The UK’s medicines regulatory body has launched a consultation on the European Commission’s plans to change the rules on the information that drug companies can provide to patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking views from the public on the UK government’s response to the proposals and says it will also hold face-to-face consultations with patients, healthcare professionals and industry stakeholders.

The EC wants to create a framework for the pharmaceutical industry to provide factual, non-promotional information on their medicines to the public based on a set of quality criteria. Information will not be allowed to be provided via TV or radio, but allowable communication channels will include the internet and health-related publications. It proposed that the current ban on direct to consumer advertising should remain.

The UK government is backing the creation of a framework and the quality criteria proposed by the Commission and has welcomed the EC’s plans to maintain the ban on direct to consumer advertising. It has supported a mixture of self-regulation underpinned by statutory processes for enforcement which it says fits with the established UK system of self-regulation for medicines advertising.

The MHRA said the EC had calculated the potential benefit to the UK of the proposals, in terms of disease prevention, better awareness of symptoms, better interaction with health professionals and better compliance, at £525m to £630m per year.

It estimated the one-off costs for the industry of producing the information at £2.6m to £21.4m with annual costs to the healthcare system of £28m to £74m and an annual cost to the pharmaceutical industry of £3.5m-£28.7m for information provision.


The MHRA consultation runs until 14 August. Changes are not expected to come into force until 2011-12 at the earliest.