Presidential act eases access to generic medicines in the US

As European parliamentarians are preparing to vote in first reading on the Pharma Review package, the US President has eased access to generic drugs.

On 21 October, two weeks before the US congressional elections and two days before the European Parliament's vote in first reading on the pharmaceutical package, President George W. Bush took action to speed up the entry of lower-cost generic drugs' to the US market.

On average, a patent for new drugs is protected for 11 years in the US after which generic versions may appear. However, in recent times, some companies filed for a new patent based on a minor feature unrelated to the drug's effectiveness or started lawsuits to resolve allegations that a generic drug maker is infringing a drug patent. As a result, on occasion, they obtained repeated 30-month delays (or "automatic stays") in court, therefore, significantly delaying access to generic drugs. The specific measures proposed by the President includes a one 30-month automatic stay per generic drug application while a challenge is contested.

Regulatory data protection is a major issue in the EU pharmaceutical review (see also

EURACTIV, 18 October 2002). Under the Commission's original proposal on Regulatory Data Protection, 10 years of protection would be provided for the data collected to obtain an initial marketing authorisation, plus an additional year for data generated to support certain new indications developed, when a product is already on the market. The Parliament's Environment Committee, however, adopted an amendment to enable generic medicinal products to apply for authorisation 8 years after the reference medicinal product is approved. The production and marketing of the generic medicinal product authorised on this basis would have to wait an additional two years.

The European Parliament debated the package on 22 October. The plenary vote in first reading is to take place on 23 October.


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