“This is the beginning of a conversation”

Richard Bergström, Executive Director of EFPIA launched pharmadisclosure.eu this week, committing the industry to be “absolutely transparent” about its financial relationships with healthcare professionals. Work is in hand to set up registries of payments or other forms of support. Now it is time to communicate with three million healthcare professionals in Europe, to explain how this will be put into practice.

The European pharmaceutical industry has launched a campaign to publicise its new code on disclosing financial relationships, explaining the systems that are being put in place within companies and at a national level, what will be involved for healthcare professionals and healthcare organisations, and opening a public debate about the objectives of the disclosure initiative.

Richard Bergström - Executive Director, EFPIA

Richard Bergström, EFPIA

“We as an industry have said we will be absolutely transparent about our relationships with healthcare professionals. But we have only just begun to communicate with the three million medical professionals in Europe about how this will be put into practice,” said Richard Bergström, Executive Director of EFPIA.

The launch of pharmadisclosure.eu, “is the beginning of a conversation,” Mr Bergström told one hundred delegates representing the medical profession, pharmacists, patient groups, industry bodies, medical charities, pharmaceutical companies and policy makers, at a meeting held in Brussels this week, as the website went live.

The pharmaceutical industry has not been good enough at explaining the central role that its relationship with healthcare professionals plays in bringing new medicines to patients. As a result, transfers of value have not been seen in context. As Mr Bergström noted, for people that understand the role that the interchange between pharmaceutical companies, academics and clinicians plays in developing new treatments – for example, the parents of children who suffer from rare diseases – criticism of the industry is misplaced.

pharmadisclosure.eu is, “about talking about what we do in research and with physicians,” Mr Bergström said. Such full transparency is the route to earning trust and building the reputation of the industry.

EFPIA has been working for three years to set out guiding principles and to put in place its ‘Code of Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations’. This was agreed in July 2013, and preparations are in hand to implement the code for data collection which begins in 2015, leading to public disclosure in 2016.

However, there is still a “big journey” to ensure healthcare professionals understand the objectives and to bring them on board, said Mr Bergström. “We need to get buy-in and there will be a debate in the press and national parliaments.”

“I look forward to working with all of you to bring in transparency, so we can get on with doing what we should be doing, which is bringing drugs to patients.”

Concerns of healthcare professionals

Inevitably, healthcare professionals have some reservations about payments they have received being listed on public, searchable databases, with representatives of clinicians at the launch meeting suggesting the pharmaceutical industry is seeking to transfer its bad reputation to the medical profession. There are also concerns that doctor-patient relationships could be adversely affected.

Michel Dutrée, Nefarma

Michel Dutrée, Nefarma

However, the example of the Netherlands, the first country in the world to establish a public registry, indicates this concern is misplaced, according to Michel Dutrée, Director General of the Dutch industry body NEFARMA. With the support of the Ministry of Health, the Dutch system went live in 2013, disclosing 7,500 financial relationships, under which payments totalling €33 million were made in the 2013 and 2014 reporting years.

The average payment received by the 2,000 healthcare professionals that are listed is €2,250, while 1,200 institutions received an average of €25,000.

When the registry was first published in 2013, there was one negative press report, Mr Dutrée noted. When it was published for the second time in 2014, there was a single press report, and that was positive. “There was no transfer of bad reputation,” he told the meeting.

Negative stereotypes

For Paweł Sztwiertnia, General Director of INFARMA, the industry association in Poland, financial transparency is the way to dispel the negative stereotyping in which the media characterises the relationship between pharmaceutical companies and healthcare professionals as corrupt. “The initiative will change this to a fact-based discussion about the value of the relationship between the industry and doctors,” Mr Sztwiertnia said.

Paweł Sztwiertnia, Infarma

Paweł Sztwiertnia, Infarma

The industry needs to be in dialogue with doctors and patients in order to develop new medicines. “I strongly believe this is in the public interest, not just in the industry’s interest,” said Mr Sztwiertnia.

But it is also the case that while physicians surveyed by INFARMA are in favour of the financial transparency initiative, there is a “big anxiety” associated with the publication of their names and the payments they have received.

INFARMA is consulting widely, talking to presidents of scientific associations, interacting with physicians and attending medical conferences, to talk about the disclosure code. Most healthcare professionals are pragmatic, said Mr Sztwiertnia. “They recognise this is going to happen. But they still need to be convinced [the exposure] will be okay.”

Consent requirements

Similarly, the Association of the British Pharmaceutical Industry (ABPI) recently embarked on a programme of consultation with healthcare professionals. “Our ambition is to co-create [a central registry] in partnership with the medical community, so their support is important,” said Maggie Campbell, Reputation, Policy and Strategy Lead at ABPI.

As it progresses the technical side of setting up the register, one of the fundamental issues the ABPI needs to address is getting the necessary consent from physicians to disclose their information. The ABPI had drawn up a model clause for use in future contracts, stating that transfers of value will be published and asking for consent.

Maggie Campbell, ABPI

Maggie Campbell, ABPI

“As yet, we have no understanding of what percentage of healthcare professionals might withhold consent. If it’s high that could undermine [the disclosure code], demonstrating why we need to work together with the medical profession,” Ms Campbell said.

The aim is to shift perspectives, so that like not wearing a seatbelt, it would be socially unacceptable not to consent to disclosure. “We need leadership from the industry and healthcare professionals to drive this cultural change,” said Ms Campbell.

ABPI is now engaging one-to-one with medical bodies in the UK, to talk about communications programmes to drive awareness of financial disclosure down to the level of individual practitioners.

The cacophony of disclosure

The concerns and anxieties of the medical profession need to be viewed from a wider perspective than the EFPIA financial disclosure code alone, said Robert Schaefer, Senior Project Manager at the European Society for Medical Oncology, which represents 7,000 members across Europe.

Robert Schaefer, ESMO

Robert Schaefer, ESMO

Increasing public scrutiny and suspicion of relationships with commercial organisations has sparked across the board transparency initiatives, and physicians are confronted with a range of mandatory and self-regulatory disclosure requirements. But with no evidence-based standards for assessing the potential risk of undue influence or bias, these reporting requirements are based on a variety of risk perceptions. “That’s what makes physicians nervous,” said Mr Schaefer.

The emerging “cacophony of conflict of interest disclosure” is in danger of defeating the object, making matters less, not more transparent. This calls for harmonisation of disclosure codes, however, at present there is no single process or common framework in sight, Mr Schaefer said.

In response, Richard Bergström pledged to do everything possible to avoid duplication. “There may be some slight differences across countries, but this is mainly a headache for the industry,” he said. “I’m very happy this discussion has started with healthcare professionals; I’m committed to working together with all stakeholders on full transparency,” Mr Bergström concluded.