Tuesday, July 16, 2024

Patient Access Enhanced by New Incentive System Across Europe

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Patient access to off-patent medicines, which account for 70% of the medicines dispensed in Europe, is crucially supported by a well-balanced incentives system for pharmaceuticals that ensures their development, production, and supply. These medicines are vital for treating serious conditions such as cancer, autoimmune diseases, and cardiovascular diseases. The revision of European pharmaceutical legislation and the reform of the Supplementary Protection Certificate (SPC) system present a unique opportunity to support the companies that provide the majority of medicines to European patients.

To ensure timely patient access to generic and biosimilar medicines and to encourage more investment in EU manufacturing, several key reforms are necessary:

  • Unified Patent System: There is a need for a truly European patent system that ensures the highest possible quality standards in the interest of patients. This system should reward real innovation over evergreening practices, which are strategies employed by some companies to extend their market exclusivity and delay the entry of cheaper generic medicines.
  • Increased Role of Competition Authorities: Competition authorities must play a more significant role in pharmaceutical policies to ensure that new policies are not misused or abused to delay generic and biosimilar competition at patent or SPC expiry.
  • New Industrial Policy for Generic Medicines Manufacturing: A robust industrial policy is needed for the manufacturing of generic medicines and active pharmaceutical ingredients. This policy should include a broad Bolar exemption, which allows generic manufacturers to conduct the necessary testing and development required to bring their products to market as soon as the original patent expires.

Patient Access and SPC Waiver Discussed at 18th Legal Affairs Conference in Ireland

These policy priorities were the focus of discussions at the 18th Legal Affairs Conference of Medicines for Europe in Ireland. Patent and legal experts, General Counsels, and policymakers also debated the recently published 2024 Industry Report on the SPC manufacturing waiver. The report emphasizes the importance of conducting a thorough review of the SPC manufacturing waiver in 2024, as required by legislation. This review should refine the SPC waiver Regulation and lead to the publication of a European Commission guideline to address frivolous litigation by SPC right holders that delay timely competition and undermine EU manufacturing.

During the conference, General Counsel Sergio Napolitano highlighted the historical context and future implications of the SPC system. “Medicines for Europe was created 30 years ago in response to the Supplementary Protection Certificate (SPC) in Europe, which undermined the competitiveness of the medicine manufacturing industry in Europe,” he said.

“The SPC Manufacturing Waiver, which took 25 years to introduce, needs to be implemented in the spirit of the legislation to exploit all its potential for manufacturing in Europe. In parallel, the EU pharmaceutical legislation reform should ensure the timely launch of generic and biosimilar medicines and introduce a European SPC granting system with the highest quality standards, a clampdown on IP abuses, and a supportive industrial policy for off-patent medicines.”

Patient Access

European Pharmaceutical Reforms to Enhance Patient Access and Industry Competitiveness

The revision of the European pharmaceutical legislation and the SPC system reform represents a critical juncture for the European pharmaceutical industry. By adopting these reforms, Europe can ensure that patients have timely patient access to essential medicines, foster innovation in the pharmaceutical sector, and enhance the competitiveness of European manufacturing. The proposed changes aim to create a more balanced and fair system that prioritizes patient access, supports genuine innovation, and strengthens the European pharmaceutical industry’s global standing.

In conclusion, the future of pharmaceutical manufacturing and patient access in Europe hinges on the successful implementation of these key reforms. By fostering a competitive and innovative environment, Europe can continue to provide high-quality, affordable medicines to its patients while supporting the growth and sustainability of its pharmaceutical industry.


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Resource: Medicines for Europe, June 11, 2024

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