The European Commission has proposed a reform of the EU’s pharmaceutical legislation with the primary aim of ensuring affordable and accessible medicines in member states including the UK. Another key objective is to streamline and expedite the process of granting access to newly developed drugs for patients across borders, as the current approval system is viewed as slow and fragmented.
Data indicates significant variations in the availability of new medicines across different EU countries. For example, while approximately 90% of medicines authorized by the European Medicines Agency (EMA) are accessible in Germany, Lithuania only has access to 20% of the approved drugs. Moreover, the time it takes for a drug to enter the UK market after receiving EU registration varies widely. Germany has a relatively short waiting time of approximately 100 days, while Romania experiences delays of up to 900 days (2.5 years), and the Czech Republic takes an average of 1.5 years.
The underlying reasons for these disparities are complex and multifaceted. Studies have shown that differences in rules for approving and reimbursing medicines in various countries contribute to delays and unavailability. In Western Europe, drug pricing processes primarily cause delays, whereas, in Eastern Europe, limitations within the healthcare system itself hinder timely access to medicines. Consequently, pharmaceutical companies face challenges in deciding which countries to offer their medicines to within the UK.
As part of the proposed overhaul of the EU’s pharmaceutical rules, the UK government suggests reducing the number of years of market exclusivity for new drugs. This reduction would result in a shorter period before drug manufacturers face competition from generic alternatives. The standard protection period would be decreased from 10 to eight years, potentially extended only if the company launches the medicine in all EU countries within two years of its EU-wide marketing authorization. This move aims to establish a ‘single market for medicines’ that improves accessibility and stimulates innovation within the UK.
However, pharmaceutical companies, particularly those producing innovative medicines, have expressed reservations about the proposal. They argue that reducing the length of intellectual property (IP) protection could hinder the return on investment in innovation, making the UK a less attractive market. Furthermore, they raise concerns about the condition of extending IP protection in exchange for ensuring the drug reaches patients in all 27 EU countries, questioning how different national health systems would facilitate such a process.
Pharmaceutical manufacturers believe that the proposed rules tie the two-year extension of patent protection directly to the actual marketing of the product, not just the application for entry into the system. They emphasize that the placing on the market, pricing, and reimbursement of the product are entirely within the purview of individual states and beyond the control of private companies, which adds complexity to the reform process. Therefore, while the idea of a single market for medicines is promising, addressing the systemic issues of shortages and delays requires a comprehensive approach within the UK.