Home Generics Biosimilars Docs & Positions Facts & Figures Press Room Conferences

EGA Press Release

Friday, 25 September 2009

QUICK IMPLEMENTATION OF SECTOR INQUIRY RECOMMENDATIONS
IS THE ROADMAP FOR BUILDING SUSTAINABLE HEALTHCARE SYSTEMS
IN SOUTH EAST EUROPE

"National agencies from the South East European region should intensify cooperation and harmonisation and look at strengthening their regulatory framework. Quick alignment with the recommendations of the European Commission’s pharmaceutical sector inquiry report is the roadmap for building a sustainable pharmaceutical sector throughout Europe” says EGA director general, Greg Perry opening the 5th EGA South East Europe Pharmaceutical Symposium in Ohird, Macedonia.

This 5th edition of the symposium is organised on 24-25 September in cooperation with the Ministry of Health of Macedonia and the leading Macedonian pharmaceutical company Alkaloid. Over one hundred and fifty delegates are gathering for two days to foster cooperation and improve regulatory procedures in the region. Delegates at the Symposium include top-level representatives of the medicines and patent authorities from Albania, Bosnia-Herzegovina, Bulgaria, Croatia, Hungary, Kosovo, Macedonia, Montenegro, Romania, Serbia and Slovenia.

Welcoming the participants during the plenary session, Mr Perry stated “Generic medicines are the key to sustainable healthcare systems. They represent today 50% of all medicines dispensed to patients in Europe, but only account for 18% of pharmaceutical expenditure. Generic medicines are a fundamental necessity in many of the South East European countries who are seeking headroom in their budget”. A particular objective in the region is therefore to provide generic medicines to patients by the harmonisation of the regulatory framework. Mr Perry also warned against adopting any additional data exclusivity provisions as these could negatively impact access to generic medicines. Finally, Mr. Perry reiterated that patent linkage is totally contrary to EU regulatory procedures and would ultimately deprive patients of the medical care they deserve.

Mr Perry shared with the audience the recommendations of the pharmaceutical sector inquiry report released on 8 July 2009, which was initiated by the European Commission to identify inefficiencies that create obstacles to rapid access for consumers to affordable generic medicines. The European Generic Medicines Association welcomes the conclusions and recommendations of the report as they should enhance generic competition in the European healthcare sector and generate significant cost savings to healthcare systems, patients and tax payers.

In line with the European Commission’s recommendations Mr Perry urged authorities in relation to generic medicines to:

  • Accelerate their approval procedures
  • Grant automatic price and reimbursement approvals
  • Ensure that third party interventions do not occur to delay their approval of marketing authorisation, price and reimbursement
  • Prevent misinformation campaigns by competitors

For further information contact Beata Stepniewska at EGA
Tel: +32 (0)2 736 84 11