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5EU: Pricing, Reimbursment and Regulatory Update

Datamonitor, Oct 2011, Pages: 35


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Governments across the five major EU markets (France, Germany, Italy, Spain, and the UK) have been busy implementing regulatory, pricing, and reimbursement reforms in 2011. Price cuts have impacted brands, while pro-generic measures and new market access and reimbursement requirements could negatively impact pharma. However, there are moves to improve patient access to certain novel drugs.

Features and benefits

- Insight into regulatory and pricing and reimbursement issues in France, Germany, Italy, Spain, and the UK.
- Overview of regulatory reform issues in France, Germany, Italy, Spain and the UK.

Highlights

- Driven by their high budget deficits post-recession, both Italy and Spain pushed through their austerity packages in 2011, which has led to substantial drug price cuts in both countries. Furthermore, pro-generic measures are being introduced to help reduce overall drug expenditures.
- Pharmaceutical companies will also need to be mindful of new market access and reimbursement requirements which could make it harder to secure reimbursement, with new drugs needing to prove their cost effectiveness against active comparators in both France and Germany.
- Several countries are working on improving access for patients to certain innovative and expensive drugs. As well as benefiting patients by giving them access to drugs they would not otherwise have been able to obtain, these measures will have a positive impact on pharma by securing higher revenue streams for companies that manufacture them.

Your key questions answered

- Evaluate the key pricing, reimbursement, and regulatory issues in the 5EU markets and their impact on branded pharmaceutical market access and uptake
- Gain insight into the strategies employed by pharmaceutical companies in response to changes in the regulatory environment.



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