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EC slammed for pharma oversight changes

Organisations criticise decision to transfer responsibility for pharma policy from health to industrial department
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A proposal to transfer responsibility for pharmaceutical policy at the European Commission (EC) from health to the industrial directorate has been greeted with consternation by public health activists.

The plan - unveiled by EC President-elect Jean-Claude Juncker as part of his appointment of new Commissioners - is "promoting profit over public health," according to the European Public Health Alliance (EPHA), which expressed its "alarm and disbelief" at the move.

Juncker wants responsibility for pharma to move away from the Directorate General for Health and Consumers (DG Sanco) - under Vytenis Andriukaitis - to the new DG for Internal Market, Industry, Entrepreneurship and SMEs, which will be run by Elžbieta Bieńkowska.

[This] threatens Europe's ability to prepare for major health crises such as outbreaks of infectious diseases and health threats arising from climate change

European Public Health Alliance

The move includes responsibility for the European Medicines Agency (EMA) and comes five years after responsibility for pharma moved from industry to health. At the time, the transfer of oversight was hailed as a triumph for common sense as it placed medicines policy within the remit on healthcare whilst separating it from commercial interests.

The EPHA argues that this is a retrograde step that "threatens Europe's ability to prepare for major health crises such as outbreaks of infectious diseases and health threats arising from climate change, whilst putting the public interest behind the drive for profits in drug authorisation procedures."

That sentiment has been echoed by Health Action International (HAI), which said it was appalled by an "opaque and unjustified decision" that will put "the commercial, profit-driven interests of the pharmaceutical industry, rather than patients and consumers, at the heart of European policymaking on medicines."

HAI is particularly concerned about the fate of the EMA suggesting that the shift could jeopardise ongoing efforts to make data from clinical trials more transparent and available to independent researchers, although the regulatory has insisted the change will not lead to any deviations in its policy.

The EMA is in the process of finalising its plans for clinical transparency after the European Parliament voted by a large majority to adopt the regulations which will make it a legal requirement for pharma companies and other researchers to publish full trial data results, although this will only apply to new drugs and not those already on the market.

UK MEP Glenis Wilmott, who was a pivotal figure in ushering the clinical trials regulation through the European Parliament, said she is equally concerned.

"When I was negotiating the transparency laws for clinical trial results, it was DG Enterprise that wanted to water the rules down," said Wilmot. "Now they will be overseeing the EMA as it implements the transparency regime, which is frankly concerning."

Transparency campaigner Ben Goldacre - author of Bad Pharma and a key figure in the AllTrials campaign - tweeted that the proposal "will be bad" and "sends a very strong signal about who your medicines regulator works for," adding: "Shame, EC."

 

EPHA president Peggy Maguire said that "it is disappointing that President-elect Juncker believes these objectives fall a pale second place to appeasing big business,” adding: "It sends a terrible message during times when criticism is being levelled at Europe."

Consumer organisation BEUC also expressed its concerns about the transfer, saying that the primary brief of the DG is "to promote the competitiveness of these industries, not the health of consumers."

The proposal still has to clear a vote in the European Parliament, and both the EPHA and HAI have urged MEPs to block the transfer.

Article by
Phil Taylor

15th September 2014

From: Regulatory, Healthcare

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