Context: transparency situation in Europe

Marketing to doctors

Pharma and medical technology companies spend a LOT of money to promote their products to doctors and other healthcare providers. This marketing takes the form of gifts, meals, invitations to conferences, highly paid scientific advice, research grants, sponsorships, etc.

Although slightly outdated and US-centered, here is a great – and funny – introduction to this topic, from John Oliver in “Last week tonight”

This marketing is highly effective. It often distorts medical knowledge and practice and increases product sales [1]Stamatakis E , Weiler R , Ioannidis JP. Undue industry influences that distort healthcare research, strategy, expenditure and practice: a review. Eur J Clin Invest 2013;43:469–75. … Continue reading. It also places a heavy and increasing burden on health care costs. And while it benefits doctors financially and otherwise (e.g. greater career opportunities), it can put patients at unnecessary risk.

Several health scandals have repeatedly brought these problematic marketing practices into sharp focus, and called for more stringent regulation.

Transparency regulation in Europe

In the early 2010s, several European countries introduced so-called “Sunshine Acts”, which require industry to disclose publicly all financial links with health care providers. This movement started in the US, followed in Europe by France, Portugal, Greece, Romania, Latvia and Denmark[2]https://haiweb.org/wp-content/uploads/2017/03/Sunshine-Act.pdf.

Faced with such legislative developments in European countries, the pharmaceutical industries launched their own Disclosure Code in 2013, in the form of a voluntary Code of conduct.[3]https://www.efpia.eu/relationships-code/the-efpia-code/

The EFPIA Transparency initiative

EFPIA (European Federation of Pharmaceutical Industries and Association) is a trade group representing the pharma industry in Europe. Its members are pharma companies, and the national pharma trade group in each country. 

EFPIA launched its transparency initiative in 2013 and was subsequently implemented by trade associations in individual countries. In theory, each company commits to following a Code of conduct, and to disclose their payments to doctors, and other healthcare professionals such as nurses, professional and scientific organisations, and patient organisations. 

Despite its promises, this voluntary initiative has several main shortcomings:

  • Scattered data, unusable in practice
    Only two countries (Ireland and the UK) chose to implement a single website that allows payments from all companies to be searched by recipient or drug company name. Elsewhere, the data is available only as PDF files on each company’s website. Looking for the payments received by one professional requires anyone to go through hundreds of documents on multiple websites. The data is disclosed, but in a way that makes it unusable.
  • Asking for doctor’s consent
    In most countries, doctors or even healthcare organisations, such as hospitals, can refuse to have their names published in the disclosure to protect their private life. In this case, the information is presented aggregated, without recipient name. In Germany, 80% of the amount spent on doctors is disclosed without the doctor’s name. Transparenz? Nein, danke.
  • R&D: one category to hide them all
    R&D expenses are disclosed only as a total amount per company and per year, with no information on recipients or what exactly was funded. The definition of what can come in this category is too broad, with the result that XXX % of the total sum is disclosed as R&D expense, with no details whatsoever. 
  • No recipient unique IDs
    Recipients don’t have to be identified by an unique ID, making it impossible to link the payment data with other relevant sources (for example prescription data, which would allow to see if payments result in increased prescribing of specific drugs), or to be sure that each recipient is identified correctly, without any ambiguities.
  • No consequences
    Perhaps the biggest shortcoming lies in its very nature. It is a voluntary disclosure initiative, not a law. Drug companies could still hide things without actually risking anything, while claiming they are behaving in a transparent way. EFPIA can in theory sanction them for not following their code of conduct, but no one can seriously consider this as a real threat given the lack of serious sanctions.

These shortcomings are not accidental mistakes, but deliberate choices. They reveal the true nature of the EFPIA initiative: a damage control operation, disclosing some data in the least industry-harmful way, so that the need for real transparency laws is less obvious. 

This is summarized by a quote from the EFPIA itself, in their 2018 code report:

EFPIA strongly believes that transparency is best achieved without legislation.[4]https://www.efpia.eu/media/554642/efpia-code-report-2018.pdf, page 8

References

References
1 Stamatakis E , Weiler R , Ioannidis JP. Undue industry influences that distort healthcare research, strategy, expenditure and practice: a review. Eur J Clin Invest 2013;43:469–75. doi:10.1111/eci.12074
2 https://haiweb.org/wp-content/uploads/2017/03/Sunshine-Act.pdf
3 https://www.efpia.eu/relationships-code/the-efpia-code/
4 https://www.efpia.eu/media/554642/efpia-code-report-2018.pdf, page 8