Inpharma 1376 - 1 Mar 2003

Proposed revision of EU pharmalaw

The proposed revision of the EU medicines codecontains several positive aspects, although "there isroom for improvement", states the Lancet, in referenceto the fact that, in October last year, the EU Parliamentagreed to a proposed legislative change to the EuropeanCommunity (EC) code relating to medicinal products forhuman use.* The following points could be reconsideredby Parliament, according to the Lancet.• The Parliamentary resolution suggests that the EMEA

should be moved from its present location withinthe Directorate General Enterprise, into the EC’sPublic Health Directorate. "Such a move wouldensure that any proposed legislation would beconsidered in light of its potential impact on health,and that the policies applying to medicines would besynergistic with strategies that apply to other healthsectors", says the Lancet.

• There should be no direct financial relation betweenEMEA and industry, as such financial ties mayprevent the Agency from achieving its mainobjective.

• Pharmaceutical companies should contribute to thecosts of the national pharmacovigilance systems, inproportion to volume sales. Currently, it is proposedthat they contribute according to the net annualprofits generated by the sale of the new medicinalproduct.

• Inconsistency within the text of the resolutionregarding the risk-benefit balance of new drugs mustbe resolved.

• Recommending that drugs be approved only wherethe underlying clinical trials meet ethicalrequirements "may be the basis for rejecting trialsaiming at demonstrating equivalent or non-inferiorefficacy of new drugs compared with those alreadyavailable, without proving additional advantages interms of safety, tolerability, convenience, oranything", states the Lancet. It adds that such trialsare unethical, as randomisation exposes patients tounknown risks, yet they presumably only offer whatother treatments would provide anyway.

• All companies, regardless of size, should be obligedto use the centralised procedure, in order to "avoidthe risk of big companies setting up small subsidiariesto secure lawful access to the mutual recognitionprocedure", says the Lancet.

• The proposed drug price structure should be madepublic.

• Access to affordable generics could be underminedby several points in the resolution, such as the3-year data protection granted for switching to over-the-counter status.

There are also several other points that are worthreconsidering, according to the Lancet. The legislation isscheduled to undergo a second reading in Parliament."Pressure from patients, consumers, and health-careprofessionals aimed at public-health objectives would beappropriate and timely in the present situation", theLancet concludes.* see Inpharma 1363: 3, 9 Nov 2002; 800901940

Garattini S, et al. Light and shade in proposed revision of EU drug-regulatorylegislation. Lancet 361: 635-636, 22 Feb 2003 800907240

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Inpharma 1 Mar 2003 No. 13761173-8324/10/1376-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved