REGULATORY LANDSCAPE Archives

06/03/2024by EOS Intelligence EOS Intelligence No Comments

Soaring Healthcare Costs in the USA: Is Greed Winning Over Welfare?

323views

Americans have been struggling with access to affordable healthcare for years, with thousands of stories of an unexpected illness driving a patient to bankruptcy. Meanwhile, the USA spends much more than European nations on healthcare but covers the smallest percentage of the healthcare costs. Wasteful spending, excessive administrative costs, no limit to medicines prices, lack of a single unified interface system, and passive attitude by the government are all building blocks of a wall separating Americans from the quality and affordable healthcare system expected from any developed country.

According to a 2020 article published by Harvard, the annual cost of healthcare in the USA was around US$3.5 trillion, of which around 33% is believed to have been squandered. Simultaneously, healthcare costs are soaring, contributing significantly to several issues around the delivery and affordability of healthcare in the USA. The same Harvard article revealed that about 40-44% of Americans decided to omit or postpone medical treatment, tests, or care owing to their high costs. Although the USA has the highest national healthcare expenditure, the country registers one of the lowest life expectancies among the developed economies. Additionally, around 10% of the population does not have health insurance.

This problem is so deep-rooted and widespread that the issue of healthcare costs was referred to as the “tapeworm of American economic competitiveness” by investor Warren Buffet. Almost 67% of the US population wishes the federal government to regulate healthcare prices in the country. Yet, despite it being such a grave problem, the US government does not seem to be taking any (visibly) constructive measures to resolve it. While significant political aspects are certainly at play, a deep dive into the cost drivers of the US healthcare system might shed some light on the complexity of this issue.

Soaring Healthcare Costs in the USA – Is Greed Winning Over Welfare by EOS Intelligence

Healthcare administrative costs hold the lion’s share of total healthcare expenditure

One of the major components of healthcare costs in the USA is the annual cost of healthcare administration at US$1,055 per capita, according to a 2021 estimation by the Peterson Foundation. The US spending on healthcare administrative purposes is by far the highest globally. Compared with Germany, the second-highest spender on healthcare administration at US$306 per capita, the stark difference of US$749 per capita speaks volumes about the current situation in the USA. The country also registers the world’s highest share of administrative costs in total healthcare costs, at around 15-30% annually. Wasteful administrative spending is estimated to contribute about half of that share (7.5% to 15% of the country’s total healthcare spending), translating to anywhere from US$285 billion to US$570 billion in 2019.

The USA spent around US$950 billion in 2019 on healthcare administration, which translates to 25% of the national healthcare expenditure (NHE) that year. A significant part of the excessive administrative expenditure is billing and insurance-related costs (BIR), including overhead costs for medical billing and services such as claim submission, claim reconciliation, and payment processing. Profits made by the insurance companies account for the highest share of BIR costs. Healthcare providers also get part of these administrative costs for note-taking and record-keeping during the medical billing process. According to an article published by Harvard in 2020, there are occupations in US healthcare that do not exist elsewhere, such as medical-record coding to claim-submission specialists. Further, the article claims that in other countries, such as Germany and Switzerland, where multiple payers and private providers exist, healthcare administration costs less than 50% of the USA equivalent.

As per 2019 McKinsey research, the USA could decrease healthcare administrative expenditure by 30% through automation and streamlining of the BIR processes. Claims processing software enables automation of BIR processes, however, only 15% of US hospitals employ such software, as per Definitive Healthcare tech data.

Healthcare services costs, including physicians’ salaries, empty patients’ pockets

A 2018 JAMA study revealed that physician salaries in the USA were higher than in other developed countries. A survey by Medscape in 2021 revealed that physicians earned the most in the USA compared to other developed countries. On average, the annual income of physicians in the USA was US$316,000, followed by Germany (US$183,000) and the UK (US$138,000).

As per 2019 Commonwealth Fund research, Americans are much less likely to consult a doctor in case of a health issue, at half the rate compared to other developed countries. This can be attributed to the fact that the cost of healthcare services is considerably higher in the USA vis-à-vis other developed nations. According to a 2017 report, the average cost of a coronary artery bypass graft (CABG) surgery in the USA was US$78,100, whereas the same procedure cost only US$11,700 in the Netherlands. While the procedure cost is already far lower, in the Netherlands, patients will likely have the procedure cost fully covered by insurance without any co-payment. The USA also reported higher costs for outpatient procedures such as MRI scans and colonoscopies compared with other developed countries.

Skyrocketing prescription drug prices further inflate healthcare costs

As per OECD, in 2019, the average spending on prescription drugs by an American was about US$1,126 per capita, which was over double that in other developed nations. As per CMS, prescription drug spending in the USA by the federal government is expected to grow by 6.1% through 2027.

The growth in prescription drug spending could be attributed to increased focus on specialty pharmaceuticals and precision medicine. Specialty medicines are experimental therapies for treating cancers, autoimmune diseases, or chronic conditions. Some specialty medicines employ genetic data to provide highly targeted, personalized therapy. Owing to the complex nature of these drugs, they are generally expensive to develop and distribute.

For instance, a novel specialty drug called Hemgenix to treat hemophilia B is the most expensive drug ever approved by the FDA. The price of a single infusion of this gene therapy is around US$3.5 million. No healthcare providers have submitted a claim for Hemgenix so far in 2023.

