Tuesday, April 16, 2024

Overhauling Europe’s Pharmaceutical Framework: A Critical Assessment of the General Pharmaceutical Legislation Revision

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In a historic move, Europe is overhauling its pharmaceutical framework for the first time in two decades. The revision of the General Pharmaceutical Legislation (GPL) is not merely a procedural update; it represents a once-in-a-generation opportunity to reshape the pharmaceutical landscape. As the European Union Institutions engage with stakeholders on these proposed changes, it’s crucial to contemplate the far-reaching implications for patients, the region, and scientific advancement.

Increasingly, there’s a realization that investments in healthcare and manufacturing yield enduring benefits for patients, societies, and economies. The European Commission’s efforts to streamline procedures at the European Medicines Agency are commendable, aiming to enhance regulatory predictability for applicants. However, certain aspects of the GPL demand more attention, as they could have adverse consequences.

For instance, a recent study commissioned by EFPIA from Dolon highlights that proposed reductions in regulatory data protection could deter companies from investing in groundbreaking medicines by a significant 55% over the next 15 years in Europe. Furthermore, this could exacerbate Europe’s innovation decline relative to global peers like the USA, China, and Japan, potentially leading to:

  • A one-third reduction in Europe’s share of global R&D investment by 2040, plummeting from 32% to 21%.
  • The abandonment of one in five medicines currently in development (22%), rendering them economically unviable in Europe.
  • A loss of 16 million years of life due to increased mortality and premature deaths across the EU.

Without necessary revisions, Europe might find itself dependent on other regions for medical innovation and supplies, with patients waiting longer for cutting-edge treatments. Investing in healthcare is not a mere cost; it’s an investment in EU public health and the well-being of its citizens.

The Impact of EU Orphan Medicines Regulation on Rare Disease Research

One area where EU regulation has undeniably succeeded is the Orphan Medicines Product Regulation from the early 2000s, which incentivized research targeting rare diseases. This initiative led to a surge in scientific activity and innovative treatments for rare diseases, with the number of EU-approved orphan medicines soaring from single digits to over 230. However, the European Commission’s provisional criteria for defining high unmet medical needs within rare diseases have raised concerns.

The ambiguity of these criteria creates uncertainty for companies like Amgen, potentially deterring investments in innovative research for rare diseases. This could negatively impact the development of 45 rare disease products, resulting in a 12% decline in innovation. Such consequences could deprive around 1.5 million individuals living with rare diseases of access to novel treatment options.

Pharmaceutical Framework

The Vital Role of Supportive Pharmaceutical Frameworks in European Biotech

Small and medium enterprises, particularly Europe’s biotech sector, are likely to be disproportionately affected due to the unpredictability and less favorable R&D conditions arising from the General Pharmaceutical Legislation proposals. Amgen, a prominent biotechnology company, serves as a testament to the importance of a supportive and predictable framework for innovation. Originating as a small start-up in 1980, Amgen has evolved into a global leader in biotechnology, delivering groundbreaking medicines to millions of patients worldwide. Amgen’s success underscores the significance of fostering an environment that encourages investment and innovation in healthcare.

As Europe endeavors to fulfill the General Pharmaceutical Legislation’s core purpose, Members of the Parliament and Council mustn’t compromise competitiveness or impede research, development, manufacturing, and delivery of new treatments for patients. Amgen reaffirms its commitment to collaborating with stakeholders to champion policies that prioritize patients and innovation, thus bolstering the EU’s role as a driving force in medical progress.


Resource: EFPIA, December 12, 2023

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