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European Parliament’s adoption of ‘Options for improving access to medicines’ procedure

On March 2nd 2017, the European Parliament voted to adopt "EU options for improving access to medicines 2016/2057(INI)".

The procedure places generic, biosimilar and value-added medicines at the heart of the debate on access to medicines. Specifically, the report calls for Member States to encourage competition from generic and biosimilar medicines by removing barriers and adopting uptake measures, and introduces the first steps in the right direction by recognising the importance of value-added medicines innovation in the off-patent sector for patients.

The report provides the Commission and the Member States with a clear mandate to encourage more competition from generic and biosimilar medicines, underlining that generic medicines are a cornerstone of European healthcare, and that biosimilar medicines offer tremendous opportunity for access to biotherapies.  The report also recognises the innovation in the off-patent sector and the ways in which it can be beneficial for patients and deliver added value (hence value-added medicines). These types of medicines will help address major healthcare challenges such as delivering better adherence and quality of life, as well as improved safety and efficacy, and their benefits should be assessed.

MEPs are also reiterating the call on the European Commission to stimulate manufacturing and export of generic and biosimilar medicines to countries where no patent or Supplementary Protection Certificate (SPC) exists. A manufacturing waiver for generic and biosimilar medicines during the SPC period will increase access to high quality medicines in unprotected markets, without changing the equilibrium between the originator and the generic and biosimilar medicines industries in the EU.

These developments have moved some way to offset the recent turbulence seen in the generics market across the EU and US. Manufacturers are facing stiffer regulations and price caps, and marketing companies are seeing less opportunities to manoeuvre in highly saturated markets with low margins and volumes.

At ELC Group we pride ourselves on being at the forefront of regulatory decision making and help our clients to build their pipeline strategies on such intelligence. This report sends a clear message that the EU is still keeping generics at the forefront of its fight to increase access to medicines at fair prices.


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