse gas emissions. In order to achieve carbon neutrality by 2050, the current transport emission levels would be needed to be cut down by about 90%. To attain this, the Commission has planned for significant investment in boosting electric vehicles and plans to deploy 1 million public recharging stations across the EU states by 2025. Moreover, in July 2021, the Commission plans to revise the legislation on CO2 emission performance standards for cars and vans to achieve its target of zero-emission mobility by 2025.

With regards to commercial transport, the EU Commission aims at pushing automated and digitized multimodal transport. It aims at shifting 75% of inland freight currently carried by road to rail and inland waterways. Moreover, it aims at deploying smart traffic management systems and sustainable mobility services that will facilitate a reduction in congestion and pollution.

The EU Green Deal – Good on Paper but Is That Enough by EOS Intelligence

The Commission also plans to align agriculture and food production with its climate goals. To this effect, the Commission is expected to present a ‘Farm to Fork’ strategy in spring 2020, which aims to introduce and strengthen policies in the agriculture and fisheries space so that they are well equipped to tackle climate change and preserve biodiversity. As per the Commission’s new proposal, 40% of the agricultural policy’s budget and 30% of the maritime fisheries fund within the EU 2021-2027 budget will contribute to climate action and objectives. In addition to this, the ‘Farm to Fork’ strategy aims at significantly reducing the use of chemical pesticides, fertilizers, and antibiotics and in turn increase the area under organic farming.

In addition to agriculture, the EU Commission also aims at preserving and restoring biodiversity. To this effect, the Commission will present a new ‘Biodiversity Strategy’ by March 2020, which will be shared at the UN Biodiversity Summit to be held in China in October 2020. The biodiversity strategy is expected to be brought to action in 2021 and will cover measures aimed to address the key drivers of biodiversity loss such as soil and water pollution. The policy will also encompass a new EU forest strategy that will focus on afforestation, forest preservation, and restoration, which in turn will increase CO2 absorption and aid EU’s ambitious climate goals.

Lastly, the EU Commission plans to reach a ‘pollution-free environment’ by 2050. For this purpose, it plans to review and revise measures that monitor pollution from large industrial installations. Moreover, to ensure a toxic-free environment, the Commission will present a sustainable chemicals strategy that will protect the environment (and citizens) against hazardous chemicals and encourage innovation for the development of safe and sustainable alternatives.

Global trade

The EU’s Green Deal is ambitious, with measures in place to achieve this goal. However, the economic bloc cannot realize this goal in isolation. To get other countries to act on climate change and also prevent the influx of cheaper imports from countries that do not have similar strict policies on carbon emissions, the EU plans to propose a border adjustment carbon tax. This carbon tax is expected to be introduced by 2021 with an initial focus on industries such as steel, cement, and aluminum. The tax may hamper imports from the USA and China as well as smaller countries that cannot afford such climate-based policy measures. However, there is still some ambiguity regarding the tax as it may breach WTO rules, which require equal treatment for similar products, whether domestic or international.

Investment

To achieve this arduous goal, the EU will require a significant amount of additional investment. For starters, the Commission will require additional investment of about EUR260 billion (~US$288 billion) per annum only to achieve the 2030 goal (of reducing carbon emissions by 55%). This is about 1.5% of the EU’s 2018 GDP. Thus it is safe to assume that the investment required for achieving zero emissions by 2050 will be much higher.

The magnitude of the investment requirement will call for participation from both the public and private sector. To achieve this, the commission will present a Sustainable Europe Investment Plan, which will help meet the additional funding needs. The Plan will provide dedicated financing to support sustainable projects in addition to building a proposal for an improved regulatory framework. The commission has also proposed to dedicate at least 25% of the EU’s long-term budget towards achieving climate-based objectives. Moreover, the European Investment Bank (EIB), which has about EUR550 billion funds in its balance sheet, has also pledged to increase its lending towards green projects, thereby becoming a climate bank of sorts. While EIB is already in the process to phase out financing fossil fuel dependent projects by 2021, the bank aims for 50% of its financing to go towards green projects by 2025 (up from 28% in 2019).

