1. EMA and FDA do not have the same requirements when evaluating a registration file. Anticipate the design of your phase 2 and 3 clinical trials to account of these differences.
2. Every European country has a specific healthcare system, with variations of reimbursement procedures and requirements (timing, dossier, price). Reimbursement decisions will be made by a combination of regional and national committees: national has precedence in some countries like France but regions can be the main decision-makers in other countries like Germany or Italy, despite using guidelines issued by national committees.
3. Medical practices are rather homogeneous across Europe. There is generally a European Expert Society for each therapeutic area, gathering members of national societies. Therefore, practitioners usually follow the same guidelines, published by these European Expert Societies.
4. There are numerous patient advocacy groups and associations, organized at the regional, national, and pan-national level. In some disease areas, such as AIDS, these groups can be quite influential. This is true both in the US and the EU, and it is normal for groups focused on the same areas to exist on both continents.
5. The registration procedure (CE mark) for medical devices and diagnostics is more simple and straightforward than in the US, but reimbursement is country-dependent and may be quite slow (up to several years). However, regulations are changing, and the registration process will become more demanding for Class 2b and 3 devices. Read more here.
6. For diagnostics, there is no such thing in Europe as the LDT status allowing quick commercialization on a limited scope through CLIA labs.
7. Depending on disease areas, your commercial model will be different across countries. You will generally have to be more payor-centered in Northern Europe and more physician-centered in Southern Europe, with several countries such as Germany standing in-between.
8. All European payors will demand comparative trial data with the standard of care. This will have tremendous implications on your trial design and must be anticipated.
9. HEOR studies may be quite useful in some countries but not relevant in others due to different funding processes and stakeholders, or different evaluation methodologies at national level. For example, France’s HAS does not fully recognize QUALYs as a valid outcome measure.
10. Private health insurance companies have little influence over the reimbursement process of most drugs and devices. They usually follow the decisions of the National Healthcare System.
11. For most drugs, a certain launch sequence has to be followed in order to maximize reimbursement prices. You must start with countries with fast processes and high historical prices, and end with low-price and/or slow countries such as Italy, Spain or Eastern European countries.