Monday, October 31, 2011

In Rejecting Proposal, EU Dashes Drugmakers’ Hopes of Having a Voice

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Casey Ferrell is a research analyst at Cutting Edge Information. He will be guest blogging at IIR’s upcoming ePharma Summit 2012 (February 6-8, 2012 in New York City). You can find him on Twitter or over on his company’s blog.

Three years ago, there was a glimmer of hope for drugmakers in the EU to be able to publish information about their products. But in early October the European Commission, the executive arm of the EU, flexed its muscles and dashed any hope that the governing body would relax the rules restricting pharma’s contact with consumers.

In 2008, the European Union’s Pharmaceutical Forum introduced a proposal to reform marketing rules and effectively allow pharma companies in Europe to circumvent the existing ban on DTC advertising. In the face of ensuing backlash from consumer protection agencies and patient and physician advocacy groups, the Commission eschewed it in favor of a milder one that would allow drugmakers to communicate to the general public in written form and on the Internet, primarily in selected media such as health publications.

Earlier this summer, the Commission said it would review the proposal. In the three years since the proposal was brought up for consideration, turnover on the Commission and a shift in the responsibility for pharma policy from the Commission’s industry division to its health division helped create a less receptive environment for the “deregulation” of pharma marketing and tempered any optimism for change.

However, the final ruling went beyond rejecting the original proposal and ensured that pharma companies would not be allowed to disseminate information about drugs and their indications beyond a narrow set of circumstances. In other words, the already restrictive regulatory environment on pharmaceutical communications got even more so. Lynne Taylor of PharmaTimes described the tougher measures:

They also propose that:

  • only "certain" information on prescription drugs would be permitted, such as that on the label and on packaging leaflets, plus information concerning prices, clinical trials or instructions for use;
  • information on prescription-only drugs would be permitted through limited channels of communication, such as officially-registered internet websites or printed information made available when specifically requested by consumers. Publication in general print media would not be allowed;
  • the information must fulfill recognized quality criteria — it must, for example: be unbiased; meet the needs and expectations of patients; be evidence-based, factually correct and not misleading: and be understandable; and
  • as a general principle, information which has not previously been approved will need to be verified by the competent authorities prior to dissemination.

Although the development is not surprising to most in the industry, there was a hope that the Commission would allow the previous proposal to stand, giving pharma an opportunity to provide information about their products in general media. The industry has long claimed that they need the latitude to provide reliable, accurate information about their drugs to counteract the abundance of misinformation available. Ben Comer in his PharmExecBlog quoted Ian Read, Pfizer’s president and CEO, as describing DTC advertising a “fundamental right in the U.S.,” and its absence “leads to ignorance and the inability to judge.”

The EU is certainly not the US, but do pharma companies have a “right” to promote their products to consumers? Would allowing pharma companies to communicate more freely in Europe lead to better information for consumers and better health outcomes? Or is it a slippery slope that leads to DTC “in disguise?” Perhaps there is a middle ground short of DTC but that affords pharma something more than zero communication. What are your thoughts?
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