Apart from specialty medicines, pricing strategies for drugs in general play a significant role in soaring healthcare costs in the USA. Drug producers set a list price based on their product’s estimated value, and the price list can be increased by the producers as they see fit. In the USA, there are few regulations to curb producers from increasing drug prices in this way.

Chronic diseases add fuel to the fire of escalating healthcare costs

As per the CDC, six out of ten adults in the USA have a chronic disease or condition. The most common chronic diseases or conditions in the USA include heart disease, stroke, cancer, diabetes, chronic kidney disease, and chronic obstructive pulmonary disease (COPD). Furthermore, according to 2022 research published in the National Library of Medicine, of the population 50 years and older, the number with at least one chronic disease is estimated to increase by 99.5% from 71.522 million in 2020 to 142.66 million by 2050.

There is a robust correlation between the prevalence of chronic diseases and rising healthcare costs. As per a report from the American Action Forum, the USA spends about US$3.7 trillion annually for the treatment of chronic health diseases and the consequent loss of economic productivity. Routine office visits, prescriptions, outpatient treatments, or emergency care account for most of this healthcare spending in the USA.

Expanding geriatric population contributes to rising healthcare costs

According to the US Census Bureau, 21% of the US population is expected to be 65 years or older by 2030. The growing aging population is expected to drive healthcare costs in the USA in two ways: through Medicare enrollment growth and the increase in the prevalence of more complex and chronic conditions. Medicare had over 65 million beneficiaries as of March 2023, a number that is expected to increase by 2030 dramatically. This enrollment growth will impact NHE since Medicare is a publicly funded program. As per the CMS, in 2020, the USA spent US$900.8 billion on Medicare, and the CMS expects that Medicare spending will surge by 7.6% annually through 2028.

The elderly population is vulnerable to chronic conditions such as hypertension, high cholesterol, diabetes, coronary heart disease, and Alzheimer’s disease, among others. According to the National Council on Aging, 80% of older Americans have a chronic condition, and 77% of older adults have two or more chronic conditions. These chronic conditions will require ongoing treatment or long-term care at a nursing home or assisted living facility. These outcomes will account for increasing healthcare costs and overall national healthcare expenditure in the USA.

Greed over welfare

Corporate avarice is another factor said to be responsible for the rising healthcare costs in the USA. Insulin list price in the USA is 10 times higher than that in Canada. Not only pharma companies but also renowned hospitals charge more for the same service compared with less renowned hospitals. This applies to various services, from complex surgeries to simple X-rays.

Price regulation is the only solution to this problem that could be implemented with enough political will. The US state of Maryland has introduced this regulation for hospital services, while most European countries have regulated the prices of pharmaceuticals. However, implementing price regulation would mean that the compensation of the top management executives or the CXOs would decline, or the budget for R&D would reduce. This causes much resistance among top management executives to arrive at a constructive decision of choosing between self or service. However, the fact that patients delay treatment because of rising prices speaks strongly in favor of introducing at least some level of price regulation.

EOS Perspective

Standardization is one of the key ways to decrease administrative costs. Just for comparison purposes, checking out of a grocery store is easy because all products possess bar codes, and all credit card machines are the same or uniform. Similarly, mobile banking and inter-banking are straightforward since the Federal Reserve has set standards for how banks should interface with each other.

However, the American healthcare system has been immune to such a standardization. Every health insurer needs a different bar-code-equivalent and payment-systems submission. In addition, it is tough to send electronic medical records (EMRs) from one hospital to another because there is no mandate by the federal government for them to be in compatible formats. Additionally, this lack of standardization benefits many healthcare providers, as they strive to avoid the interchange of EMRs to prevent patients from switching doctors.

Standardization is possible only when prominent stakeholders are involved in it, agree to it, and decide they need it. The largest stakeholder in the US healthcare system is the federal government. Buying capacity and administrative control to compel payers and providers to adopt billing and interface rules to standardize the process lies within the federal government’s responsibilities.

Similarly, a price cap regulation needs to be brought about in the pharmaceutical sector. Price regulation is the only way to lower the prices of prescription drugs. Apart from this, the federal government needs to implement price cap regulation in healthcare services such as X-rays, MRIs, CT scans, etc.

It is the government that should introduce regulations that put caps on drugs and services prices, at least in certain product and service groups. It is the government that should establish the infrastructure to materialize standardization and introduce a deadline by which all interactions must be standardized.

However, to date, the federal government only considers providing insurance – particularly Medicare and Medicaid – to people as its role rather than looking out for the entire healthcare system as a unit. This mentality needs to change if healthcare costs are to be brought down.

12/12/2023by EOS Intelligence EOS Intelligence No Comments

Medicine Shortage in the EU: A Deep-dive into Its Causes and Cures

602views

With the proposal of the deeply revamped new EU pharma legislation in April 2023, the EU initiated an attempt to tackle the medicine shortfall that the union has been experiencing for over two decades now. Europe has witnessed a 20-fold rise in reported drug shortfalls from 2000 to 2018, as per research conducted by the Mediterranean Institute of Investigative Reporting (MIIR).

According to the European Data Journalism Network (EDJNet), the problem of drug inadequacies is not novel, although it got under the spotlight during the 2020-2022 COVID-19 pandemic, the energy crisis that started in early 2022, and the beginning of the Russian invasion of Ukraine in early 2022. Ironically, the fundamental reasons responsible for the medicine shortages in the EU are not solely these three events but a mixture of structural, economic, and regulatory factors that the governments often refuse to agree on.

