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Greater openness required by new European laws

Published on 31/03/05 at 11:50am

Pharmaceutical companies will be obliged to share safety data more openly from November with the adoption of new pan-European laws.

The MHRA says the UK pharma industry is already practising many of the European directive requirements but says the legislation will formalise this responsibility.

"We want to appear more transparent and these changes will hopefully explain how and why approval is given to each drug. Pharmaceutical companies had the provision to undertake these measures before but we want to strengthen this obligation," said an MHRA spokesman.

Key stakeholders, including patient groups, industry and the DH will take part in a 12-week consultation on how the EU directive should be translated into UK law by 30 October.

The MHRA has indicated that the proposals aim to safeguard public health without hindering pharmaceutical advancement by communicating the information to healthcare professionals and patient groups.

The EU laws require uptake in all member states in the following areas:

  • Publishing of assessment reports on new medicines
  • Risk management plans for medicines at time of licensing
  • Obligation on industry to inform MHRA of safety impact issues
  • The harmonising of data exclusivity periods across EU and provision of rapid generic entry into the market

The European Directive allows national regulators some latitude in how the legislation is interpreted, but the UK regulator hinted it would be taking a robust approach to the issue, revealing it wanted to "toughen up" its approach to regulation.

"Things have not changed in practice but companies who want to sell drugs will be required by law to inform the MHRA of key issues," added the spokesman.

The new laws provide the MHRA with an opportunity to tighten up its regulation of the sector following intense criticism over the last two years, particularly relating to its investigation into the safety of SSRI antidepressants.

An investigation by the Commons Health Select Committee into the pharmaceutical industry and its relationship with the MHRA is expected to publish its conclusions shortly, and may recommend further measures to prevent safety scares such as those surrounding SSRIs and Vioxx.

Lord Warner, the DH minister, told the committee that more robust post-licensing surveillance measures were now being considered by EU governments.

The MHRA has already strengthened its regulation by adopting early a number of provisions of the Directive, including the user testing of patient information leaflets and a provision to encourage wider availability of OTC medicines, with the former becoming a statutory requirement for pharma companies in the summer.

Another key piece of legislation, the Freedom of Information Act is also opening up formerly confidential MHRA documents and communications.

These include minutes from a meeting of the Committee on Safety of Medicines requested by The Guardian newspaper in February which show the experts had recommended AstraZeneca's Crestor should not be granted marketing approval in a high dose form.

In January 2003, the committee recommended that patients should be started on a 5mg dose rather than the 10mg one preferred by AZ, and that the highest dose proposed, 40mg, should not be allowed.

EU-wide consultation eventually permitted the 40mg dose, but safety concerns have led the EMEA to recommend reserving it for exceptional cases.

The FDA updated its guidance recently on the drug, issuing similar precautions about the 40mg dose and other revisions to the product labelling, but ignored calls from watchdog Public Citizen for its withdrawal.

Related articles:

Regulators tighten up Crestor's European prescribing

Thursday , June 17, 2004


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