Light and shade in proposed revision of EU drug-regulatory legislation
2003; Elsevier BV; Volume: 361; Issue: 9358 Linguagem: Inglês
10.1016/s0140-6736(03)12615-3
ISSN1474-547X
AutoresSilvio Garattini, Vittorio Bertelè, Luca Li Bassi,
Tópico(s)Intellectual Property and Patents
ResumoIn a first reading on Oct 23, 2002, the European Parliament approved the draft Directive and Regulation on medicines 1 http://www3.europarl.eu.int/omk/omnsapir.so/calendar?APP=PDF&TYPE=PV2&FILE=p0021023EN.pdf&LANGUE=EN Google Scholar , 2 http://www3.europarl.eu.int/omk/omnsapir.so/calendar?APP=PDF&TYPE=PV2&FILE=p0021023EN.pdf&LANGUE=EN Google Scholar ) significantly amending the Commission's original proposal, 3 Commission of the European Communities http://pharmacos.eudra.org/F2/review/doc/finaltext/011126-COM_2001_404-EN.pdf Google Scholar , 4 Commission of the European Communities http://pharmacos.eudra.org/F2/review/doc/finaltext/011126-COM_2001_404-EN.pdf Google Scholar which had also been discussed a few weeks earlier by the Parliament Committee on the Environment, Public Health and Consumer Policy (ENVI). 5 Committee on the Environment, Public Health and Consumer Policy. http://www2.europarl.eu.int/omk/sipade2?PUBREF=-//EP//NONSGML+REPORT+A5-2002-0330+0+DOC+PDF+V0//EN&L=EN&LEVEL=2&NAV=S&LSTDOC=Y Google Scholar , 6 Committee on the Environment, Public Health and Consumer Policy. http://www2.europarl.eu.int/omk/sipade2?PUBREF=-//EP//NONSGML+REPORT+A5-2002-0340+0+DOC+PDF+V0//EN&L=EN&LEVEL=2&NAV=S&LSTDOC=Y Google Scholar The present revision has improved the original version, as indicated by positive views (panel). 7 Rogers A European Parliament approves pharma law overhaul. Lancet. 2002; 360: 1397-1398 Summary Full Text Full Text PDF PubMed Scopus (1) Google Scholar , 8 Europe et médicament: les parlementaires européens ont choisi la santé publiqueLa Revue Prescrire Nov 1, 2002. http://www.prescrire.org/aLaUne/dossierEuropeParlement.php Google Scholar Some statements of principle echo those of the Regulation that established the European Medicines Evaluation Agency (EMEA) 9 Council regulation (EEC)no 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Off J Eur Comm. 1993; 1 (no L 214, Aug 24): 1 Google Scholar —and clearly indicate the legislators' intent. However, there is room for improvement. •Centralised procedure mandatory for all new active substances, not only for biotech products and orphan drugs. •CPMP arbitration required when there is disagreement in mutual recognition procedures: withdrawal of application in reluctant Member States will no longer lead to different outcomes for same application across EU. •Improved pharmacovigilance system with integrated EU network. •Possibility for generic producers to prepare for product launch before patent on innovator drug expires, so that generics can be marketed day after protection expires. •Generic manufacturing allowed if medicine is intended for export to third country that has issued compulsory licence for that product, or where patent is not in force and if there is request to that effect from competent public-health authorities. In line with WHO position, 12 Correa CM Implications of the Doha Declaration on the TRIPS Agreement and Public Health. WHO/EDM/PAR/2002.3. 2002. http://www.who.int/medicines/library/par/who-edm-par-2002-3/doha-implications.doc Google Scholar this is possible solution to Paragraph 6 anomaly of Doha Declaration on TRIPS and public health 13 World Trade OrganisationMinisterial Conference (fourth session, Doha, Nov 9–14, 2001). Doha Ministerial Declaration on the TRIPS Agreement and Public Health. 2001: WT/MIN(01)/DEC/W/2. http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf Google Scholar which allowed developing countries to import generic medicines to meet health needs but, paradoxically, restricted generic producers when exporting. •Full rejection of pilot project for direct-to-consumer advertising. Requirement that new drugs be appropriately tested in women and children. •Requirement to reconsider risk-benefit balance of new drugs once after first 5 years of marketing, which is compromise between current requirement of 5-yearly reviews and Commission's proposal for unlimited validity of marketing authorisations. •80 days allowed for analysis of scientific data supporting marketing-authorisation application, compared with present 70. •Several transparency measures, such as publication of CPMP assessment reports, of reasons for its opinions and for any divergent positions, of reasons for withdrawal of applications by applicants, and of specific obligations agreed with companies. •Centralised procedure mandatory for all new active substances, not only for biotech products and orphan drugs. •CPMP arbitration required when there is disagreement in mutual recognition procedures: withdrawal of application in reluctant Member States will no longer lead to different outcomes for same application across EU. •Improved pharmacovigilance system with integrated EU network. •Possibility for generic producers to prepare for product launch before patent on innovator drug expires, so that generics can be marketed day after protection expires. •Generic manufacturing allowed if medicine is intended for export to third country that has issued compulsory licence for that product, or where patent is not in force and if there is request to that effect from competent public-health authorities. In line with WHO position, 12 Correa CM Implications of the Doha Declaration on the TRIPS Agreement and Public Health. WHO/EDM/PAR/2002.3. 2002. http://www.who.int/medicines/library/par/who-edm-par-2002-3/doha-implications.doc Google Scholar this is possible solution to Paragraph 6 anomaly of Doha Declaration on TRIPS and public health 13 World Trade OrganisationMinisterial Conference (fourth session, Doha, Nov 9–14, 2001). Doha Ministerial Declaration on the TRIPS Agreement and Public Health. 2001: WT/MIN(01)/DEC/W/2. http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf Google Scholar which allowed developing countries to import generic medicines to meet health needs but, paradoxically, restricted generic producers when exporting. •Full rejection of pilot project for direct-to-consumer advertising. Requirement that new drugs be appropriately tested in women and children. •Requirement to reconsider risk-benefit balance of new drugs once after first 5 years of marketing, which is compromise between current requirement of 5-yearly reviews and Commission's proposal for unlimited validity of marketing authorisations. •80 days allowed for analysis of scientific data supporting marketing-authorisation application, compared with present 70. •Several transparency measures, such as publication of CPMP assessment reports, of reasons for its opinions and for any divergent positions, of reasons for withdrawal of applications by applicants, and of specific obligations agreed with companies. 1-year retention and social function after buprenorphine-assisted relapse prevention treatment for heroin dependence in Sweden: a randomised, placebo-controlled trialThe combination of buprenorphine and intensive psychosocial treatment is safe and highly efficacious, and should be added to the treatment options available for individuals who are dependent on heroin. 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