In terms of the magnitude of the shortage during the five-year period from January 2018 to March 2023, Italy experienced the highest inadequacy in absolute terms to the tune of 10,843 medicines, followed by Czechia with 2,699 medicines and Germany with 2,355 medicines. Although Greece witnessed the lowest shortage, with 389 medicines between 2018 and 2023, the median duration for which the shortfall existed was the longest for this country, with 130 days, followed by Germany with 120 days, and Belgium with 103 days. This means that, for instance, in Greece, it is likely to take about four months and eight days for a medicine to be back on the market.

According to a survey regarding medicine shortages in the EU members organized by the Pharmaceutical Group of European Union (PGEU) between mid-November and end-December 2022, all 29 EU countries surveyed recorded drug shortfalls during the past 12 months among community pharmacists (pharmacists in retail pharmacies where the general populations have access to medications). Moreover, around 76% of the respondents agreed that the situation had worsened compared to 2021, and the remaining 24% said the situation remained the same compared to 2021. Not a single country registered any improvement in the situation compared to 2021. Furthermore, the survey also revealed that 83% of the respondents concurred that cardiovascular drugs were in short supply during the last 12 months in community pharmacies, followed by medicines treating nervous system diseases and anti-infectives for systemic use, such as antibiotics (79% each). Owing to the sample size of this survey of 1 response per country covering 29 EU countries, the findings might not be accurate but are likely to illustrate the overall trends correctly.

The problem of medicine shortages is not just limited to EU countries, as the UK is also experiencing acute drug inadequacies, including HRT (hormone replacement therapy) medicines and antibiotics, among other medicines.

In December 2022, the European Medicines Agency (EMA) announced that most EU countries are confronted with drug shortages. The question that arises is what led to the medicine shortfall in the EU and how the EU members can attempt to combat the issue at hand.

Medicine Shortage in the EU: A Deep-dive into Its Causes and Cures by EOS Intelligence

Factors responsible for medicine shortages in the EU

The attributing factors to drug shortages in the EU are mainly a combination of economic, regulatory, and production or supply chain-related causes.

Economic factors

Price cap regulation on generics amidst rising costs hindering production

One of the key reasons for the drug shortfall of medicines, including antibiotics (such as Amoxicillin) in the EU is the fact that generic drug makers are not paid sufficiently for increased production of the medicine to cover the associated costs such as production, logistics, and regulatory compliance costs that are rising steeply.

To add to the woes of most European generic drug makers, the prices of the generics that the respective countries had set have remained unchanged for the past two decades, making the situation much worse.

Additionally, due to regulated prices of generic drugs, numerous European drug producers have shown a lack of interest in boosting their production capacity. This has become particularly relevant during the Russian invasion of Ukraine, which has caused a rise in energy costs. This cost increase affects the smooth functioning of factories that produce everything from aluminum for medicine bottle caps to cardboard for packaging medicines, indicating a rise in drug insufficiencies in the foreseeable future.

According to a Reuters report, six European generic drug industry groups and trade associations, as well as 13 European producers, revealed that many smaller drug makers are battling to be profitable and, therefore, are contemplating if producing antibiotics would be feasible, let alone expanding production capacity.

Government tenders indirectly force generic producers to cut production

Before inviting quotations or tenders, many European governments tend to weigh the generic drug prices with prices in other regional markets or prices of similar drugs in the home market to establish a reference price point that can be used in negotiating with producers. These governments give contracts to those producers who quote the lowest price, resulting in “further downward pressure on prices in subsequent tenders,” as per generic drug producers.

According to many European generic drug producers, the price cap regulation and the tender system of generics have spurred a ‘race to the bottom’. The European generic drug makers bear the brunt of Asian generic drug producers charging less for the same products. Consequently, some European firms were compelled to either decrease production or choose offshore production (of generics and APIs required to produce them) to low-cost locations such as India and China.

Parallel exports aggravate the shortages in low-price markets

Although some European countries have started prohibiting parallel exports (cross-border sale of medicines within the EU by sellers outside of the producer’s distribution system and without the producer’s permission) to other countries, this practice of buying drugs from low-price markets and selling them in high-price markets has resulted in the exhaustion of medicine supplies in low-price markets. This has been noticed in some EU countries such as Greece, Portugal, and Central and Eastern European member states where legislations have been put into effect that make the re-export of pharmaceuticals harder. For instance, drug shortages in Greece have been attributed to the re-export of imported medicines to regions where these medicines are sold at a higher price point than in Greece, as per a news report by the Turkish news agency, Anadolu Agency.

According to a report published by the Centers for European Policy Network in May 2021, the magnitude of parallel imports of medicines occurring in the European Economic Area (EEA) was to the tune of €5.7 billion in 2019. Furthermore, the share of parallel-imported pharmaceuticals varied considerably across European countries. To cite a few examples, Denmark’s share of parallel-imported pharmaceuticals was around 26.2% in 2018, while the corresponding figure for Austria was 1.9% in the same year. Similarly, in 2018, the share of parallel-imported medicines was around 12% in Sweden and 2% in Poland.

