The European Union’s proposals to strengthen the pharmaceutical ecosystem are not ambitious enough to address health inequities

The recent meeting of the European Union’s (EU) Employment, Social Policy, Health and Consumer Affairs Council on 13 June, was an opportunity for Health Ministers make proposals to  strengthen the pharmaceutical ecosystem in support of competitiveness and equitable access to medicines. 

The discussion resulted from the Commission’s recently released proposal for the revision of pharmaceutical legislation.

The COVID-19 crisis showed that there are many issues to be resolved regarding the accessibility and availability of lifesaving medicines and the need for effective incentives to produce medicines that truly respond to medical needs, particularly during global public health emergencies.

While it is challenging to improve the pharmaceutical legislation and address the concerns of different stakeholders,  we urge the EU to do better. 

The pharmaceutical package should take into account the impact of quality service provision, make clear the most suitable drugs for particular patients, and enhance inter-agency cooperation – not only at EU-national level, but also within the EU (for example, Directorates General for Trade, International Partnerships, Health Emergency Preparedness and Response Authority, European Centre for Disease Prevention and Control, European Health and Digital Executive Agency).

New measures should be created to control and survey the modification of medicines that may extend patent protection inappropriately. Pharmaceutical companies must prove that the modifications they make are bringing additional value to the patients versus simply extending patents to prevent access to cheaper versions of their drugs.

We also recommend more transparency in R&D-related costs to bring benefits for health use and imply innovation, allowing a better understanding of the medicines landscape and tracking needs overall. 

The pay and bonuses of pharmaceutical company CEOs should also be directly linked to the impact on positive public health outcomes and access to medicines, especially in developing countries.

Pandemic products as public good

 Recognizing pandemic-related products as a public good during health emergencies and limiting the profit margins is the logical step to improve responses to crises.  It should become binding, not only in the pharmaceutical package, but also in the future pandemic accord.

In addition, the legislation under negotiation should bring more equity among EU member states by harmonizing marketing approvals and distribution of new products in all national markets. 

Finding the balance between national, private, and patients’ interests is hard, and taking sides may be inevitable. We strongly believe that the EU must, first and foremost, support the population, the community, and the patients – all who bear the brunt of a lack of access to affordable medicines.

The revision of the pharmaceutical legislation is also an opportunity to reflect on where we want our health systems to be in the future and the kind of care we can provide to people. 

Do we want to continue to incentivise the high salaries and profits for big pharmaceutical companies, with $19,2 million pay packages, while many struggle to access basic medicines and other health commodities? 

Can we allow companies to make $5.6 billion in sales while still in the pandemic period, while countries are operating in emergency mode and struggling to keep their respective responses going?

Emerging divisions between EU members

Since the publication of the revised pharmaceutical legislation on 26 April,  divisions between member states are emerging. 

One group (Austria, Estonia, Hungary, the Netherlands, Poland, Slovakia) is pushing for more flexibility for the generic market and requiring new products to respond to unmet medical needs allowing profits from incentives. 

The other group (Germany, Italy, Denmark) is pushing for more protection of private industries, including a more predictable regulatory framework, voluntary commitments for companies, and the safeguarding of intellectual property rights.

The revision of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is also closely linked with equal access to medicines and the revision of pharmaceutical legislation. 

The EU is strongly promoting its own vision of voluntary and compulsory licensing, leading to complicated negotiations at the WTO. Several patient advocacy associations have pointed to the need for revisions to TRIPS Agreement since voluntary licenses are often difficult to implement, have limited scope of distribution, exclude many middle-income countries, and sometimes do not even allow the sales of active pharmaceutical ingredients. 

As authorities leave the market unregulated, the profit-seeking nature of private companies often makes it  difficult access to lifesaving medicines, including for treatable conditions such as HIV and hepatitis C.

Patent evergreening, whereby pharmaceutical companies are able to extend patents by making small changes to the formulations that do not constitute a major innovation, and re-patenting them as new and improved drugs, also needs to be addressed by the EU.

 Patent evergreening creates barriers to affordable, generic medicines and keeps them from reaching low- and middle-income countries. It also carries societal costs and often deviates research from truly necessary medical needs, keeping costs higher and undermining access.

There is a danger that even the innovative incentives to produce medicines responding to unmet medical needs, such as exclusivity vouchers, risk the distortion and monopolization of markets of public interest. One year of market exclusivity is estimated to cost  around €500 million by the European Commission.

We echo the sentiments of other like-minded advocates like Dimitri Eynikel of Médecins Sans Frontières who states, “We urge EU member states and the European Parliament to not forsake this opportunity to legally safeguard public health interests and remain vigilant up until this new proposal is adopted as legislation: there must be no watering down of the provisions on transparency and compulsory licenses, and if access to affordable medicines in the EU is a priority, any inclusion of transferable exclusivity vouchers should be seriously challenged.” 

Only by taking responsibility and accepting accountability for people’s health now can the EU better prepare for future health crises and establish an innovative, fair, and inclusive health system that works for all.

AIDS Healthcare Foundation Europe is the European branch of world’s largest non-governmental HIV service provider, AIDS Healthcare Foundation (AHF). AHF Europe is active in nine European countries: Estonia, Georgia, Lithuania, Poland, Ukraine, UK, the Netherlands, Greece and Portugal;  supporting HIV/AIDS prevention, testing and treatment services. AHF Europe advocates for inclusive health care services, equal access to medicine, comprehensive prevention initiatives and multisectoral approach to health at national, regional and international levels.  For further information, contact Indre Karciauskaite, Europe Policy Director, indre.karciauskaite@ahf.org 

Image Credits: Carl Campbell/ Unsplash, Wikimedia Commons: Alteo31300.