European Parliament Recognises the Major role of Generic, Biosimilar and Value Added Medicines in Improving Access

• Medicines for Europe welcomes the European Parliament’s adoption of its report on ‘Options for improving access to medicines’ that 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.
• Medicines for Europe calls on the Commission and Member States to rapidly translate these proposals into concrete policies that support Member State healthcare system sustainability and efficiency.

Today, the European Parliament voted on the report on ‘Options for improving access to medicines’ that places generic, biosimilar and value added medicines at the heart of the debate on access to medicines. Together with the June 2016 Council Conclusions, this 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 biosimilar medicines offer tremendous opportunity for access to biotherapies.

The report also recognises the innovation in the off-patent sector as 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 better safety and efficacy and their benefits should be assessed.

“We urge the Commission and Member States to take action to ensure that these proposals are translated into real support measures for generic, biosimilar and value added medicines, allowing all patients across Europe to get access to the treatment they need” commented Adrian van den Hoven, Medicines for Europe Director General.

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.