Production and supply chain factors

The current lack of a sufficient number of production facilities in European countries can increase the chances of drug shortfalls in the region at the time of any production problem. To illustrate this, the European Medicines Agency (EMA) cited that drug shortages in the EU are caused by production factors, raw material shortages, distribution issues, and high demand due to respiratory diseases and inadequate manufacturing capacities.

Furthermore, many pharma producers utilize the just-in-time concept of inventory management, which improves efficiency, reduces storage costs, and minimizes waste, thanks to producing goods as needed. Due to this, producers often face challenges such as the inability to adapt to changing demand volumes.

Moreover, owing to the innate reliance of drug producers on APIs, variations in the “supply, quality, and regulation” of APIs have affected medicine supplies, according to a report by the Economist Intelligence Unit. To cite an example, pharmacies in Italy have attributed the decline in the making of APIs in China to the shortfall of medicines in Italy, according to a report by Anatolia Agency, the leading Turkish news agency.

Reactions from various stakeholders in the EU pharma market

Starting from proposing a revision of the EU pharma legislation to banning parallel exports of medicines in some European countries, there are many reactions to drug shortages in the EU from various pharma market stakeholders.

New Pharma legislation in the EU by the European Commission

The proposal of the new pharma legislation in the EU by the European Commission in April 2023 came as a reaction to the acute medicine shortage in the region. It proposes measures for producers to provide early warnings of drug shortfalls and necessitates producers to keep reserve supplies in sufficient quantities for times of crisis, such as acute shortages.

Read our related Perspective:
 New EU Pharma Legislation: Is It a Win-win for All Stakeholders?

Price capping cannot facilitate sustainability

European lobby groups supporting generic medicine makers argue that price limits won’t be effective due to growing production and regulatory expenses. There was no system to review medicine prices and adjust them for inflation or when APIs became scarce in most European countries. Moreover, it is exceedingly complex to continue to keep medicines competitive after 10 years of their launch.

Ramped up production by bigger generic drug producers

The pricing framework in Europe is the primary concern of generic drug makers in the long term, not production costs. According to the global supply chain head of Sandoz, Novartis’s generic division, the current inflexible pricing framework prevents generic drug producers from adjusting prices for essential drugs according to changes in input costs.

To illustrate this, the price of 60ml of pediatric amoxicillin in 2003 in Spain was around €0.98 (US$1.05). In the following ten years, the only change that was made was to reduce the quantity of the medicine to 40ml of pediatric amoxicillin, still pricing it at €0.98 (US$1.05). However, no change has been made since 2013.

Some larger generic drug companies are ramping up the production of certain medicines, such as amoxicillin, that are in short supply. To cite a few examples, Sandoz is planning to add extra shifts in its factory in Austria to meet their increased production target of amoxicillin by a double-digit percentage in 2023 vis-à-vis 2022. Additionally, the company plans to start the operation of another expanded factory by 2024. Similarly, GSK also recruited a new workforce and increased shifts in its amoxicillin factories in the UK and France. However, for companies with smaller market shares, such as Teva, things are different as increasing production capacity is not a viable option for them as they are struggling to be profitable, and thus, there is no way they can ramp up production to bridge the market gap.

National governments and drug regulators making big changes

Some European governments are considering making legal changes to ease the current procurement system of medicines in their respective regions. Additionally, some European governments are also striving to ban the re-export of imported medicines. Germany’s government is set to contemplate making legal changes to its tender system for generic medicines in 2023, whereas the Spanish government is planning to review its pricing scheme for certain medicines, which might cause patients to pay a higher price for medicines, including amoxicillin, on a temporary basis. The Netherlands and Sweden have put in place a law that requires vendors to stock six weeks of reserve supplies to mitigate shortfalls.

Several European countries are taking initiatives to prohibit parallel exports or re-exports of imported medicines to preserve domestic medicine supplies. To cite an example, in November 2022, the medicines regulatory body in Greece expanded the list of drugs whose re-export to other countries is prohibited. Another example is Romania, which halted exports of certain antibiotics and pediatric analgesics for three months in January 2023. Also, in January 2023, Belgium issued an official order allowing the respective authorities to stop the export of medicines to other countries during crises such as shortages.

EOS Perspective

Tender or procurement and pricing strategies of medicines in the EU and the UK must be improved after in-depth analysis. This is the only way to improve production in the European region so that future shortages of drugs can be avoided, in addition to curbing heavy dependence on Asia for essential drugs.

Secondly, there needs to be a centralized EU system in place that is designed to track the supply of essential medicines in all member countries, allowing for the identification of early signs of upcoming risks or shortfalls.

The new pharma legislation in the EU is expected to help improve the availability of drugs in situations of health crises, including drug shortages. The EU could reduce medicine shortages across the region over time as it has awarded the EMA more responsibilities and established a new body called HERA that can purchase medicines for the entire union.

EU Push the Maritime Operators to Boost Cybersecurity by EOS Intelligence

23/11/2023by EOS Intelligence EOS Intelligence No Comments

Commentary: EU Push the Maritime Operators to Boost Cybersecurity

Cybersecurity in the maritime sector is of critical importance as sea routes accounted for about three-fourths of the EU’s imports and exports in 2022. The new Network and Information Systems Security Directive (“NIS2 Directive”) aiming to strengthen cybersecurity is expected to enter into force from October 2024 and will impact maritime companies with more than 50 employees or an annual revenue of over €10 million. The NIS2 directive, which will replace and repeal the NIS directive, expands the scope to cover a larger number of companies in the sector as it includes both medium and large-size companies.

