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Data protection
We regret:
• the Commission rejected an amendment recommending that individual
Member States need not be bound by the 10-year data protection period
(some currently protect data for only 6 years) (amendment 46, article
138).
Developing countries
Pathetic:
• the Commission rejected all amendments calling for active
solidarity with poor countries, including exportation restricted
to drugs with proven efficacy, safety and quality; research incentives
for diseases affecting the poorest countries; co-operation on pharmaceuticals,
etc. (amendments 7, 8, 26 and 94). The Commission considered that
such proposals were outside the scope of the draft Regulation.
Pricing
Cause for concern:
the Commission accepted to apply the rule whereby drug pricing negotiations
between companies and national authorities should not exceed 180
days (amendments 15 and 47, considering 30bis, article 13bis).
©La revue Prescrire 15 January 2003
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