Plan to force drug companies in France to reveal payments to doctors has been diluted, campaigners sayBMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8405 (Published 12 December 2012) Cite this as: BMJ 2012;345:e8405
A new draft of the French government’s “sunshine act,” designed to show how much drug companies pay doctors, has watered down the original proposals, critics say.
They object to the fact that drug companies would not have to declare any payments done for work undertaken, only for unconditional gifts; that they would not have to publicise the payments on their own websites; that they would not have to declare any payments under €60 (£75; $95); and that they would have to ensure that doctors’ names were not indexed, to prevent search engines discovering whether a doctor had received payments from several companies.
The groups objecting to the changes made by the Socialist government span the political spectrum. They also include the independent pharmaceutical journal Prescrire and the medical association Formindep, which has been campaigning for all continuing medical education to be made independent of the drugs industry. At the more conservative end of the spectrum is the Conseil National de l’Ordre des Médecins (CNOM), the regulator of the medical profession.
In December 2011 the French parliament adopted a bill setting strict rules on drug regulation, in the wake of the scandal over the drug benfluorex. Its manufacturer, Servier, took several years to withdraw the drug despite evidence of harm and long after it was banned in other countries.1 2
The new bill was supposed to prevent conflicts of interests and, in a reference to the US Sunshine Acts, to shed light on the financial links between the drug industry and doctors.
After François Hollande’s election as president in May 2012, and with a new majority for the Socialists in parliament, the responsibility of producing a draft law to implement the new rules on transparency fell to the new minister of social affairs and health, Marisol Touraine.
The health ministry organised several meetings with representatives of the health professions, medical regulators, drug companies, Prescrire, and medical press groups to discuss the drafts of a decree and of a ministerial circular it had prepared.
Disagreement arose between two camps. Non-governmental organisations affiliated to the Medicines in Europe Forum and the French medical regulator (CNOM) objected to the bill’s changes, while the health ministry and drug industry representatives were largely supportive.
The Medicines in Europe Forum issued an angry press release in November, saying, “Civil society cannot accept that the government should base its health strategy solely on industry interests.”
Earlier, in a press release in October, CNOM had summarised its criticisms under the headline “Publication of links of interest: from light to obscurity.”
Four points of disagreement came to light. The act specifies that two categories of reward should be considered under the law. It makes a distinction between unconditional gifts given to doctors and agreements between doctors and drug companies for work carried out by the doctors. Although drug companies and doctors would have to declare the existence of any financial agreement between them, they would not have to publish the content of any such agreement. The law bans outright gifts rather than payment for work, meaning that any compensation for work carried out, regardless of the amount, would not have to be made public. The nature of the work would not have to be made public, and if the money was paid through an association subsidised by a drug company that would also remain confidential.
The second point of contention involves how details of any gifts would be published. The draft act said that publication must take place on each company’s website and that the information must be open access. An amendment has been added, however, stating, “Ultimately, publication may take place on a single public website.” Furthermore, the draft emphasises that the company in charge of the website is supposed “to ensure that measures are put in place to prevent search engines from indexing beneficiaries.”
Such measures would make it impossible for members of the public to discover whether an individual had received gifts from different sources. A member of the health ministry told the BMJ that this clause was necessitated by the requirements of the Commission Nationale de l’Informatique et des Libertés (the independent French administrative authority created to ensure implementation of the law on data privacy).
The third point concerns the level at which reporting of payments and gifts must start. Although the health minister, Xavier Bertrand, has said that all payments, from €1 up, would have to be declared, the draft sets the threshold at €60.
The ministerial circular explains that “the intention of the legislator wasn’t to impose on companies the reporting of benefits which are perceived as being too negligible to affect the independence of the individuals to whom they are given.” CNOM, Formindep, and Prescrire have all protested about this, but to no effect.
Finally, the fourth point of disagreement is over the idea that drug companies do not have to specify exactly what they have paid to a doctor in a six month period but merely the financial category into which the payments fall. The draft bill specifies six increasing categories of payments that a drug company has to indicate, the first being €60 to €500, and the fourth being €10 000 to €100 000. Unlike the health ministry and other participants in the discussions, CNOM and Formindep have demanded that specific amounts be given instead of just categories.
Opponents of the changes point out that if the new draft version becomes the final law, the new Socialist government would be passing a law that was more favourable to the drug industry than that proposed by the previous conservative government.
Cite this as: BMJ 2012;345:e8405