Companies may feel burdened by strict NIS2 requirements

To comply with the new requirements, the companies would need to make cyber risk management a focal point for every business strategy and make cybersecurity measures a part of day-to-day operations. NIS2 adoption will not only demand additional investment but also change the way the business is done.

Increase in cybersecurity investments

A total of 156 entities in the water transport sector were subject to the NIS directive in July 2016, as it focused mainly on large enterprises. Under NIS2, this number is likely to increase to 380. In particular, the number of port and terminal operators covered in NIS2 will increase significantly. A senior IT executive from Port of Rotterdam indicated that while NIS covered only a few port stakeholders (~5 companies), more than a hundred companies would need to comply with NIS2.

European Commission indicated that the companies already covered under the NIS directive would need to increase their IT security spending by 12%, while for the companies that were not covered previously but would be covered under the NIS2 framework, the IT security spending would need to be increased by up to 22%.

Frontier Economics, a consultancy firm based in Europe, estimated that the costs of implementing the NIS2 regulation in medium and large enterprises across the water transport sector would be about 0.5% of the total annual revenue across the medium and large water transport companies, which amounts to more than €225 million per year.

Enhancement of OT security

The advent of digitization has resulted in rapid convergence of operational technology (OT) with IT systems, leaving critical OT infrastructure vulnerable to cyberattacks. OT helps monitor and control mechanical processes, making them particularly important for the safe operation of ports and other aspects of the maritime sector.

ENISA, the European Union Agency for Cybersecurity, indicated that from January 2021 to October 2022, ransomware attacks on IT systems were the most prominent cyber threat facing the transport sector and warned that ransomware groups are likely to target OT systems in the near future. NIS2 imposes stringent requirements for critical infrastructure entities, including maritime companies, to beef up cybersecurity from the perspective of both IT and OT.

Traditionally, maritime companies have considered cyber security primarily in the context of IT systems, but now there is a higher focus on OT cybersecurity, and the NIS2 is going to ensure investment momentum in this space. For instance, the Maritime Cyber Priority 2023 report indicated that over three-fourths of the respondents suggested that OT cyber security is a significantly higher priority compared to two years ago.

While NIS2 adoption may seem taxing, benefits are likely to follow

Like any new regulation, the adoption of NIS2 comes with additional costs and implementation hurdles, however, the consequent benefits are likely to outweigh the challenges.

Harmonization of cybersecurity requirements

In August 2023, a senior executive from Mission Secure, an OT cyber security solutions provider, indicated that maritime operators would welcome stringent cybersecurity standards. The maritime industry operates on thin profit margins, making it difficult for companies to invest more in cybersecurity than competitors. Implementation of NIS2 would set cybersecurity standards harmonized across the EU and thus level the playing field in terms of spending on cybersecurity while reducing the risks and losses associated with cyberattacks.

Improved competitiveness

A 2020 study by ENISA suggested that the EU organizations’ cybersecurity spending is, on average, 41% lower than of their US counterparts. NIS2 is expected to drive the necessary investments in cybersecurity.

Moreover, given the international nature of the maritime industry, the adoption of the NIS2 directive will help the operators keep up with similar cybersecurity regulations around the world. For instance, Australia reformed the Critical Infrastructure Protection Act in 2022 to address the evolving cyber threat landscape. The UK, while no longer part of the EU, is in the process of revising the cybersecurity regulation for critical infrastructure operators in line with NIS2.

EOS Perspective

Upon implementation of NIS2, maritime operators will need to invest in more effective cybersecurity requirements, potentially increasing costs in the short term. Despite this, the increased investment will result in a more secure and resilient industry in the long run, and companies that are able to invest heavily in security are going to gain a competitive advantage over those that are not able to do so.

Digitization and connected technology in the maritime sector are evolving faster than its ability to regulate it. Hence, the maritime sector should view NIS2 as just another measure to elevate the cybersecurity framework. Companies need to be agile and flexible to adapt to the evolving cyber threat landscape.

17/08/2023by EOS Intelligence EOS Intelligence No Comments

New EU Pharma Legislation: Is It a Win-win for All Stakeholders?

374views

The revision of the EU pharmaceutical legislation represents a major achievement for the pharmaceutical sector within the European Health Union. The European Health Union, established in 2020 as a collaboration among EU member states, aims to effectively respond to health crises and improve healthcare systems across Europe. This revision provides an opportunity for the pharmaceutical sector to adapt to the demands of the 21st century, enabling greater flexibility and agility within the industry. The updated EU pharmaceutical legislation places a strong emphasis on patient-centered care, fostering innovation, and enhancing the competitiveness of the industry.

Limited market exclusivity to offer indirect opportunities to generic drug manufacturers

The COVID-19 crisis in 2020 raised a significant concern related to the accessibility and availability of life-saving medicines. The pandemic highlighted the significance of establishing effective incentives for the production of medicines to address medical needs during health emergencies.

Therefore, revised EU pharmaceutical legislation includes several rules and regulations to incentivize pharmaceutical companies to create a single market for medicines to ensure equal access to affordable and effective medicines across the EU. This is to be achieved through reducing the administrative burden by shortening authorization time, the duration required to review and grant approval for a new medicine, ensuring efficacy, safety, quality, and regulatory requirements. For example, the EU Commission will have 46 days instead of 67 days for authorization of medicine, whereas EMA (European Medicine Agency) will have 180 days instead of 240 days for the assessment of new medicine.