In order to ensure an easy and fair transition to climate neutrality, the Commission plans to mobilize a EUR100 billion fund to help regions most dependent on fossil fuels or carbon-intensive sectors. The fund, also called the ‘Just Transition Mechanism’ fund will be funded from the EU’s regional policy budget as well as the EIB. The fund will be used primarily to support and protect citizens most vulnerable to the transition by providing access to re-skilling programs, technical assistance, jobs in new sectors, or energy-efficient housing.

Moreover, the Horizon Europe research and innovation program will also contribute to the Green Deal. As per a new agreement between the EU members in May 2019, 35% of the EUR 100 billion (US$110 billion) research budget for 2021-2027 will be used for funding clean tech and climate-related projects.

With regards to the private sector participating in this green transition, the commission will present a Green Financing Strategy in Q3 2020, which is expected to incentivize the private sector to invest in sustainable and green projects.

To this effect the Commission has created a classification system that for the first time defines what is considered as ‘green projects’ or ‘sustainable economic activities’. This classification is also termed as the ‘green list’ or ‘taxonomy’. This will help redirect private and public capital to projects that are actually sustainable and in turn help the transition to climate neutrality and prohibit ‘greenwashing’, i.e. the practice of marketing financial products as ‘green’ or ‘sustainable’ when actually they do not meet basic environmental standards.

Moreover, it will be made mandatory for companies and financial institutions to provide full disclosure on their climate and environmental impact to clearly lay out how their portfolio stands with regards to the set taxonomy criteria. This is expected to not only increase the transparency of the financial markets but also steer more private investments towards financing an economy that is aligned towards a green transition.

 

The Taxonomy Criteria

The EU Commission set out a basic framework to define what can be termed as a sustainable economic activity. It sets out six environmental objectives and four requirements that need to be complied with in order to make it to the green list.

Six objectives are as follows:

1.       Climate change mitigation

2.       Climate change adaptation

3.       Sustainable use and protection of water and marine resources

4.       Transition to a circular economy

5.       Pollution prevention and control

6.       Protection and restoration of biodiversity and ecosystems

 

Four requirements that need to be met to qualify are as follows:

1.       Must provide a substantial contribution to at least one of the six environmental objectives

2.       Must not provide ‘any significant harm’ to any of the other environmental objectives

3.       Must have compliance with robust and science-based technical screening criteria

4.       Must have compliance with minimum social and governance safeguards

While this provides a general framework, detailed rules and thresholds along with a list of sustainable economic activities will be assessed and developed based on recommendations from a ‘Technical Expert Group on Sustainable Finance’, which is advising the European Commission on this matter.

 EOS Perspective

The Green Deal makes EU the world’s largest economic bloc to adopt such ambitious measures that aim to cease or offset all emissions created by them by mid-century. As per climate scientists, this is necessary to ensure that global temperatures do not rise by more than 1.5-2˚C above the 1990 levels.

While these goals sound promising, they are rarely achieved because they are usually not binding. However, in this case the commission announced that the net-zero emission target would be made legally binding. While that does make achieving the Green Deal objectives more promising, many experts still remain skeptical about the bloc’s capability to achieve it. This is given the fact that the EU has failed to meet 29 (out of 35) environmental and climate targets for 2020. These include energy savings, air, water, and soil pollution, etc.

Moreover, the plan can only be achieved if the EU Council, Commission, and the Parliament, come together and work in tandem and in a timely manner and also work individually with member states to ensure guidelines are converted into actions. For instance, currently CO2 are taxed at different levels across member states (EUR 112 (US$123) per ton in Sweden, EUR 45 (US$50) per ton in France and tax-exempt in Germany). To get all member states to agree at a common point and have a pan-EU strategy is a difficult task. Thus, while the EU has devised an all-encompassing strategy and dedicated significant funds to the same, results will only materialize if there is inclusive and credible implementation of the plans.

In addition to this, there is also some criticism of the policy at a global level, with some nations indicating that it has more to do with protectionism rather than climate goals, owing to its policy on border adjustment carbon tax. Since the EU has more measures and flexibility to cut emissions in its own region, it creates an unfair disadvantage for its trade partners (some of who are still in the developing stage and cannot afford such measures). Moreover, given the technical and political complexities of the carbon tax (with regards to WTO and other trade treaties), it is unlikely that it will be implemented before 2024, which is when the current President Ursula von der Leyen’s term gets over. This will further make its implementation dicey.

