Off-patent medicines could strengthen Europe’s healthcare systems

At its annual conference in Spain, Medicines for Europe shared recommendations for greater use of off-patent medicines such as biosimilars and generics to ensure medicines remain available to patients in the face of global events and supply chain issues.

Speakers made recommendations during a Medicines for Europe presentation at the organization’s annual conference Reform health system policy and encourage the use of off-patent medicines such as biosimilars and generics to strengthen European healthcare systems.

The conference lasted from June 29 to July 1, 2022 and was held in Sitges, Barcelona, ​​Spain. Along with the presentation, Medicines for Europe published a report It outlined how market policies could be optimized to ensure medicines are accessible and available within European healthcare systems.

According to the organization, off-patent medicines account for 70% of medicines dispensed across Europe and are typically used to treat cancer, autoimmune, respiratory and cardiovascular diseases.

Speakers highlighted the additional burdens healthcare systems have had to bear during the COVID-19 pandemic, the war in Ukraine, high rates of inflation and challenges in the drug and active pharmaceutical ingredient (API) supply chain.

“We have to act concretely [European Union] and at Member State level to promote research, development and production of generics and biosimilars in Europe. This should also be reflected in any policy action building on the experience of COVID-19, including the outcomes of the EU Structured Dialogue on the Security of Supply of Medicines, as off-patent medicines played a key role, particularly in the first outbreak of the pandemic our patients,” said Dolors Montserrat, Member of the European Parliament, in a expression.

Medicines for Europe said off-patent medicines are a clear part of the solution to ensure healthcare systems across Europe are adequately resourced to provide care in the face of global disruptive events. The organizations said further policy reforms in favor of off-patent medicines are needed to strengthen health systems in the region.

“We need the clear support of legislators, governments and drug manufacturers to ensure that our active ingredients, manufactured with the highest quality and safety standards in the world, continue to provide the best health for European patients. We can remain strong and competitive with flexible regulations, recovery funds that are genuinely available, reference prices adjusted to manufacturing costs and a determined promotion of European production,” argued Jordi Valls, Vice President of Afaquim.

Medicines for Europe lists 4 key actions the European Union could take to overhaul current EU medicines legislation:

  • Promote the use of generics, biosimilars and value-added medicines to improve access to medicines and ensure budgetary sustainability
  • Support the off-patent drug industry’s response to inflation by changing drug sourcing policies and protecting the pharmaceutical manufacturing sector in contingency plans
  • Advocate for durable supply chains and manufacturing of medicines by enabling access to EU funds
  • Critical assessment of pharmaceutical intellectual property (IP) infrastructure, taking steps to mitigate abuse issues and fully supporting the entry into force of the manufacturer SPC waiver

Margaritis Schinas, Vice-President of the European Commission for Promoting Our European Way of Life, summed up the presentation: “We are reviewing medicines legislation at EU level. The goals are clear: to make medicines affordable for all and to ensure that the European industry remains an innovative world leader. These are not contradictory goals, on the contrary, both are possible and we should make it happen.”

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