French industry bemoans loss of presence on regulatory bodies
This article was originally published in Scrip
France's drug regulatory agency, Afssaps, has published details of the new membership of its various bodies and committees, including those responsible for drug approvals and pharmacovigilance. The move is noteworthy because the pharmaceutical industry no longer has representation on any of these committees - or indeed on the agency's board.
The changes are part of the government's drive to put more distance between the industry and Afssaps, a requirement of the regulatory reform law that was passed at the end of 2011 to right the wrongs that led to the Mediator affair.
The agency has already announced the start of a new policy under which companies have to pay their regulatory fees and taxes to the state, rather than directly to Afssaps, which will henceforth be funded by a state subsidy (scripintelligence.com, 6 January).
And as a symbol of the government's determination to overhaul the regulatory system following the Mediator scandal, Afsaaps is to change its name to ANSM – the national agency for the safety of medicines and healthcare products. The name change will officially take effect in March, an agency spokesperson confirmed.
Most of the law's provisions have been welcomed by industry, such as stronger pharmacovigilance measures, more transparency and the declaration of industry links with stakeholders.
However, there are some measures it is less happy with - the removal of industry representation within the agency being a case in point, says Christian Lajoux, president of Leem, the association representing pharmaceutical companies in France.
He points out that "before, we were represented on various committees at Afssaps, but now we have lost our seats, even though our contribution to the agency is going up by €40 million. We have lost our seat on the agency's board, even though the board does not make any decisions regarding individual medicines."
Clarity needed on promotional measures
Also irking industry are the new strictures on promotional activities, particularly the requirement for company reps visiting hospitals to see doctors in groups rather than individually, and the mandatory pre-vetting by the agency of all promotional material. Industry needs more clarity on how the promotional measures will work in practice, Mr Lajoux told Scrip in an interview.
There are a number of other grey areas too, including the way that companies should declare their links with doctors, patient groups, the media and so on; how the healthcare assessment body HAS will carry out its strengthened role in medico-economic evaluations; and the circumstances under which comparative clinical trials will be required for drug approval and reimbursement purposes.
On this last point, Leem says that the authorities need to "take account of European evaluation procedures, with which French procedures must remain compatible". This is a reference to the fact that EU legislation does not provide for mandatory comparative clinical trials for drug approval. Afssaps can now request such trials for approval purposes, and any company refusing to conduct them must explain why.
Mr Lajoux says that over the next few weeks, Leem will be meeting officials from Afssaps and the health directorate (DGS), as well as the presidents of the HAS and the pricing committee CEPS, to seek clarification on the grey areas.
CSIS conference a chance for debate
These issues and others affecting the industry will also be discussed in depth at the forthcoming Strategic Council for the Healthcare Industries (CSIS), a high-level biennial industrial policy event that this year is taking place on 25 January.
The CSIS will explore a number of main themes, such as strengthening research partnerships between industry and public bodies, the need to maintain French manufacturing capacity in the face of globalisation, and planning for the future of healthcare, with a focus on innovation and personalised medicine.
The ministers for health, finance, industry and research will be present at the event, so it could be an opportunity for the industry to discuss a more collaborative approach to drug regulation and start turning its back on an unfortunate year that began with the Mediator scandal and ended with the row over the PIP breast implants.
Financial effects
The regulatory reform is one of two major bills approved by the French parliament last year and directly affecting the pharmaceutical industry, the other being the social security financing bill for 2012. This included an increase in the taxes and levies paid by industry, together with substantial drug price cuts and reimbursement delistings.
On 1 December last year, Afssaps removed from the reimbursement list 28 products judged to be of insufficient medical value. Among them was Sanofi Aventis' cardiovascular drug Multaq (dronedarone), whose use the European Medicines Agency has said should be restricted on safety grounds (scripintelligence.com, 23 September).
It is too early to gauge the effects of the government's financial measures on the industry in terms of investments, job losses and the like, as much will depend on how far individual companies are hit by price reductions, reimbursement cuts and taxes, Mr Lajoux says. He expects to have a better idea of the concrete impact by mid-year.
Research projects
Meanwhile, Afssaps has launched its first call for research projects under another provision of the regulatory reform law that allows it to take steps to "encourage research". The aim of the call is to mobilise academic research into the safety of health products (medicines and medical devices) to allow a better benefit-risk evaluation and to strengthen the product surveillance system through research projects that are wholly independent of industry, Afssaps says.
The projects will include five thematic strands: better drug safety monitoring, analyses of the off-label use of medicines, quality controls, benefit-risk profiles in specific populations, and the "behaviour and exposure of French populations to health products". Total funding available for these projects is €6 million this year and more than €8 million in subsequent years.