For patients with serious illnesses, timely access to effective medicines is critical. The European Medicines Agency (EMA) was created in part to help speed up drug approvals and ensure these products are safe and effective.As stated in a paper Greenwald and Stargardt (2024):
European Medicines Agency [European Medicines Agency] Established in 1995 primarily to harmonize the marketing authorization of medicines in the European Union and the European Economic Area…as there are huge differences in delays and availability of medicines between European countries
The EMA has 3 key Community procedures that grant market access to some or all EU member states simultaneously.
- Centralized Program (CP). If the EMA evaluates a medicine and grants it marketing authorization, the decision is binding on all EU member states. Introduced in 1995, CP was initially used only for “biotechnological processes such as monoclonal antibodies, controlled gene expression or recombinant DNA technology”. The list of treatments evaluated under the CP has been expanded to include orphan drugs and substances against cancer, diabetes and HIV/AIDS (2005), viral diseases and autoimmune diseases/dysfunctions (2008), and advanced therapeutics ( e.g., cell and gene therapy) also in 2008.
- Mutual Recognition Process (MRP). In this case, the assessment is carried out by the reference Member State, which the applicant is free to choose, and whose decision is subsequently adopted by all other Member States in which the applicant seeks market access. This procedure was adopted in 2001 and includes new treatments other than CP, such as other drugs and generics.
- Decentralized Program (DCP). The act, passed in 2005, allows drug manufacturers to seek approval on a country-by-country basis. This only applies to new substances that are not subject to CP or MRP.
To examine the impact of these procedures, Greenwald and Stargardt (2024) A difference-in-differences analysis is conducted comparing countries that comply with these Community procedures with those that do not. Specifically, with the enlargement of the EU, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia and Slovenia joined the EU on this date in 2004 (Cyprus and Malta also joined the EU on this date, but the authors do not have data for these countries ). Bulgaria and Romania joined the EU in 2007, followed by Croatia in 2013. In comparison, Belarus, Bosnia and Herzegovina, Kazakhstan, Russia, Serbia, Switzerland and Turkey have never joined the EU. Using IQVIA sales data from 33 European countries, the authors examined (i) launch delays and (ii) availability of new active substances. The author found that
… launch delays decreased by an average of 10.9 months across countries (p = 0.004) after joining the EU. Effects are higher for drugs belonging to indications where participation in CP may be voluntary but not obligatory. These drugs are often less economically attractive to manufacturers than drugs within the mandate. The supply of new medicines that have been launched is not affected. We find indications that the magnitude of the country-specific impact of centralized marketing authorization on launch delays may be affected by country-level manufacturer strategic decisions (such as parallel trade or reference pricing).
For more details, you can read the full article here.
