EMA and delays in drug launch – Healthcare Economist

For sufferers with severe sicknesses, timeline entry to efficacious drugs is paramount. The European Medicines Company (EMA) was created partially to assist expedite drug approvals and insure these merchandise are save and efficient. As acknowledged in a paper by Grünwald and Stargardt (2024):

The EMA [European Medicines Agency] was based in 1995 primarily to harmonize the advertising and marketing authorization of prescription drugs within the EU and EEA…as there had been substantial variations amongst European nations by way of launch delay and the provision of prescription drugs

The EMA had 3 key group procedures that grant entry to the markets of some or all EU member nations concurrently.

  • Centralized process (CP). If the EMA evaluates a pharmaceutical and grants IT advertising and marketing authorization, this dedication is binding all all European Union member states. CP was launched in 1995 and was initially used just for “biotechnological processes, resembling monoclonal antibodies, managed gene expression or recombinant DNA Technology”. The checklist of treamtents evaluated underneath CP has expanded to includeorphan medication and substances in opposition to most cancers, diabetes, and HIV/AIDS (in 2005), viral illnesses and auto-immune illnesses/dysfunctions (in 2008), and superior remedy medicinal merchandise (e.g., cell and gene-therapy) additionally in 2008.
  • Mutual recognition process (MRP). On this case, the evaluation is carried out by a reference member state, which the applicant can select freely and whose resolution is subsequently adopted by all different member states by which the applicant seeks market entry. This process was adopted in 2001, and contains new therapies which are exterior of the CP resembling different prescription drugs and generics.
  • Decentralized process (DCP). Adopted in 2005, this might permit pharmaceutical producers to hunt nation by nation approval. That is solely eligible for brand new substances not ruled by CP or MRP.

To look at the influence of those procedures, Grünwald and Stargardt (2024) conduct a differences-in-differences evaluation evaluating nations topic to those group procedures in opposition to those that weren’t. Particularly, with EU enlargement, in 2004 the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia and Slovenia (Cyprus and Malta additionally joined the EU on this date however the authors didn’t have knowledge from these nations). In 2007, Bulgaria and Romania joined the EU after which Croatia joined in 2013. In distinction, Belarus, Bosnia and Herzegovina, Kazakhstan, Russia, Serbia, Switzerland , and Turkey by no means joined the EU. Utilizing IQVIA gross sales knowledge from 33 European nations, the authors examined (i) the launch delay and (ii) the provision of latest lively substances. The authors discover that,

…nations skilled a imply lower in launch delay of 10.9 months (p = 0.004) after becoming a member of the EU. Results have been larger amongst prescription drugs that belong to indications that may voluntarily take part within the CP however will not be obliged to. These are sometimes financially much less enticing to producers than prescription drugs inside the obligatory scope. Availability of latest prescription drugs launched remained unaffected. We discovered indicators that the magnitude of the country-specific impact of centralized advertising and marketing authorization on launch delay could also be influenced by strategic selections of producers on the nationwide stage (e.g., parallel commerce or reference pricing).


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