Judge Brybe
Junior Member
- Joined
- Feb 5, 2010
- Member Type
- English Teacher
- Native Language
- Russian
- Home Country
- Russian Federation
- Current Location
- Russian Federation
Last week RSPP, the State Duma and the Ministry of Public Health were turned into platforms for public debate over the draft law on circulation of medicines, already dubbed ‘the law of the decade’. Comments ranged from highly negative to ones praising the document as a ‘high-quality’ one. The Duma vowed to conduct parliamentary proceedings prior to second reading of the amended draft law.
[FONT="]The draft law on circulation of medicines, emanating from the Public Health Ministry, is supposed to enter into force on September 1, 2010 replacing the obsolescent 1998 federal law on medicines. Already passed on first reading by the Duma on January 29, the document came under severe criticism from manufacturers of pharmaceuticals. Everybody agrees that the current law was ripe for revision, and yet the leitmotif of the RSPP discussion was that the draft law was ‘impossible to enact in its present stage’. The Association of the Russian Pharmaceutical Manufacturers (ARPM) pointed to its lack of harmonization with international regulations and called for a more elaborate conceptual framework of the document. For example, the procedure for determination of price ceiling for essential drug list pharmaceuticals uses the notion of ‘innovative drug’ which is somehow absent from the draft law. According to ARPM head Viktor Dmitriyev, the draft law gives no clear vision of the officials’ and government agencies’ responsibility for decisions taken in the market. ‘Signing the bill into a law in its current state will turn the clock back 5-7 years on the whole industry’, said Executive director of the Association of International Pharmaceutical Manufacturers Vladimir Shipkov, adding that the provision demanding mandatory design measures for clinical trial of drugs already proven safe and effective abroad would simply result in soaring drug prices besides adding 3-7 years to the new drug registration process in Russia. Co-chairman of the Russian Patient League Alexander Saversky voiced concern that the draft law makes no mention of patients. The draft law violates the doctor’s and patient’s right to choose therapy, Saversky said. The Federal Antimonopoly Service called the draft law ‘outright weak’. According to Head of FAS Department for Protection of Competition in the Social Sphere and Trade Timofey Nizhegorodtsev, separating registration from trial procedures may result in losing control over drug quality altogether.
Collocations, grammar, style, everything. Thanks a million. Brybe.
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[FONT="]The draft law on circulation of medicines, emanating from the Public Health Ministry, is supposed to enter into force on September 1, 2010 replacing the obsolescent 1998 federal law on medicines. Already passed on first reading by the Duma on January 29, the document came under severe criticism from manufacturers of pharmaceuticals. Everybody agrees that the current law was ripe for revision, and yet the leitmotif of the RSPP discussion was that the draft law was ‘impossible to enact in its present stage’. The Association of the Russian Pharmaceutical Manufacturers (ARPM) pointed to its lack of harmonization with international regulations and called for a more elaborate conceptual framework of the document. For example, the procedure for determination of price ceiling for essential drug list pharmaceuticals uses the notion of ‘innovative drug’ which is somehow absent from the draft law. According to ARPM head Viktor Dmitriyev, the draft law gives no clear vision of the officials’ and government agencies’ responsibility for decisions taken in the market. ‘Signing the bill into a law in its current state will turn the clock back 5-7 years on the whole industry’, said Executive director of the Association of International Pharmaceutical Manufacturers Vladimir Shipkov, adding that the provision demanding mandatory design measures for clinical trial of drugs already proven safe and effective abroad would simply result in soaring drug prices besides adding 3-7 years to the new drug registration process in Russia. Co-chairman of the Russian Patient League Alexander Saversky voiced concern that the draft law makes no mention of patients. The draft law violates the doctor’s and patient’s right to choose therapy, Saversky said. The Federal Antimonopoly Service called the draft law ‘outright weak’. According to Head of FAS Department for Protection of Competition in the Social Sphere and Trade Timofey Nizhegorodtsev, separating registration from trial procedures may result in losing control over drug quality altogether.
Collocations, grammar, style, everything. Thanks a million. Brybe.
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