The new directive incentives are expected to help in improving access to medicines in all member states, in developing medicines for unmet medical needs, and in conducting comparative clinical trials (CCT). Comparative Clinical Trials are clinical research studies aimed at comparing the efficacy and safety of distinct medical treatments. Such trials usually entail two or more groups of participants, each receiving a different treatment in order to ascertain the more effective, safer treatment that offers better outcomes for a specific condition.

The legislation also focuses on maintaining the availability of generic drugs and biosimilars to help countries with more affordable and accessible medicines across the EU. It also aims to provide enhanced rules for the protection of the environment, such as mandatory ERA (environmental risk assessment) of medicines which focuses on discarding medicines properly by ensuring the minimization of environmental risks that are associated with the manufacturing, use, and disposal of medicine on the EU market, promoting innovation, and tackling antimicrobial resistance (AMR).

The revised pharmaceutical legislation introduces a shortened period of regulatory protection, reducing it from 10 to 8 years, in order to establish a unified market for new medicines. This protection encompasses 6 years of regulatory data protection and 2 years of market protection. Companies can also benefit from an additional 2 years of data protection if they launch their medicine in all 27 EU member states and an extra 6 months of protection if their medicine addresses unmet medical needs or undergoes comparative clinical trials.

The revised EU pharma legislation also includes provisions for 2 years of market exclusivity for pediatric medicines and 10 years of market exclusivity for orphan drugs. The limited market exclusivity for branded drug manufacturers is expected to give the generic medicine makers more opportunities for production, hence improving the affordability and accessibility of medicines across the EU.

New EU Pharma Legislation: Is It a Win-win for All Stakeholders by EOS Intelligence

Assessing changes for the European Medicines Agency

The EMA is responsible for the evaluation and approval of new medicines while monitoring the safety and efficacy of the medicine. The revised EU pharmaceutical legislation has bestowed significant responsibilities upon the EMA. These responsibilities encompass expediting data assessments and providing enhanced scientific advice to pharmaceutical companies. The legislation has both positive and negative impact on the EMA.

On the positive side, it aims to harmonize regulatory processes across member states, leading to a more streamlined and efficient system. This is expected to improve the agency’s ability to assess medicines promptly, facilitating faster access to innovative treatments. Additionally, the legislation encourages collaboration among regulatory authorities and promotes international partnerships, which strengthen the EMA’s regulatory capacity and scientific expertise. Further, the new regime is likely to foster EMA to prepare a list of critical medicines and ensure their availability during shortages.

The challenges that EMA might face if the new pharma legislation is passed include increased workload and resource requirements, which may necessitate additional staff, expertise, and funding. Complex areas such as pricing, pharmacovigilance, data transparency, and reimbursement could pose difficulties, potentially leading to delays and discrepancies.

Balancing affordability and access to medicines while incentivizing pharmaceutical companies’ investment in R&D under strict regulations, health technology assessments, and data transparency could be a challenge. EMA might face obstacles in training, resource allocation, and maintaining regulatory consistency. Both positive and negative impact should be considered while implementing the revised legislation.

Overriding drug patents could ensure supply, albeit with challenges

Overriding a drug patent is a legal mechanism allowing governments to bypass the patent protection of medicines and medical technology during emergency situations.

Although it poses challenges to the original patent holder company, including implications on revenue streams, investments, and profitability, it enables the granting of compulsory licenses to generic drug manufacturers, which increases production and reduces prices, particularly during health emergencies, while still considering the rights and interest of patent holders (through compensation for the use of their invention during the emergency period). It also encourages voluntary licensing that allows generic manufacturers to produce and sell products with the patent holder’s permission while respecting patent rights, instead of overriding the patent as it is in compulsory licensing.

Amidst concerns pertaining to intellectual property (IP) rights and the fact that this move might potentially discourage pharma companies from investing in R&D initiatives, the revised EU pharmaceutical legislation proposes overriding drug patents, as it would enhance the availability of affordable and cost-effective medicines throughout the EU. The production of generic drugs and biosimilars is likely to help increase market competition, drive innovation, and introduce improved treatments across the EU, maintaining a competitive edge.

Overriding drug patents might also have ramifications on international trade and relationships, leading to disputes and strained ties between countries. While considering these laws, policymakers need to exercise caution to ensure both accessibility of medicines and adequate investments in R&D.

New EU pharma legislation to benefit Eastern European countries

The difference in access to medicines between Eastern and Western European countries is evident from the fact that from 2015 to 2017, EMA approved 104, 102, and 101 medicines for Germany, Austria, and Denmark, respectively, compared to only 24 in Poland, 16 in Lithuania, and 11 in Latvia. These distinct differences in the availability of medicines between Eastern and Western European countries could be attributed to factors such as stronger healthcare systems in the Western region, higher healthcare budgets, and a greater ability to negotiate pricing and reimbursement agreements with pharmaceutical companies.

Western European countries have relatively better funded and more advanced healthcare infrastructure, including clinics, hospitals, and specialized healthcare services compared to Eastern European countries. Western European countries have a larger capacity to invest in research and development and contribute to the development of new medicines.

