Dec 01, 2009
By Pharmaceutical Technology Editors
Volume 21, Issue 12

UK says no to DTC advertising

(Brand X Pictures/Getty Images)
Responses to EC proposals that would allow drugmakers to disseminate certain information on prescription-only medicines directly to patients in the EU have been published by the UK's Medicines and Healthcare products Regulatory Agency (MHRA). For the most part, the responses support the initiative, but also call to uphold the current ban on directtoconsumer advertising (DTCA).

The consultation, conducted by the MHRA, began in May 2009 to assess UK public opinion for the information provision proposals, which are part of a wider pharmaceutical package that was announced by the EC in December 2008. Although the proposals would open up certain communication channels, including the internet and certain health-related publications, for the industry to provide factual and non-promotional information on their medicines, the ban on DTCA would remain.

For the most part, participants agreed with the UK government, which is supporting the proposals on the basis that they will "increase the amount of information available to patients and provide a regulatory framework that is not overly burdensome". In its response to the proposal, Roche explained that: "more relevant and accurate information will only serve to support the advancement of patient empowerment and understanding about medicines and their management." UKbased Epilepsy Action also added that: "these proposals, if followed through, have the potential to improve public health."

According to the MHRA, there was "overwhelming support" for the UK government to maintain the ban on DTCA, as well as support for maintaining the ban on television and radio advertising. The agency said that the view of the British Medical Agency (BMA), which said: "The BMA welcomes the EC's decision to prohibit the provision of information via television and radio. The BMA has voiced grave concerns on this during the past 2 years and is pleased that the EC has taken action to protect patients from the confusing mix of information and advertising that would have resulted if information via these forms of media was permitted", "echoed" the concerns of many of the respondents.

Some respondents, however, believe there is a need for technological innovation and suggested that there may be circumstances, such as the emergence of a counterfeit product, when broadcast media would be appropriate. Interactive digital television was also suggested, as the viewer would have to choose to go through several steps to access the media rather than it being unsolicited.

Another key element of the EC proposal is ensuring that the information is effectively monitored and controlled. This could be achieved through various options including: regulation by national authorities, industry selfregulation or coregulation where each member state establishes a national co-regulatory body. The majority of respondents to the MHRA consultation supported a selfregulatory approach underpinned by national enforcement provisions; however, there were some arguments against this that centred around the industry not being trusted.

Additional concerns were also raised against what constitutes factual and non-factual information. The BMA explained that the definitions of 'advertising' may differ between EU member states, which could result in loopholes to the DTCA ban.

The MHRA has said that it will now take a number of the comments forward to a European level. Before the proposals laid down in the pharmaceutical package can be translated into law, they must first be discussed by the European Parliament and the Council of Ministers.


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