Applied Clinical Trials
New legislation for transparency - currently underway for clinical trial data, national drug pricing rules, and personal privacy - is clearly not enough to satisfy the transparency hawks in Europe.
New legislation for transparency - currently underway for clinical trial data, national drug pricing rules, and personal privacy - is clearly not enough to satisfy the transparency hawks in Europe. Transparency is also at the heart of a new initiative adopted this summer under the grandiose banner of 'Guiding Principles of Good Governance in the Pharmaceutical Sector.'
The principles, developed over the last couple of years under the aegis of the European Commission, are designed to govern interactions between healthcare professionals and patients’ organizations, regulatory authorities and the pharmaceutical industry. The ambition is expressed in equally grandiose terms: to satisfy "the need to go beyond bilateral relationships and to address the quintessential role of good governance in the pharmaceutical sector."
What this will mean in reality is that the drug industry will disclose more about its promotional practices, and anyone susceptible to or targeted by such practices will also declare anything they receive that might be considered an inducement.
The drug industry has committed itself to new standards on gifts and funding. A code adopted in parallel by companies in Europe will require them to document and disclose details of payments to healthcare professionals and associations - along with names of beneficiaries, the value transferred, and the type of relationship, such as consultancy fees, payment for travel, or congress fees. It covers donations and grants, contributions to costs related to events, including sponsorship of attendance, and research and development transfers of value.
Doctors’ organizations and patient associations have signed up to similar aspirations. The European Patients Forum, one of the organizations closely involved in the platform that developed the guidance, says "Transparency is a core value of EPF, and also a criterion for membership," and "we have strongly encouraged all EPF members to read these Guiding Principles and ensure that our members’ organizations are also leading good practice in ensuring patient groups work to the highest standards of transparency, independence and ethics."
The give-away is the concept of "encouragement." The principles are only guidance. They are voluntary and non-binding. And although the pious hope is expressed by the principles' creators that national and sectoral compliance will follow, the effectiveness or otherwise of the initiative will be revealed only in what happens on the ground over coming months and years. Even within the drug industry, which has been one of the principal drivers of this exercise, the first disclosures will not take place until 2016.
The medicines sector will consequently remain under suspicion, and its efforts at appearing whiter than white will be viewed as more empty rhetoric until there is real delivery on all these claims. Not for nothing does EPF admit: "We can anticipate continued scrutiny in the way that we all work with industry and other health stakeholders."