However, all being said, the EU Green Deal is a policy in the right direction. With the blueprints being laid down, now it all depends on the implementation. While few measures may be difficult to achieve, there is a lot of unanimous backing for green finance. An increasing number of investors is moving away from ‘brown’ assets towards climate-friendly investments. Irrespective of the outcome or success of the Green Deal, green investments are definitely the future. Thus companies, both within the EU as well as globally, must look at innovating their processes as well as products/services to align them with climate goals to lure both public and private funding in the long run.

Indian Medical Device Rules: a Step towards Better Future
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Indian Medical Device Rules: a Step towards a Better Future

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Healthcare sector in India is witnessing a churn as a result of the government’s attempt to make healthcare more affordable and to promote domestic healthcare industry. Recent medical devices-related notification is also part of the government’s vision for a better managed healthcare market, though it has ignited a debate about the future of medical device industry. There is hope as well as an apprehension among the stakeholders, as they wait for the notification to become fully effective in next three years.

The Notification

In the second week of February 2020, India’s Ministry of Health & Family Welfare announced that all medical devices sold in the country would be treated as drugs from April 1, 2020 onward and would be regulated under the Drugs and Cosmetics Act of 1940. To understand the context of this announcement, we will have to turn the clock back by about three years.

In 2017, Indian government announced Medical Device Rules-2017 (MDR-17) – a set of rules, which included:

  • Classification of medical devices into four classes (A, B, C, and D), based on the associated risks, i.e. low, low moderate, moderate high, and high risk devices
  • Procedures, including the required documents, for registration and regulatory approval of devices
  • Details regarding manufacturing, quality audit, import/export, and labelling-related requirements

There was no risk-based classification of medical devices prior to 2017 and it was also difficult to introduce new products, as the approval procedures were undefined. In case of imports, only the products approved by Conformité Européene (CE) and the US Food and Drug Administration were allowed. MDR-17 were expected to unlock the potential of Indian medical device market by introducing a well-defined regulatory regime, while assuring quality products to consumers.

Under the rules, a medical device had to be notified as ‘drug’ under the Drugs and Cosmetics Act to be regulated by Central Drugs Standard Control Organization (CDSCO):

  • Initially, 15 categories of medical devices (syringes, stents, catheters, orthopedic implants, valves, etc.) were notified as drugs
  • In 2019, the government notified (effective April 2020) another eight categories – MRI equipment, PET, bone marrow separators, dialysis machines, CT scan and defibrillators, etc., thereby placing a total of 23 categories of medical devices under drugs

The February 2020 notification, called Medical Devices (Amendment) Rules, 2020, has made the entire range of medical devices available in India (about 5,000 different types) under the ambit of drugs, as opposed to 23 categories before the announcement. The compliance requirements are to be enforced in a phased manner, with 30 months given to low and low moderate risk devices and 42 months for moderate high risk and high risk devices.

Indian Medical Device Rules - A Step Towards Better Future by EOS Intelligence

The Concerns

The February notification has drawn reactions, most of them positive, regarding the future from those associated with the industry. There are some concerns as well, such as:

  • What if the device rules accord unrestrained power to drug inspectors due to medical devices being regulated under the Drugs and Cosmetics Act?
  • Would the cost of quality compliance be substantial for device manufacturers?
  • Would the government resort to price control of medical devices, as it does in case of drugs?

Though the concerns are valid, they are unlikely to cause immediate disruption, as there would be at least 30 months (time given for enforcement of compliance for class A and B devices) after the notification date for the rules to start impacting the industry. An increased cost of compliance is a possibility, however, it would be found across the industry and should not impact only specific companies or a specific product segment.

At present, for price control purpose, four medical devices – cardiac stents, drug-eluting stents, condoms, and intrauterine devices – are in the national list of essential medicines that can be further expanded. However, the expansion cannot be directly linked with the medical device rules, which were primarily framed to ensure a better operating environment for industry players. For instance, from the initial list of 15 categories (i.e. about 350 devices) under MDR-17, only cardiac stents and knee implants were brought under price control (condoms and intrauterine devices were already under the price control regime when MDR-17 were introduced).

Impact on stakeholders

Indian medical device industry is expected to evolve under medical device rules (including the February 2020 notification). Even if the impact of the rules is speculative at present, it is interesting to take a look at their potential effect on key stakeholders in the coming years. While the patients appear to be the greatest beneficiaries due to improvement in quality of treatment, wholesalers and retailers of medical devices may have to prepare for a more demanding operating environment.

