by Stefan Gijssels

Transparency will demonstrate how the interchange between pharma and healthcare adds value and speeds the translation of research into new medicines. It will also provide the public with information to which it should have access, says Stefan Gijssels

StefanGijssels

Transparency “is really at the heart” of Janssen’s business model, says Stefan Gijssels, the company’s vice president of communication and public affairs, EMEA. “We are evidence-based; science is our business; acknowledgement of the data we generate is evidence of the quality of our products.”

To gain this acknowledgement, everything that Janssen does, “should be able to be assessed by the outside world,” Mr Gijssels says.

Such scrutiny will highlight the industry’s significant contribution to healthcare, and underline the important place that the free exchange of information between industry and healthcare professionals has in advancing the development of new and better medicines.

In addition, Mr Gijssels notes,
“Much of what the industry does relies on money from the tax payer:
there is a legitimate right to non-confidential transparency information.”

At one level, the pharmaceutical industry, as one of the most heavily regulated industries, has a long history of disclosure, with a requirement to make all data on its products available to expert evaluators.

However, it is also the case that other interactions have not always been so open, says Mr Gijssels, who acts as chair of EFPIA’s Trust, Reputation and Compliance Policy committee.

Now, a culture of openness is sweeping society as a whole. Whereas previously responding to this would have presented a huge bureaucratic overhead, the availability of ICT tools means it is practical to make information publicly accessible.

Pointing to the chemicals sector, Mr Gijssels notes that greater openness on emission data has diminished conflicts with environmental groups. There is no longer a generalised mistrust, he believes. “Discussions are now focussed on the facts, not on assumptions and emotions.”

And while there have been instances of malpractice in the pharmaceutical industry, “turning on the light” and disclosing all financial relationships, will demonstrate these are indeed exceptions today.

Implementing the code

While it is good to have European code of practice, as laid down by EFPIA, privacy laws are national. As a result Janssen is obliged to implement financial disclosure on a country-by-country basis.

However, the company will seek to ensure all its information systems are aligned. “It’s easy from the outside to say this, but it requires similar definitions: What is fee for service? How do you define medical education? What is research? There may be different labels by country,” Mr Gijssels notes.

Behind the scenes, a lot of work is going on to meet the disclosure requirements. This is informed by the effort that has gone into complying with the Sunshine Act in the US.

There is a key difference of course, in that the Sunshine Act makes financial transparency a legal requirement, whereas EFPIA is unrolling a voluntary code. “We have to reach out to physicians individually; in that sense it is not an easy exercise,” says Mr Gijssels. It requires a concerted effort, with everyone trying to move as one across Europe, despite differences in national legislation.

Disclosure underpins collaboration

Mr Gijssels acknowledges there may be some hesitance on the part of clinicians about payments being catalogued on a public, searchable, database, saying, “Therefore it is critical that we communicate well about why these collaborations with physicians are taking place and what value they bring to patients”.

At the same time as entering an era of greater openness, we also live at a time when collaboration between academics, clinicians, companies, patient organisations and public health experts is more essential than ever in the development of new medicines. You cannot collaborate unless there is trust, and you cannot trust each other without transparency. That also includes clarity on the real value and limitations of new medicines.

He also believes data transparency will be a one day wonder for the media. “The first time it’s published, they’ll say, ‘Is that it? There’s not much of a story there.”

Stefan Gijssels is the Vice-Chair of the Trust, Reputation and Compliance Policy Committee (TRCPC) of EFPIA and VP Communications & Public Affairs, EMEA at Janssen, Pharmaceutical Companies of Johnson and Johnson