Medicines for Europe Recommends Off-Patent Drugs to Strengthen European Health Systems

During a session at the Medicines for Europe annual conference, the organization recommended policy reforms that would favor the use of off-patent medications, such as biosimilars and generics, to strengthen European health systems.

The conference lasted from June 29 through July 1, 2022 and took place at the Dolce Sitges Hotel in Sitges, Barcelona, Spain. Along with the presentation, Medicines for Europe shared a report aimed at optimizing market policies to ensure a secure supply of medicines within European health systems.

The speakers mentioned the extra burden that health systems have had to face in light of the COVID-19 pandemic, the war in Ukraine, and high inflation rates, all of which have challenged the supply chain for essential medications.

Off-patent medicines, including biosimilar and generic drugs, account for 70% of medications dispensed across Europe. Off-patent drugs are typically used to treat patients with different types of cancer, autoimmune conditions, respiratory illnesses, and cardiovascular disease. According to a statement from Medicines for Europe, the medicines are a clear part of the solution to ensure the health systems in Europe are more resilient, and policy reforms that favor off-patent medications are needed to strengthen those systems.

“The role of the EU in health policy took on a new life during the pandemic and should continue to do so if we want our health systems to be resilient. Europeans now expect strong EU leadership on health policy and our industry, as the biggest supplier of medicines to patients in Europe, is ready to play its part…. Our recommendations will ensure that medicines remain available, affordable, and accessible for patients, and also reduce the risk of medicines shortages and increase European strategic autonomy,” said Elisabeth Stampa, president of Medicines for Europe and CEO of Medichem, at the conference.

Medicines for Europe laid out 4 ways that the European Union must do when revising EU pharmaceutical legislation:

• Encourage the use of generic, biosimilar, and value-added medicines to increase access to medications and ensure budgetary sustainability
• Support the off-patent medicines industry response to inflation by altering procurement guidelines for drugs and safeguarding the pharmaceutical manufacturing sector in emergency response plans
• Commit to durable supply chains and manufacturing for medications by enabling access to EU funds
• Critically assess the intellectual property (IP) infrastructure for pharmaceuticals, take action to mitigate abuse issues, and fully support the entry into force of the supplementary protection certificates manufacturing waiver

“We are revising the pharmaceutical legislation at EU level. The objectives are clear: having medicines at affordable conditions for all, and ensuring European industry remains an innovative world leader. These are not antagonistic objectives, on the contrary, both are possible, and we should make them a reality,” commented Margaritis Schinas, vice president of the European Commission for Promoting our European way of life.

In addition to the welcome session, Medicines for Europe hosted several discussion groups, including one on how the future of the biosimilar and generics industry could involve a shift from an IP approach to a more holistic one, another on creating a sustainable pharmaceutical ecosystem in the European Union, and one on using concerted action to address medicine shortages.

Additionally, the final panel of the conference featured a discussion on national strategies and practices influencing the sustainability of the European biosimilar market and patient access to biologics. The expert panelists also took a look at how the industry is expected to evolve by 2035 and how to Europe can plan for these changes.