Indian Medical Device Rules - A Step Towards Better Future by EOS Intelligence

Read more on the implications for all stakeholders in the medical device industry in India in our article: Indian Medical Device Rules: Prospects among Ordeals for Manufacturers

EOS Perspective

Decision to notify all medical devices as drugs for regulatory purpose was a result of a long consultative process, which involved various stakeholders and experts, including Drugs Technical Advisory Board (DTAB). The industry was expecting such an announcement, as the government had previously shown its intent to do so. Hence, the February 2020 notification was only part of the process that was initiated in 2017 with the introduction of medical device rules. The notification is a show of intent by the government of India towards building a better regulated industry offering more quality products, thereby raising the standards of healthcare in the country. The phased implementation of rules is likely to provide enough time for the industry to adapt according to new regulatory requirement.

Any comment on the future of Indian medical device industry on account of probable price control measures would be purely speculative, as it is difficult to predict the outcome of such steps at present. The case in point is of stents, which were brought under price control regime in 2017. There were fears that the move might kill the sector; however, the stent-related procedures have not witnessed decline despite the multinational companies taking their high end products off the shelf, indicating that the domestic manufacturers have been able to cater to demand.

While the end-users can view the medical device rules as a means to provide better care to them, the device manufacturers can also look for positives, especially when the rules are seen along with the government’s other efforts, such as Make in India initiative, to boost domestic manufacturing. Device classification and the associated regulatory requirements have removed ambiguity for the manufacturers of medical devices in India. This clarity might also fast track investments in the sector, as the potential investors now know what to expect while operating in India. Under Make In India, up to 100% foreign direct investment is permitted in medical devices through automatic route.

by EOS Intelligence EOS Intelligence No Comments

Commentary: India’s Automobile Sector Breakdown Causing Economic Distress

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Over the past few months, a lot has been said about the shrinking automobile sales in the Indian market. Touted as one of the key drivers of India’s economic growth, the automobile industry is facing the worst slowdown in two decades as production and sales numbers continue to drop month after month sending the sector in a slump. While the government has made efforts to improve the situation, it will take more than just policies and measures to flip the status quo and bring the industry back on the growth path.

Indian automotive industry witnessed a period of growth during the first term of Modi government – we wrote about it in our article Commentary: Indian Automotive Sector – Reeling under the Budget in February 2018. However, over the past year, the auto sector is in shambles and far from recovery. The sector that contributes 49% of the manufacturing GDP in the country (and more than 7% to the country’s total GDP) has shown decline in growth in the past 18 months as the numbers continue to fall each month. The slowdown is so severe that it has affected all aspects of the business leading to piled up inventory, stalled production lines, decelerating dealership sales, delayed business investments, and job loss.

Quintessential factors that triggered the slowdown

There are various reasons that have plagued the auto industry in the recent months. One of the key factors is the inability of NBFCs (Non-Bank Financial Companies) to lend money. NBFCs, which largely depend on public funds (mainly in the form of bank borrowings, debentures, and commercial paper), have been facing liquidity crunch in the recent past as both public sector and private sector banks have discontinued lending money. This had a double effect on the auto sales – firstly low liquidity has restricted NBFCs ability to finance vehicles, thus having an adverse impact on sales, and secondly, the limited availability of funds bulleted the cost of financing vehicles thereby making them relatively more expensive, further worsening the sales scenario.

In October 2018, the Supreme Court of India announced that no BS-IV cars shall be sold in India with effect from April 1, 2020 (all automobiles should be equipped with BS-VI compliant engines, with an aim to help in reducing pollution in terms of fumes and particulate matter). Owing to this, consumers have delayed their plans to purchase vehicles expecting automobile companies to offer huge discounts in the early months of 2020. And to clear out their existing stock of BS-IV vehicles, it is highly likely that the companies will offer massive concessions before the deadline hits. Delay in purchase of vehicles on consumers’ end has contributed to the overall low sales.

