by Holger Diener
Over the past ten years pharmaceutical companies in Germany have proactively responded to the general trend towards greater transparency that has swept across public and corporate life. This puts the industry on the front foot in implementing the new financial disclosure code, says Dr Holger Diener, Managing Director, Association of Voluntary Self-Regulation for the Pharmaceutical Industry
Pharmaceutical companies in Germany are making significant progress in complying with the European Federation of Pharmaceutical Industries and Association’s voluntary code on disclosure of transfer of value.
Nevertheless it is important not to underestimate the challenge involved in putting the systems in place to collect, check and publish the data. “Overall companies are very positive about progress but there is a significant amount of work to do,” says Dr Holger Diener, Managing Director of Freiwillige Selbstkontrolle für die Arzneimittelindustrie (FSA: Association of Voluntary Self-Regulation for the Pharmaceutical Industry).
There has also been positive feedback from the relevant stakeholders and the general public in Germany, with recognition that financial disclosure is a “large next step” in the move towards transparency. Although it is a self-regulatory approach, the FSA would also welcome legislative backing for the initiative
A legal requirement would be helpful because it would cover the whole sector, ensuring complete cooperation, and removing constraints in collecting information imposed by data protection laws. “Overall though, this is not an issue in the political arena so far. A couple of politicians have referenced the US Sunshine Act, but it’s not a broad discussion,” says Dr Diener.
In any case, the German pharma industry wants to be a role model, Dr Diener says. “We don’t want to wait for legislators; we want to show the outside world we have an open approach.” He believes this stance has the support of the medical profession as whole, despite varying opinions on the details of how disclosure should be handled.
“We are going to a lot of conferences and informing doctors and healthcare professionals about the system we are putting place,” Dr Diener said.
Whatever reservations there may be, Dr Diener believes there is widespread appreciation of the importance of the relationship between pharma and healthcare professionals. “I’m sure most people would say, ‘Yes, it is important’. Certainly we as an industry need the expertise of doctors and there is general recognition that this is of benefit to patients. There is a high level of cooperation and we want to be open about it.”
Dr Diener points to rules on the disclosure of payments and other support from pharmaceutical companies to patients’ groups, introduced in 2009, as an example of the value of transparency. “Before there were criticisms about the interaction between pharma and patients’ organisations, claiming companies were attempting to exert influence. Once disclosure measures were in place, the discussion stopped because it was obviously the influence was exaggerated,” he says.
While concern has been expressed elsewhere that making information on payments to individual physicians could affect the doctor/patient relationship, Dr Diener says this has not been an issue in Germany. “However, we need to be aware of the possibility and be ready to put the figures into context.” The reaction to the first publication of data under the US Sunshine Act will provide guidance, Dr Diener believes.
The public launch of the Sunshine Act Open Payment database in the US has been affected by problems with the integrity of data – with some doctors recorded as having received payments they have not.
“That’s been an important message for us. We have got to be sure the data are accurate. This is quite a challenge for companies. Larger multinationals have systems in place in the US and these need to be synchronised with systems in Europe to ensure all the information is correct and complete, with no duplication,” Dr Diener concluded.