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Guest article by Ancel·la Santos, Senior Health Policy Officer, The European Consumer Organisation (BEUC) 

To ensure recovery when facing health issues and a better quality of life among European citizens, it is essential that people get timely access to medicines and that they are affordable.  However, in the EU there are significant disparities in accessing medicines, which combined with other factors, contribute to significant health inequalities across the EU. 

Some new medicines that have been approved by the European Medicines Agency (EMA) do not reach patients in all countries, one of the factors being the absence of a requirement for marketing authorisation holders to enter markets across the EU. 

Soaring medicine prices are another challenge, particularly in some therapeutic areas. High medicine prices put heavy strains on public health budgets, reducing funds available for other necessary health services and undermining the possibility for the state to reimburse certain medicines. In 2016, a study looking at the accessibility of anti-cancer medicines in Europe showed that the cost and affordability of new treatments was the major factor behind inequity of access across countries. 

The revision of the EU general pharmaceutical legislation is an opportunity to solve these problems. To get there, the legislation must: 

1. Promote EU-wide availability of EMA approved medicines 

The EU should adopt measures that promote the availability of medicines approved by the EMA across Member States. To start with, the revised legislation should require originator companies to inform regulators about their market launch plans. In addition, these companies should file for pricing and reimbursement in all EU countries within a short timeframe, with any exceptions approved by national competent authorities on a case-by-case basis.  

The legislation could also provide originator companies that do not want to place a product on a specific market with the alternative to grant generic companies the right to market and sell the medicine under fair and reasonable licensing conditions. To ensure transparency, the legislation should require the Commission to set up a public database that reports on the availability (understood as a product that is placed on the market) of EMA approved medicines across the EU. 

Some of these measures could also be considered, and adapted as necessary, for generic products with a central marketing authorisation.

2. Introduce different data and market protection periods with safeguards 

The EU must ensure that exclusivities granted to companies that incentivise drug development are proportionate and prevent excessive prices and profits. To that end, the revised legislation should lay down different periods of data and market protection, with the longest period given for medicines for serious diseases/health threats for which there is less commercial interest, for example, novel antibiotics. If the legislation introduces protection periods that go beyond the status quo, this should only be possible if there is an evidence-based justification on a lack of return on investment. 

In general, the revisited legislation should include possibilities to reduce protection periods to prevent abuses, which in turn requires companies to share data on research and development costs. In addition, generics and biosimilar products should be able to more easily enter the market the very first day that IP protection on the originator product expires.  

For more information and recommendations to improve access to medicines in Europe: ’Addressing barriers for consumers to access medicines in the EU. BEUC position paper on the revision of the EU general pharmaceutical legislation.’’