Context: transparency situation in Europe

Marketing to doctors

Pharma and medtech companies spend a LOT of money to promote their products to doctors [TODO XXX references XXX]. This marketing takes the form of attractive medical visitors, 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Although slightly outdated and US-centered, here is a great – and funny – introduction to this topic, from John Oliver in “Last week tonight”

Health scandals to legislations

This systematic marketing is highly effective. It distort medical practice, and even medical knowledge, to increase industry sales. [TODO XXX references XXX]. As a consequence, it places a heavy and increasing burden on health care costs. And while it benefit to doctors, it can put patients at unnecessary risk.

Several health scandals have recently brought these problematic marketing practices into sharp focus. Vioxx XXX, Mediator XXX, XXX qui a été interdit de faire des congrès =>

Different legislations in Europe

Instead of forbidding such marketing, legislations have tended to impose transparency, with the hope that transparency will lead to self control from companies and doctors, slowly eliminating shady practices. After a few years, we can see little effects of the transparency laws (XX REFERENCES), except to diagnose the extent of the problem and prevent certain conflicts of interests.

The EFPIA Transparency initiative

The EFPIA is the trade group representing the pharma industry in Europe. Its members are pharma companies, and the national pharma trade groups of each country. 

Following the Sunshine Acts in the US in 2010 and in France in 2011, the EFPIA launched their own transparency initiative in 2013, that was then implemented by each european countries’ trade associations. In theory, each company commits to following a code of conduct, and to disclose their financial ties to doctors, associations of doctors, and patient organisations. 

We see several shortcomings of this voluntary initiative from the Pharma industry. Some of them are at definition level: 

  • Too small scope
    things like meals and gifts don’t have to be disclosed, although research show that these also have a great influence on doctors: there is no small gift (PUT REF)
  • R&D: one category to hide them all
    R&D expenses are disclosed only at company level each year, with no info on recipients. 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. 
  • Loose definitions
    Category definitions are so loose that companies publish “methodological notes”, to explain their interpretation of the code. The point of the code should be to create a standard. Almost laughably, each company chooses whether they include taxes in their disclosure documents, making comparison between companies impossible or imprecise.
  • No recipient unique IDs
    Recipients don’t have to be identified by an external ID, making it impossible to cross the data with other sources (for example prescription data).
  • Asking for doctor’s consent
    In most countries, doctors 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.
  • 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. The EFPIA can in theory sanction them for not following their code of conduct, but no one can seriously consider this as a real threat for the pharma companies. 

Beside these, we have to look in practice on how the data is disclosed. A lot of room was left to the national trade associations to implement the EFPIA code. This leads to different country situations. On XX countries: 

  1. 2 countries have a centralised database (Ireland and UK), with a unique website that is searchable. In the UK, the data is even directly downloadable! 
  2. X countries have a webpage listing all disclosure documents of the companies, usually PDFs
  3. X countries have the disclosure documents only on the website of each pharma company. 

In the vast majority of countries (B + C), looking for the ties of a particular doctor would mean going through hundreds of pdfs scattered among dozens of websites. The data is disclosed, but in a way that makes it unusable. 

These shortcomings are not mistakes, but 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 sumarized by a quote from the EFPIA itself, in their 2018 code report:

EFPIA strongly believes that transparency is best achieved without legislation.

https://www.efpia.eu/media/554642/efpia-code-report-2018.pdf, page 8

If we let the pharma industry define what transparency is, you get something that looks transparent, yet which is not remotely actionable.