Special Report by EurActiv*, 5 October, 2012 – The European healthcare system is struggling to cope with low levels of transparency and trust in the pharmaceutical sector, according to 97% of doctors, industry professionals and policymakers attending a workshop at the Gastein Health Forum yesterday (4 October).

“North Korea would be proud of you!” said workshop moderator John Bowis, a former MEP and president of stakeholder group Health First Europe, after conducting the straw poll in a session addressing transparency between the public, health professionals and industry in the Austrian resort.

Thomas Heynisch, an official with the EU executive’s enterprise department, told delegates that the Commission would publish new corporate social responsibility guidelines in early 2013 to tackle issues of trust and ethics in the pharmaceutical sector, and access to medicines in Europe.

This was prompted because the EU executive believed there was “a level of mistrust, particularly between public authorities and the pharma industry.”

“The Commission wants to move beyond codes of conduct, but not to introduce new legislation, rather we want guiding principles which can be a source of inspiration for those working within and beyond the pharma industry,” Heynisch said, explaining that enforcement of the new guidelines will be carried out at national level.

Industry Acknowledges Problem

Richard Bergström, director-general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), agreed that transparency and trust were an issue, but that the pharmaceutical industry enjoyed levels of trust that exceeded other professions.  He concurred that “policymakers do not have that level of trust with us.”

Referring to new rules which came into effect last month – requiring the European Medicines Agency (EMA) to disclose the details of clinical tests for drugs – he said: “There is a lot of raw data that will be in the public domain, and industry and the public need to find ways of navigating this so that it makes sense for all parties.”

Bergström added that EFPIA is also in dialogue with the medical profession to help foster public trust. “We have not in the past been open enough about the number of people involved in the testing of medicines,” Bergström added, explaining that the name of a single professor on pieces of scientific research sometimes gave the impression that only one person was responsible for the entire study.

Bridging the Divide between Patients, Industry

Academic journals were another area where he saw the need for change, explaining that sponsored research should be clearly indicated, and not marked with a barely visible footnote.

“Bad data hits the headlines,” Mary Baker, the president of patients’ group the European Brains Council, told the meeting. She said that the reason there were so many bad news stories was that patients and industry are too separated along tribal lines.

“We are like two houses apart, and in the middle is a ditch into which gets thrown a lot of rubbish,” Baker said. She appealed, as a first step, for patients who are involved in clinical trials to be involved in longer-term dialogue with pharmaceutical companies.

“It should not be too much for industry to write to those whom they have used in their trials to explain to them what the outcome of these trials was, and to engage in a more meaningful dialogue that would enable more openness about the results to emerge,” Baker said.

Doctors Should Disclose Interests

Edwin Borman, secretary-general of the European Union of Medical Specialists, told delegates that doctors such as himself addressing conferences should be obliged to fully disclose any corporate or academic affiliations before adopting public stances.

Borman, who is a member of a working party on transparency for the European Commission, said that integrating corporate social responsibility procedures into the fields off medical research, education and training would go a long way to answering concerns about transparency and trust swirling around the industry.

Borman said that he had particular concerns about the awarding of credits for continuing education accrued at medical conferences, since often these are sponsored in less than transparent ways.

Careful of Pendulum Swinging Back Too Far

“We want to know whether there is any inopportune influence. We want to know that the legal competencies have been addressed and that there is no room for bias,” he added.

Trevor Jones, an industry professional working for several pharmaceutical companies and former head of the Association of British Pharmaceutical Industries, said that the new EMA rules requiring disclosure of vast amounts of raw data signified that “the pendulum has swung back too far”.

Whilst he acknowledged that industry must deal with issues of trust, Jones said that the data would be available to anyone, and was therefore open to abuse from mischievous litigants and unscrupulous media interests.

The cost of gathering up and processing the material would also represent a burdensome cost to industry, Jones told the workshop.

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2012 Human Wrongs Watch