Additional factors that add to the downfall include changes in auto insurance policy (implemented in September 2018) under which buyers have to purchase a three-year and five-year insurance cover for car and two-wheeler, respectively (as against annual renewals), inclusion of additional safety features (including airbags, seat-belt reminders, and audio alarm systems) in all vehicles manufactured after July 1, 2019 adding to the manufacturing cost for the OEMs, and stiff competition from growing organized pre-owned vehicle market which has doubled in size in less than a decade (the share of the organized channel of the pre-owned car market has increased to 18% in 2019 from 10% in 2010). Customers have been passive on buying new vehicles as the total cost of ownership goes up due to an increase in fuel prices, higher interest rates, competition from used cars segment, and a hike in vehicle insurance costs.

Government initiatives to help the auto sector recover

To boost demand for automobiles and offer some respite to the businesses operating in the space, the government announced a number of measures and policies. These include lifting the ban on purchase of vehicles by government departments (the ban was introduced in October 2014), which is hoped to result in loosening of stocked-up inventory and getting sales for automakers, component manufacturers, and dealers. Government also announced additional 15% depreciation on new vehicles for commercial fleet service providers acquired till March 2020 with the aim to clear the high inventory build-up at dealerships.

Other than lifting the ban and price reductions, the government also announced that all BS-IV engine-equipped vehicles purchased until March 2020 will remain operational for the entire period of registration. This will have a two-fold effect – firstly, automakers will be able to push out their stock without having to upgrade existing models and make them BS-VI-complaint (since no more BS-IV-complaint vehicles will be registered post March 2020 and manufacturers will have to upgrade to BS-VI from BS-IV emission standard on the old stocks) thus clearing old inventory, and secondly, consumers can expect much higher discounts. This is expected to provide enough movement within the auto sector, both in terms of sales and revenue generation.

Government has also taken steps to stabilize the NBFC crisis where a separate budget of US$ 14 billion (INR 100,000 crore) has been announced to refinance selected NBFCs. While it is clear that these limited funds will not last long, currently, any step taken to recover from the situation is welcomed.

Though considered temporary, the relief measures offered by the government have gained traction in the industry and players believe that these provisions will have a positive impact on the buyers’ sentiment, even if for a short period of time.

Implications of the auto industry crisis

The slowdown is expected to have a negative impact across all aspects of auto business, especially in the short term. Drop in sales has led manufacturers to decrease production (and even stop production for a certain period of time), cut down overall costs, and reduce headcounts thus weighing down the overall automotive sector.

The months leading to reduced sales did not only impact the production capacities but also resulted in the loss of more than 350,000 jobs. In the coming months, many more risk losing their jobs owing to plant shutdowns, dealership closures, and small component manufacturers going bankrupt.

The cost of vehicle ownership has also increased. Automobiles attracts the highest GST slab of 28%, and this, coupled with the varying road and registration charges imposed by state governments, makes the upfront cost of the vehicle exorbitant for a large segment of consumers (especially the working middle class for whom a two-wheeler or a small segment car is a basic necessity rather than a nice-to-have convenience) making it almost impossible for them to but it.

Given that the automobile sector works in conjunction with other industries, the current slump in auto sales will pull down ancillary industries including parts and components, engines, battery, brakes and suspension, and tire, among others. Considering the fact that the sector contributes nearly half to the country’s manufacturing GDP, if the issue at hand is not addressed immediately, it will further add to the ongoing economic crisis within the country worsening the situation altogether.

EOS Perspective

Policies announced by the Modi government to revive the tumbling automobile sector only seem to mitigate the negative sentiments circling about the future of the industry. However, at this stage, what the industry really needs is a stimulus package in the form of tax incentives or liquidity boost to immediately change things on the ground level.

There is an urgent need of a remedial course of action on the government’s part to stop the vehicle sales from dropping further. As an immediate relief to boost sales and invigorate the auto sector, the government should implement a GST cut on vehicles. This would kick-start vehicle demand almost instantaneously that would work in favor of the automobile industry – manufacturers (to resume halt production), dealers (to clear inventory), and parts makers (to resume small parts and component manufacturing), help resuscitate lost jobs, and contribute, to a small extent, to strengthen country’s slow economic growth.

However, with the government turning a blind eye to industry needs (lowering the GST slab), there is only so much the business owners can do. Under this current scenario, unless the government takes some drastic measures that ensure validation in backing automakers, auto ancillary businesses, and dealers, the sector is unlikely to recover soon. Provisional policies and short-term measures can offer momentary relief but not the survival kick the auto industry is in dire need of.

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