Generic drugs in the EU’s internal market

A record of the advances since the European Commission’s sectoral inquiry.

We are writing to correct what we see as a misinterpretation by European Voice of the position of the European Generic Medicines Association (EGA) on the effects of the European Commission’s pharmaceutical sector inquiry on the sector. We believe your article (“Drug firms’ fears over Kroes probe fade”, 7-13 October) downplayed the results of the inquiry. 

You stated that we at the EGA “make only modest claims for the results” of the inquiry. This is an incomplete and unfair interpretation. We feel obliged to respond by outlining some key achievements in the sector in the year since the inquiry and by pointing out the significance of the Commission’s investigation in instigating other positive changes likely to become apparent in the years to come.

We would like to highlight the following constructive developments:

• The Commission has opened cases against a number of originator companies for alleged abuse of their dominant market position to prevent/delay patients’ access to generic medicines.
• The European Patent Office (EPO) is continuing to ‘raise the bar’ on quality patents, which is supported by the Commission’s inquiry. This includes accelerating opposition and appeal procedures and limiting the time period for filing voluntary divisional patents.
• The Price Transparency Directive is under revision, covering fundamental issues such as the acceleration of pricing and reimbursement decisions for generic medicines. These are expected to have a positive influence on competition on the internal market.
• The European Parliament’s committee on environment, public health and food safety, has passed an amendment against misinformation campaigns targeting the general public. This amendment prohibits comparisons between medicinal products on the basis of their quality, safety and efficacy, and prohibits a pharmaceutical company from disseminating information about medicines for which it does not hold marketing rights.
• As mentioned by the Commission in its response (“Vigilance will benefit EU’s pharmaceutical industry”, 14-20 October), several member states have followed up on recommendations from the inquiry to improve the access to their markets that generic medicines enjoy. For instance, Spain has accelerated the procedure for setting the price of genetics, and Italy has halted the linking of a patent’s status to the process of market approval. The Romanian National Medicines Agency has dismissed patent linkage claims by originators, while the Austrian Medicines and Medical Devices Agency has corrected misinformation about one medicine (clopidogrel).
• In a recent statement, the Italian competition regulator, Autorità Garante della Concorrenza e del Mercato (AGCM), in line with the inquiry’s recommendations, warned that patent litigation should not be allowed to cause unnecessary delays to the authorisation of generic medicines in Italy. Antonio Catricalà, AGCM’s chairman, stressed the need for regulation of the pharmaceutical production/distribution cha-in aimed at creating more competition. He said that this would result in improved conditions for research and development of new products, and would, by favouring the entry of new generic medicines onto the market, encourage more competitive pricing of off-patent medicines.

One year after the launch of the sector inquiry, the EGA sees much progress being made at a European as well as at a member-state level. We call for more regulatory and self-regulatory measures to be taken in the near future to allow patients to have immediate access to affordable generic medicines after patents expire.

From:

Greg Perry

Director-general

European Generic Medicines Association (EGA)

Brussels

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