Moreover, differences in national healthcare policies contribute to the variation in pharmaceutical benefits and outcomes. The presence of a robust and extensive pharmaceutical manufacturing industry in Western European countries allows for faster production and distribution of medical supplies. Consequently, Western European countries generally have better access to medicines and medical supplies compared to Eastern European countries.

The new EU pharmaceutical legislation helps Eastern European countries by reducing the exclusivity period of newly introduced drugs. This measure can prevent branded drug manufacturers from selling drugs exclusively to more affluent countries.

Moreover, according to experts, branded drug manufacturers are likely to only theoretically benefit from a competition-free market for 12 years because the majority of medicines launched by them are unlikely to meet all the new criteria in order to be granted this extended competition-free market access. This might compel branded medicine manufacturers to expand their sales base and sell in Eastern European countries as well to maximize their revenues.

New EU pharma legislation to spur a changing investment landscape

With the approval of new EU pharmaceutical legislation, it is expected that investment plans within the pharmaceutical sector will undergo significant changes. The regulatory changes, which aim to reduce the time and administration burden, could help in attracting lucrative investments by offering faster returns for pharmaceutical companies.

The new legislation can be expected to bring more investments in the R&D and manufacturing sectors by addressing critical healthcare challenges. Furthermore, the availability of generic and biosimilars would also help by creating opportunities for investment in the production/manufacturing of cost-effective medicines.

Moreover, enhancement in transparency and data sharing can also lead to increased collaboration and partnerships in R&D, attracting investments from the public and private sectors in the medical space.

However, investment plans could vary depending upon various factors such as intellectual property rights, market dynamics, competitive landscape, etc. Pharmaceutical companies need to assess new legislation in order to adjust their investment strategies to navigate potential challenges.

EOS Perspective

Analyzing the winning stakeholders of the revised EU pharma legislation could be challenging at this point in time owing to the fact that the new regime focuses on addressing issues of affordability and innovation across the EU which tend to be contradicting. These aims are to be achieved by incentivizing R&D and manufacturing sectors, enhancing market competition, and promoting collaboration.

It cannot be denied that there will be several challenges while enforcing these changes. A few of these challenges include maintaining intellectual property rights, marrying affordability with innovation, and addressing the specific needs of various patients in different countries. Specific resources and coordination will be required to overcome these hurdles. As a result, the success or failure of the EU pharmaceutical legislation for stakeholders will depend on the legislation’s actual implementation, adaptation to changing market dynamics, stakeholder engagement, as well as whether the balance between accessibility, affordability, and innovation while maintaining competitiveness is achieved and maintained in the long term.

Microsoft-Activision Blizzard Deal – A Potential Game-changer in the Gaming Industry by EOS Intelligence

11/07/2023by EOS Intelligence EOS Intelligence No Comments

Commentary: Microsoft-Activision Blizzard Deal – A Potential Game-changer in the Gaming Industry

493views

Gaming industry is booming, with a significant surge in growth occurring during the 2020-2021 pandemic, when millions of people turned to games during lockdowns. The industry is currently worth US$184 billion and is expected to reach over US$200 billion by 2025.

The market is very competitive, with a need for considerable investment and time for publishers to create successful games and for companies to develop consoles that offer advanced features and an attractive catalog of games. This is pushing players towards increased consolidation to achieve economies of scale and lower risks and to strengthen their position in the market. More than 650 gaming M&A or investment deals were announced or closed in the first six months of 2022.

Out of the numerous M&As that have recently occurred in the industry, Microsoft’s acquisition of Activision Blizzard, the maker of the world’s most popular games such as Call of Duty, Warcraft, and Candy Crush, is anticipated to make a substantial impact on the market. Microsoft announced its intent to acquire Activision for US$68.7 billion in January 2022, which was going to be the largest acquisition in the gaming industry to date. The consolidation of two strong players in the industry – Microsoft being the manufacturer of the Xbox gaming console and Activision being the publisher of many popular games – could offer users a large catalog of games and improve gaming experience and cloud-gaming services. However, it has also raised a concern that this could suppress the competition in the market of consoles, gaming subscriptions, and cloud-gaming. Many regulators across the world have blocked the deal, including the US Federal Trade Commission (FTC) and the UK’s Competition and Markets Authority (CMA). Microsoft is currently trying to get approval from the regulators.

How does the deal benefit Microsoft?

If the deal gets approved, it will turn Microsoft into one of the top three video game publishers, right behind its rival Sony. This would enhance Microsoft’s games catalog with Activision’s games, making Xbox’s choice more attractive than Sony’s PlayStation. Microsoft would also be able to enter the mobile gaming market with Activision’s mobile games, such as Candy Crush and King. This opens a large market segment, previously unaddressed by Microsoft, a segment that accounts for 50% of the total gaming market. Microsoft is planning to open Xbox’s mobile game store to compete with Apple and Google game stores.

As users increasingly prefer gaming subscriptions and cloud gaming services over physical DVDs, it gives an added advantage for Microsoft to own some of the most popular gaming titles and offer attractive subscriptions on its platform. Currently, Microsoft holds 60-70% of the global cloud gaming services market and could further squeeze into the shares of other companies, such as Google, to dominate the market.

The company would also be able to venture into metaverse and Non-Fungible Token (NFT) games using technological and newly acquired game development capabilities.

What does this deal mean for gamers?

