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Institute Report
Protection Expiry and Journey into the Market
Pharmaceutical products in Europe
Sep 28, 2022
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Web Summary

The increasing demands of an aging population, the complexity of new medical innovations, and the macroeconomic headwinds facing Europe require effective competition to generate savings and increase patient access, while positioning the European market as an attractive and innovative region for investment. Therefore, the intellectual property rights for pharmaceuticals that protect medicines from competition, and later permit competition, are important to understand, especially as regulations and practices evolve.

In 2008, a study entitled ‘Factors affecting Generic Entry in Europe’ was produced by CRA International (CRA) and IMS Consulting (IMS) to investigate the factors that affect generic entry when pharmaceutical products lose protection in Europe. Now, 15 years later, a new report has been commissioned to assess the current situation.

The market has changed significantly since 2008, with implementation of new regulations, new countries joining the EU, and the increased importance of biologics and specialty medicines. Many of the original findings remain relevant, however results around the importance of originator-molecule access, challenges to biologic competition, and the time to competitor entry are novel. This research aims to provide all stakeholders with a robust evidence base upon which policy can be developed.

This report examines the cohort of medicines that have lost protection across the past six years. The period for assessment (2016–2021) has been chosen to reflect 10 years since the alignment of the regulatory data protection (RDP) rules in Europe and creates more reliable results as more time has passed since markets entered the European Union.

Key Findings

  • The 118 medicines that lost protection within this study are innovative therapies used by physicians and patients across the EU, which represented ~13% of the total European pharmaceutical expenditure at their peak
  • The total market value of these molecules and their competitors in the past six years has been more than €100 billion
  • This cumulative amount represents approximately 10% of the total pharmaceutical expenditure in Europe in the same period
  • For products losing market protection in 2016–21, a large portion of fixed combinations were indicated for cardiovascular indications
  • Looking forward, a greater proportion of expiries for HIV combinations in the medium-term and oncology fixed-dose combinations in the long-term could be impacted
  • The risk of adjusting a single form of protection is that the incentive to innovate in specific therapy areas could be negatively impacted, or the importance of one form of protection becomes increasingly important to have
  • The implication of this non-uniform distribution of protection type is that changes to a single policy could have a disproportionate impact on a specific product group, or manufacturer
  • In Europe, 77% of no longer protected molecules have competition
  • Comparing this to the global market, a further 8% of products have generic or biosimilar competition
  • The remaining 15% of molecules either have competitors in early-stage development or no competitors being developed
  • These products represent less than 3% of the total loss of protection opportunity in Europe
  • Medicines with approved competition in EU countries are mostly recombinant hormones or recombinant enzymes that have very limited revenue, especially in the U.S., which has significant weight in investment decisions globally
  • Those that have a launched biosimilar are products that generate over €1 billion annually or are biologic products that are often referred to as ‘large molecules’ with peak sales of approximately €300 million, and can support a generic competitor(s)

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