In the Leadup to EU Elections, Biosimilar and Generics Group Calls for Sustainable Market Policies

Kelly Davio

European elections will take place later this month, allowing EU citizens to select their representatives in the European Parliament. The elections, being held for the first time in 5 years, are particularly significant to the healthcare sector as European stakeholders seek to reduce disparities in access to care, guard against drug shortages, and ensure a sustainable market for pharmaceuticals.

European elections will take place later this month, allowing EU citizens to select their representatives in the European Parliament. The elections, being held for the first time in 5 years, are particularly significant to the healthcare sector as European stakeholders seek to reduce disparities in access to care, guard against drug shortages, and ensure a sustainable market for pharmaceuticals.

In the leadup to the elections, Medicines for Europe (MFE), which represents Europe’s biosimilar and generic drug makers, has issued an election manifesto that centers on what it terms 4 pillars: equitable access to drugs for all Europeans, a responsive regulatory framework, European leadership in manufacturing of medicines, and empowerment of the healthcare community.

According to the manifesto, titled “Together for Health,” access to therapy currently depends on the wealth of the area in which a patient resides. In order to increase access, the European Union must embrace generics and biosimilars in their healthcare policies, and it must ensure that there is effective competition in the off-patent sector. MFE also calls on the EU to develop sustainable market policies to help ensure long-term product availability.

The manifesto also explains that it sees the EU regulatory framework as largely fragmented, and it calls for greater coherence and fitness for purpose. MFE also renewed calls for a reduction in unnecessary tests and trials, and it said that a global agenda for regulatory harmonization must be shaped.

With respect to drug manufacturing, MFE says the Europe must promote the secure supply of products via industrial strategy and must create a level playing field between EU and non-EU nations. Among key features of such a strategy will be the development of incentives for manufacturing products in the EU to secure supply and reduce shortage risk.

Finally, the EU must promote sustainability of its systems, promoting modern and efficient digitization of systems to help better connect the healthcare community and promote better decision-making.

In a statement on the launch of the manifesto, Medicines for Europe’s director general, Adrian van den Hoven, said “the EU elections are an opportunity to improve to healthcare across Europe. The [European Union] can do more to ensure equitable access to medicines for patients for all Europeans. Our industry is ready to engage with the [European Union], national governments, and stakeholders to make this happen.”

In its own manifesto, the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents innovator drug makers, called on Europe to make similar commitments to improved patient access and also highlighted the need for a coalition on vaccination and the dissemination of objective, transparent information on vaccines. However, EFPIA also called for fast-tracking of breakthrough drugs, new incentives for drugs that address unmet needs, a framework for public and private partnerships, and adoption of new clinical trial designs.