COMMISSION PROPOSALS TO REVISE TRANSPARENCY DIRECTIVE ADDRESS
KEY RECOMMENDATIONS OF THE PHARMACEUTICAL SECTOR INQUIRY
"The revision of the Transparency Directive must be viewed as an opportunity to implement certain key recommendations of the Pharmaceutical Sector Inquiry* which identified reasons why generic medicines are blocked or delayed from entering the market. We therefore welcome the European Commission's decision to take on board measures that will help guarantee that generic medicines will continue to be made available to as many patients as quickly as possible at affordable prices" said Greg Perry, EGA Director.
Today, generic medicines play an essential role in treating disease by increasing the accessibility and affordability of modern day pharmaceuticals in European global healthcare systems. The sustainability of the generic medicines sector is vital to ensure that these benefits accrue into the future and essential medicines continue to be made available to as many patients as possible without deference to cost. As declared by the European Commission Vice President Antonio Tajani, responsible for Industry and Entrepreneurship: "Our proposal will lead to substantial savings for public health budgets, for example by allowing earlier market entry of generic products".
In line with the Pharmaceutical Sector Inquiry recommendations, the revision contains three points of vital importance to ensure quicker patient access to generic medicines:
• Introduces a 30-day price & reimbursement approval time-limit for generic medicines – this will help to maximise potential savings to patients and the healthcare sector, whilst increasing affordability, patient access and health budget control.
• Puts an end to patent linkage, which links the approval of the price and reimbursement of generic medicines to the patent status of the originator reference product - this will foster a competitive market by speeding up the entry of generic medicines onto the market, thereby realising savings and creating access to affordable treatments. This is in line with jurisprudence in various Member States that ruled against patent linkage in the price and reimbursement process.
• Eradicates double bioequivalence assessment by pricing and reimbursement authorities – this will ease market delay, and is logical where the reference product has already been in the market place for several years.
"The Commission has recognised with these proposed amendments to the legislation that generic medicines and biosimilars are major contributors to the sustainability of European healthcare systems, providing over 150000 jobs and bringing savings of more than Euros 35 bn per year, while increasing patient access to affordable treatments" Greg Perry concluded.
*http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/communication_en.pdf