Transparency is the goal as Europe goes live on payment disclosure

LONDON – Websites publishing details of payments from pharma companies to health care professionals have gone live as Europe presses the button on its version of the U.S. Sunshine Act, and makes information on money paid to individuals available for public scrutiny for the first time.

With the exception of Denmark, France and Portugal, the requirement to disclose does not have the force of law. As a result, pharma companies that are responsible for collecting the information must get consent from individual health care professionals and organizations before publishing it.

In the absence of a legislative imperative, the impetus to disclose has been driven by the European Federation of Pharmaceutical Industries and Associations (EFPIA), which numbers the major pharma companies and 33 national industry bodies amongst its members.

That will provide comprehensive coverage across Europe, said Andrew Powrie-Smith, who is responsible for implementation at EFPIA.

However, Powrie-Smith acknowledged that the need to get consent of individual health care professionals will result in differences in the level of compliance from country to country.

"There are differences in culture, differences in privacy law – Germany for instance has very strong laws – there are different socio-economic conditions in different countries, so inevitably there will be variation," Powrie-Smith told BioWorld Today.

There have been many formal statements and letters of support from professional bodies. "To my knowledge there is no health professional organization . . . saying this is not a good thing to do," Powrie-Smith said.

In addition to variation in the level of consent from health care professionals, there also are differences in the way information is published. In some countries, including the Netherlands and the U.K., there is a central database; in others the data are accessed via the websites of individual pharma companies.

The guidelines laid down by EFPIA set a minimum standard for what information is required. "The standard articulates what payments are to be disclosed. The only variation is in places where there is legislation, where there may be different categories," said Powrie-Smith.

In the U.K., the Association of the British Pharmaceutical Industry turned on its centralized database at 2 p.m. BST/ 9 a.m. EDT on June 30, disclosing aggregate spending for 2015 of £340.3 million (US$450 million), by 109 companies.

Of that, £229.3 million (67 percent) was for clinical trials and essentially went to the National Health Service. There are no details of the institutions that received the money in the ABPI disclosure database, since the information is available from other sources.

The remaining £111 million, which was paid out to individuals as fees for services and consultancy, for attending conferences, sponsorship of events, and donations and grants, reads across to encompass the same activities that are covered by the Sunshine Act in the U.S.

In total, 70 percent of recipients of the £111 million gave consent for the payments they had received to be disclosed.

However, that 70 percent only accounts for 48 percent of the payments by value. The highest single payment received by an individual that is recorded in the database is £98,000.

Mike Thompson, CEO of ABPI, said there are people who received higher payments but they did not give consent for their information to be disclosed. He is hopeful that more medics will choose to give consent once the database is fully up and running and the novelty has worn off. "I hope those who did not disclose reflect on their positions and do so next year," he said.

Nevertheless, ABPI is "proud of the figures," Thompson said. "This is a milestone day for the industry. . . . The industry is on a journey of change to more transparency, to help the public understand what we do and why."

CHANGING ATTITUDES

The whole process of developing drugs, from early discovery, to clinical trials and writing patient leaflets, involves pharma working in partnership with health care professionals. "The story today has never been told to the British people before. We don't do all this on our own," Thompson said.

"Doctors and nurses and pharmacists give up time, and we think it is right and fair we should pay them."

Although EFPIA sets standards for disclosure, companies are collecting data in slightly different ways. As a result, although the data are searchable, ABPI has had to provide guidance notes for analyzing them and understanding what conclusions can and cannot be drawn.

Notably, some individuals have given partial consent, allowing payments from one company but not another to be disclosed. However, ABPI said that number is relatively low.

The largest total spend by any company for both clinical research and fees for service, etc, was £41.9 million by Astrazeneca plc. The smallest was £266. Average spend per company was £3.1 million. Of companies that spent more than £5 million, the majority was for clinical research.

As for what patients and the general public are to make of the data, Thompson said, "The people who are paid the most are global experts. . . . We should be very proud about the role British doctors play in the development of new medicines. . . . It has to give patients a lot of reassurance that they get access to experts."

Similarly, Powrie-Smith said EFPIA's members have been publishing aggregated figures of payments for the past few years and the additional level of detail has been "pretty well" received in general. "There is understanding of the need for collaboration between the people who make the medicines and the people who prescribe them, and the reaction has been positive."

While Powrie-Smith agreed there is a risk that some medics who do not want to disclose will stop engaging in collaborations, he said he also thinks attitudes are changing, and transparency in the relationship between pharma companies and the medical profession is increasingly viewed as necessary and positive.

"The aim is not to shame; the aim is to make sure we do whatever we can to make the relationship as transparent as possible, to get consent and get the information in the public domain in a way the public can access it," Powrie-Smith said.

It will be important to keep raising awareness of the need for cooperation between the industry and health care professionals. "We've gone from a standing start, where there was zero data in the public domain, to a leap in what is publicly available about these relationships.

"That is the starting point. We have to work with health care professionals and others to ensure there is understanding of why," said Powrie-Smith.

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