Pharma's Reality Check: A Single Medicine Market Isn't the Magic Pill

Europe: The European Commission has proposed a reform to the EU's pharmaceutical legislation in April 2023 to address concerns about the accessibility and affordability of medicine in member states. The primary focus of the reform is to ensure faster and equal access to newly developed drugs for patients across borders, as the current process of approving new medicines is seen as slow and fragmented. In Germany, approximately 90% of approved medicines are available to citizens, while in Lithuania, only 20% are accessible. Furthermore, there is a significant delay in the time it takes for a drug to appear on the national market after receiving EU registration, which is a major issue that needs to be addressed.

Germany leads the pack with an average waiting time of approximately 100 days, making it the most efficient country in terms of modern medicine approvals. On the other hand, Romania has the longest wait time, with a process that can take up to 900 days or 2.5 years. The Czech Republic has an average waiting time of 1.5 years.

The process for approving and reimbursing modern medicines varies from country to country. In Western Europe, delays and unavailability of marketing authorizations are typically due to drug pricing processes. However, in Eastern Europe, limitations in the healthcare system itself often cause delays or a lack of supply.

These differences have a significant impact on pharmaceutical companies' decisions regarding which countries they should offer their medicines in.

The European Commission has proposed changes to the EU's pharmaceutical regulations, which include a longer market exclusivity period for newly developed drugs. The standard protection period would be reduced from 10 to eight years but could be extended if the medicine is launched across all EU countries within two years of receiving its EU-wide marketing authorization. This proposal also aims to establish a "single market for medicines" to improve accessibility and promote innovation.

Pharmaceutical companies have expressed worry over the proposal to create a single market for medicines, claiming that it won't completely solve the issue of shortages and delays. Although the idea can bring numerous benefits, including improved accessibility, the manufacturers of innovative drugs believe that a longer period of intellectual property (IP) protection is necessary to ensure a return on investment in innovation and make Europe an attractive market. The industry argues against the condition of extending the duration of IP protection "in return" for making the drug available to patients in all 27 countries, citing concerns about how different national health systems would handle such a process.

According to the new rules, drug manufacturers must market their product to qualify for a two-year extension of patent protection. This goes beyond just applying for entry into the system, which the industry has previously committed to. However, industry representatives argue that individual states have complete control over the sale, pricing, and reimbursement of the product, which is outside the jurisdiction of private companies.