In recent years, Europe’s pharmaceutical sector has faced considerable challenges, resulting in distortions in patient access to new treatments and notable drug shortages. The European Commission proposed and began revising pharmaceutical legislation in the European Union in 2021, aiming for timely and equitable access to safe, effective, and affordable medicines, as well as fostering an innovation-friendly environment for research, development, and manufacturing within Europe. Has this goal been achieved? Currently, endless discussions are ongoing across various levels—committees, proposals, and decisions—that generate confusion and potentially distract from the core objective of the revision.

Specifically, industry insiders highlight that, with the regulations proposed by the Commission, access to new therapies remains problematic, and drug shortages persist at a different level compared to what member states are discussing.

Where do we stand now regarding the revision of pharmaceutical legislation?
The EU pharmaceutical package is presently under negotiation among member states, at the Council level. Poland, which holds the EU presidency until next June, aims to finalize the Council’s position. This will enable the three EU institutions—the European Commission, the European Parliament, and the Council of the European Union—to begin trilogue negotiations on the pharmaceutical package. These negotiations could last from six to nine months or even years.

The Patent Reduction Proposal

Before member states’ proposals, in 2023, the European Commission presented its own legislative initiative. This focused on reducing data protection for medicines from approximately eight years post-approval to six years. This move effectively shortens patent protection and accelerates the generation of generics compared to current timelines. The Commission argues that this will increase competition, as shorter data protection periods will allow other companies to enter the market and produce generics, ensuring market sufficiency.

However, Athena Giannoutsou, Public Relations Director of EFPIA, notes that research indicates that reducing data protection will result in the loss of about 50 out of an expected 225 new therapies in Europe over the next 15 years. Additionally, this regulation could cause annual investment losses of approximately €2 billion. “The root causes of delays in access to innovative medicines in member states cannot be solved solely through EU legislation,” she emphasizes.

The Access Challenge for New Medicines in Greece

Greek patients face significant difficulties accessing new treatments, often waiting long periods for innovative medicines to be available locally. A 2023 EFPIA survey assessing the WAIT (Waiting to Access Innovative Therapies) index shows that Greek patients wait an average of 587 days to receive a new treatment. This is about two months longer than the European average.

More specifically, of the 167 medicines approved by the European Medicines Agency (EMA) between 2019 and 2022, an average of 72 (out of 167) were accessible in the countries included in the study (36 countries). In Greece, only 47% of these EMA-approved medicines during that period were available to patients.

The causes of access inequalities are multifaceted. Ms. Giannoutsou explains, “Factors include the speed of health technology assessments (HTA), differing reimbursement procedures, or additional decision-making layers at regional and local levels. Moreover, different countries, HTA bodies, and payers may require different data or accept different evidence from clinical practice (real-world evidence), while others do not.”

The 3 Critical Measures to Improve Access to New Medicines

“Rather than waiting years to solve access problems through legislation targeting the wrong issues with inappropriate policies, we believe that industry, the EU, and member states can make a difference if they sit together and work collaboratively,” says Ms. Giannoutsou. She highlights three key policies that EFPIA considers crucial for increasing access:

1. Improve the European regulatory framework through legislation:
   Europe is the slowest among major markets in approving new medicines, with an average of 426 days, compared to just 244 days in the US.
2. Maintain data protection (RDP):
   The EU should preserve the current data exclusivity period. For example, Japan implemented six years of RDP protection in 2003, which increased to eight years in 2007. Over the following decade, the number of clinical studies more than doubled.
3. Enhance access to clinical trials:
   The EU should streamline and expedite processes for member states, facilitating earlier and broader participation in clinical research.

Reasons Behind Medicine Shortages

Medicine shortages in Europe can result from various factors, including production constraints, unforeseen surges in demand due to health crises, improved diagnostic tools, changes in medical practices, or forecasting errors.

Furthermore, medicines have different production and distribution needs. For example, biologics, vaccines, and plasma-derived therapies often require specialized facilities due to their technical specifications. Based on these factors, the EU has established the Critical Medicines Alliance and is working on a common list of medicines that require careful management and predictability. However, in many cases, shortages also depend on national practices, such as the extent of parallel exports, which are not uniformly regulated.