Examination of MAH objections


Dear colleagues,

Following a three-day session, the prices committee recessed so that the services of EOF may deal with the further processing of data, based on the needs that emerged from the issues discussed in the committee. All companies who were present in the Ministry were allowed to express their views.

The session is normally expected to resume at the end of the following week.

During the session, substantial problems were identified in the following categories:

  1. Products that sustained substantial decreases (flat) after the loss of the data protection in which the marketing of the first generic occurred long after the loss of the patent protection, so their prices are at risk of being further reduced.
  2. The need for the date of marketing of the first generic to be expressly clarified, given that EOF has not taken into account the right dates in many cases. This fact affects the prices of important off patent medicinal products and many generics.
  3. A substantial number of products is below the average of the 3 lower prices and a substantial percentage thereof is below the lowest price in Europe, either due to the application of this Ministerial Decision, or due to long-term distortions of the past.

In addition, there are isolated problems with the accuracy of the 3 lower countries.

At all times, the association supported the rightfulness of the requests of its members. We also point out the distortion created by the existence of products with a price below the average of the 3 lower countries and in particular, below the lowest price in Europe. The outcome of the requests remains unknown, given that the services of EOF continue to work on these pending issues.

In addition, the political will of the Ministry on the final form of the prices bulletin is expected to play an important role, since the legal impediment of products being specifically below the lowers price in Europe, is not taken as granted.

We believe that at this stage, the regular contact of the companies with the services for no specific reason (e.g. production of data) will not contribute to the favourable progress of the procedure.

Finally, we would like to point out that the procedure is conducted in a positive climate with increased transparency.

Olympios Papadimitriou                               Zefi Vostitsanou

Vice – President                                                         Director of Scientific & Governmental Affairs

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