Clinical & Regulatory

Clinical & Regulatory

Proactive disclosure – a model for future openness in medtech



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What would a voluntary submission of financial and partnership data by the medtech industry look like and what could it achieve? Sophia Ktori finds out how Belgium has adopted the European Federation of Pharmaceutical Industries and Associations (EFPIA) code

EFPIA code

‘Medtech and pharmaceutical companies have always maintained close relationships with the healthcare professionals (HCPs) and healthcare organisations (HCOs) that are at the front line of patient therapy,’ points out Dr Kristel De Gauquier, spokesperson for the betransparent.be initiative and Medical Director at pharma.be, Belgium’s innovative pharmaceutical association. ‘There are very real benefits to transferring knowledge in both directions. The industries rely on the healthcare providers for real-world feedback, insight and expertise that will inform and drive the development and appropriate use of new, more effective medical devices, technologies and drugs. Physicians and healthcare organisations are ideally placed to take part in or spearhead clinical trials, and industry gains valuable knowledge from doctors and other practitioners about the epidemiology of diseases, the use of drugs and devices among diverse patient populations, and the unmet medical needs of patients. On the flip side, physicians and other healthcare providers need to keep abreast of new drug and medtech developments, and to meet with their peers to learn and share their experiences and best practice.’

Full transparency

Despite the evident benefits of healthcare industry and providers working together, the financial remuneration of HCPs and HCOs has long been at the root of public unease about potential conflicts of interest. HCPs and HCOs may be paid directly for consultancy, advisory and educational expertise. Physicians or HCOs are sometimes sponsored to attend or even head up conferences, and industry funding allows doctors and consultants to participate in clinical trials or carry out R&D. The question is, do these relationships affect the independence of healthcare professionals? Or, more bluntly, do direct payments represent financial incentives that encourage HCPs to prescribe or purchase their sponsors’ drugs or devices?

To address public concerns, in 2013 the European Federation of Pharmaceutical Industries and Associations (EFPIA) set in motion an auto-regulatory initiative that aims to ensure both the integrity and complete transparency of any transfer of value or remuneration between companies, HCPs and HCOs. Under the initiative each pharmaceutical company active in Europe was required, by June 30 2016, to publicly disclose all payments to HCPs and HCOs, dating back to January 2015. The ultimate goal, as EFPIA says in its code on the disclosure of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organisations, is to ensure that ‘these interactions meet the high standards of integrity that patients, governments and other stakeholders expect,’ and to ‘enable public scrutiny and understanding of these relationships and thus contribute to the confidence of stakeholders.’

Individual countries have been given free rein on how to make these disclosures, De Gauquier continues. ‘In some countries each company simply makes the information public on its own website. In other countries public platforms have been established by governments or by industry organisations. Belgium and the Netherlands are unusual in that they have established multi-stakeholder platforms on which both the industry associations and the healthcare professional organisations are represented.’

The Belgian platform, betransparent, was launched on 22 June 2016 as a public website. Four industry associations are represented, and by 2018 some 400 companies affiliated to these associations must publish every transfer of value or payment made in favour of an HCP or HCO, annually. The four associations are:

  • be: Association Générale de l’Industrie du Médicament, which includes 130 Belgian innovative pharmaceutical companies;
  • beMedTech: Fédération Belge de l’Industrie des Technologies Médicales, which is the umbrella organisation for 220 medtech companies;
  • FeBelGen: Association Belge de l’Industrie des Médicaments Génériques et Biosimilaires, which includes a dozen generics firms;
  • BACHI: Association Belge de l’Industrie de Médicaments en vente libre et des produits de santé vendus en pharmacie, to which some 30 OTC and healthcare product companies are affiliated.

Also represented on the betransparent website are 23 umbrella associations for the country’s physicians, pharmacists, veterinarians, dentists, nurses, paramedics, physiotherapists, hospital technicians and wholesaler-distributors. Although not compulsory for the medtech or OTC sectors, the 220 companies that are affiliated to Belgium’s medtech industry association, as well as the country’s OTC association companies, have also joined the betransparent registry.

An end to kickbacks

Kristel de Gauquier

Kristel de Gauquier

‘There is as yet no legal requirement in Belgium to publish details about payments to HCOs and HCPs, so affiliation with betransparent effectively cements the commitment of both the healthcare industry and its providers and practitioners to maintain ethically sound financial relationships,’ De Gauquier suggests. ‘In fact, Belgium is no stranger to auto-regulation initiatives that aim to validate this financial integrity. Already in the country, companies that are looking to sponsor an HCP to attend a medtech or pharmaceutical conference abroad must apply for that individual’s preliminary visa through another auto-regulatory ethical platform, Mdeon.’ Established ten years ago, the health platform Mdeon effectively reviews each visa application to verify that the sponsorship is both legal and ethical. ‘The same HCP and industry associations that have affiliated to Mdeon engaged themselves in betransparent.’

The searchable betransparent database is now live, but as yet only pharmaceutical companies affiliated with Pharma.be have published their transfer of value data for 2015. ‘The medtech and generics companies are still collecting data and will publish in June 2017. Publication by OTC companies will follow in a subsequent phase of developing the platform. It’s been a huge undertaking for all these organisations to tease out the required information, and in some cases has necessitated changes in accounting procedures. Belgium’s privacy laws also mean that the companies have to contact the individual HCPs with whom they have had financial interaction, to ask for their consent to publish. This is also very time consuming.’

The betransparent platform in its current guise represents what De Gauquier suggests is just a foundation for the future. ‘The pharma industries have engaged with the Belgian Minister for Health to establish a pact through which objectives for the next four years have already been laid down. One of these objectives is to set in place legislation that will elaborate on the auto-regulation initiative. Such legislation might, for example, increase the breadth and depth of data that must be disclosed, and possibly encompass other sectors, such as the veterinary industry.’

Access to key figures

So just how much did Belgium’s innovative pharmaceutical industry pay out to HCPs and HCOs in 2015? ‘The sum of all the transfers of value amounted to €138 million,’ De Gauquier states. ‘65 per cent of that total represented direct funding for R&D, and another 13 per cent was given as donations and grants for scientific purposes. Only 5 per cent was paid out for consultancy services, and 17 per cent related to sponsored participation in congresses.’

This puts into perspective the wild misconception that the industry commonly pays physicians to jet off to exotic locations in return for favouring particular drugs or technologies, she continues. ‘It just doesn’t happen. What is important is to provide opportunities for physicians to share their collective knowledge and experience for the purpose of expediting the development of new devices, technologies and medicines and thus improve the quality of care for the patient. This is the message that we feel is really important to get out there, and which we hope that initiatives like betransparent, and future legislation, will help to cement.’

Although initiatives such as this provide the public with information to which it should have access, this financial transparency will undoubtedly also raise concerns, De Gauquier concludes. ‘Therefore, it is imperative to seize the opportunity to explain why these collaborations between the industry and healthcare practitioners are taking place and the value that they ultimately bring to patients. This openness will create even more trust among all the stakeholders that work together to provide patients with the best care.’

About the author

Sophia Ktori writes about pharmaceutical, biotechnology, life sciences, healthcare and medtech for academic and scientific publications.

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