The European framework for intellectual property rights for biological medicines

Category: Original Research
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Keywords: biological medicines, European intellectual property rights, market access, pricing, R & D

Author byline as per print journal:
Josette Sciberras, MBA, MA Bioethics, BPharm (Hons); Raymond Zammit, SThD; Patricia Vella Bonanno, PhD

Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and its impact on accessibility of biological medicines and sets recommendations.
Methods: A non-systematic literature review on IP for biological medicines was conducted. Data on authorizations and patent and exclusivity expiry dates of biological medicines obtained from the European Medicines Agency’s (EMA) website and literature was analyzed quantitatively and qualitatively.
Results: The analysis showed that as of end July 2021, 1,238 medicines were authorized in Europe, of which 332 (26.8%) were biological medicines. Only 55 were biosimilars for 17 unique biologicals. There is an increasing trend in biological authorizations but significant delays in submission of applications for marketing authorization of biosimilars, with no significant differences in the time for assessment for marketing authorization between originator biologicals and biosimilars. The more recent biosimilars submitted applications for authorization prior to patent and exclusivity expiry. COVID vaccines confirmed the impact of knowledge transfer on accessibility, especially when linked to joint procurement.
Discussion: IP protects originator products and impacts the development of biosimilars. Strategies to improve competition in the EU biological market are discussed. Pricing policies alone do not increase biosimilar uptake since patients are switched to second generation products. Evergreening strategies might be abusing the IP framework, and together with trade secrets and disproportionate prices compared to R & D and manufacturing costs lead to an imbalance between market access and innovation.
Conclusion: The European Pharmaceutical Strategy should focus on IP initiatives that support earlier authorization of biosimilars of new biologicals. Recommendations include knowledge sharing, simplification of the regulatory framework and transparency of prices and R & D costs.

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.

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