GENERIC MEDICINES - A NEW TRIAL FOR THE DEPUTIES
The Bulgarian Parliament plans to vote by mid-July a bill for amendments to the Act on Medicines that would facilitate local medicine producers. Medical treatment of patients will become cheaper if the MPs approve the draft.One of the most important provisions in the bill (article 3, item 18) is for the intoduction of the Roche-Bollar rule, which is a part of all similar laws of the EU members. The change will give a free hand to companies, which have not invested money in the initial development of the product, to manufacture a similar medicine without considering that a violation. Such products are not fake. They are called generic and have the same ingredients as the original medicines. Their proven effect is the same as of the original products but are up to 3-fold cheaper than them because less money has been invested. About USD600MN is necessary for launching an absoluteley new mediciene, while the manufacturer pays only for the substance for the prodcution of its generic analogue.The original medicine Loratidin against allergies, caused by blossoming willows, costs some BGN8-12, depending on the surplus which each pharmacist charge. The Bulgarian analogue of the medicine can be have for BGN3.50 only, Ognyan Palaveev, Director of Unipharma and Chairman of the Association of Bulgarian Pharmacists, explained.A quick inquiry of the BANKER weekly has established that the MPs (who should vote on second reading the bill by mid-July) do not exactly understand the meaning of the Roche-Bollar rule and that its application would promote the local pharmaceutical industry.The MP from the parliamentary group of the Union of Democratic Forces (UDF) Dr. Dimitar Ignatov admitted to a reporter of the BANKER weekly that he did not know what its all about. I have not asked about it, but I'm sure there are some shady interests of people from the National Movement Simeon II (NMSII) behind that proposal. Therefore, my colleagues from the UDF and me will controvert it, Dr. Ignatov promised.It turned out that the doctors from the Coalition for Bulgaria were neither more prepared for the vote in two weeks. According to the deputy from the NMSII Dr. Antoniya Purvanova, the Bulgarian pharmaceutical industry needs urgently a permission to prepare for the production of generic medicines until the original ones are still protected by patents. This will result in transparency in the operation of companies and will intercept the possibility for the import of really fake medicines from Macedonia and Singapore, while the producers of the orinials will know what generic developments will be worked out on the basis of their products, Dr. Purvanova specified.If the Roche-Bollar rule is not approved into the amendments to the Act on Medicines, the owners of Balkanpharma - Iceland's Irish Pharmaco - might redirect their investment to reserch activities in other countries of the continent where the rule has alerady been legalized, Vladimir Afionliev from Balkanpharma said in front of the BANKER weekly. When closing the privatisation contract three years ago the Icelanders undertook a commitment to invest USD45MN in Balkanpharma within five years. They already invested USD11MN in 2001 and project to invest another USD20MN by end-2002.