The Xbox Game Pass subscribers would benefit from the added list of Activision Blizzard games, which would be incorporated into the existing catalog. However, it is unclear whether Microsoft could make future games developed by Activision unavailable on other consoles, such as Sony PlayStation and Nintendo Switch. There is also a possibility for Microsoft to increase the subscription prices if gamers are highly reliant on Xbox-exclusive games.

Cloud gaming technologies are likely to improve in the future to overcome high latency and lost frames issues faced currently. However, if Microsoft dominates the cloud gaming space, it may reduce the gaming choices for gamers.

What are the concerns over the deal?

The major concern put forth by the regulators is whether the deal could negatively impact the competitive landscape of the market. For example, Sony currently owns 21 in-house game studios, and Microsoft owns 23. If Microsoft manages to get the deal, the company will have 30 in-house game studios, making Microsoft’s Xbox a much better choice and also giving the power to decide where these games are to be played. If Microsoft makes Activision’s future games exclusive on its platforms, it will dominate the console, mobile, and cloud platforms, killing the competition. This can discourage competitors from developing high-quality games. It can also enable Microsoft to decide to reduce the quality of its games or increase the prices when it dominates the market. Even if the company makes these games available on other platforms, competitors fear that the company may offer low-quality versions or remove their marketing rights or support for other console features.

The biggest concern is over one particular game – Activision’s Call of Duty, the most-played video game in the world. Microsoft has already agreed to offer a 10-year licensing deal to console manufacturer Nintendo, however, Sony has refused to accept the offer. When Microsoft purchased Bethesda game studio in 2021, the company made its highly anticipated sci-fi game Starfield into an X-box and PC exclusive. This is one of the reasons why regulators are concerned about Microsoft’s promises to make its games available on other platforms.

The regulators also raised concerns about how the company could completely sabotage the cloud-gaming market by withholding Activision’s games from rival cloud-gaming services.

Status of the lawsuits

Microsoft is yet to receive approval from the US FTC and UK CMA. The company attempted to convince the CMA by entering into agreements with cloud gaming competitors to provide access to Xbox games. CMA remains unconvinced, which appears to be a major block for this deal. However, the company’s agreements with Nintendo and NVIDIA on providing a 10-year licensing deal for the Call of Duty game have convinced the EU regulators, and the company has won the EU antitrust approval. Regulators in Saudi Arabia, Brazil, Chile, Serbia, Japan, and South Africa have also approved the deal.

The case filed by FTC is still in the document discovery stage, and an evidentiary hearing is scheduled for August 2023. Even though the company has won FTC lawsuits before, it is to be seen if it can win the approval for this massive acquisition deal.

EOS Perspective

Considering how Nintendo managed to acquire a 30% market share in the video gaming console industry by owning just 2 studios compared to Microsoft’s 25% share with 23 owned studios, it might not be very concerning that Microsoft owning 7 more studios through the Activision deal could sabotage the competition in the market. The deal can make the rivals more competitive to develop better console generations and games.

However, it can be anticipated that Sony might lose some of its market share to Microsoft right after the deal. It can also affect Sony’s profit if the company has to take paid licenses of games owned by Microsoft. However, on the other hand, if Microsoft goes against its promises and makes the games exclusive on its platforms or does not support the other platforms’ gaming experience, it could seriously damage the competitors’ businesses. Looking at the brighter side, the marriage between two superpowers in the gaming industry could significantly transform the gaming experience for the users, open new possibilities such as Xbox mobile-game subscriptions or metaverse games, or improve cloud-gaming services.

19/08/2022by EOS Intelligence EOS Intelligence No Comments

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

2kviews

South Korea is the 9^th 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.

27/04/2022by EOS Intelligence EOS Intelligence No Comments

Morocco’s Auto Industry Is in Full Gear

3.5kviews

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.

20/01/2022by EOS Intelligence EOS Intelligence No Comments

Clean Beauty: Next Stop – China

590views

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.

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.

Who We Are

Connect With Us

Work With EOS

Who We Are

Connect With Us

Work With EOS

Healthcare administrative costs hold the lion’s share of total healthcare expenditure

Healthcare services costs, including physicians’ salaries, empty patients’ pockets

Skyrocketing prescription drug prices further inflate healthcare costs

Chronic diseases add fuel to the fire of escalating healthcare costs

Expanding geriatric population contributes to rising healthcare costs

Greed over welfare

EOS Perspective

Factors responsible for medicine shortages in the EU

Economic factors

Production and supply chain factors

Reactions from various stakeholders in the EU pharma market

EOS Perspective

Companies may feel burdened by strict NIS2 requirements

While NIS2 adoption may seem taxing, benefits are likely to follow

EOS Perspective

Limited market exclusivity to offer indirect opportunities to generic drug manufacturers

Assessing changes for the European Medicines Agency

Overriding drug patents could ensure supply, albeit with challenges

New EU pharma legislation to benefit Eastern European countries

New EU pharma legislation to spur a changing investment landscape

EOS Perspective

How does the deal benefit Microsoft?

What does this deal mean for gamers?

What are the concerns over the deal?

Status of the lawsuits

EOS Perspective

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

New initiatives: customized cosmetics regulations and product refills

International brands and PE firms investing in Korean beauty brands

Not everything is as ideal as it seems

EOS Perspective

Investments

Government initiative

EOS Perspective

China’s new cosmetic regulations easing entry for imported products

Companies responding to the new regulations

Despite new regulations, challenges remain

EOS Perspective