French unveil plan to save €350m through greater use of generics
This article was originally published in Scrip
The French government has unveiled plans to boost the prescribing and dispensing of generic medicines, with a view to making an additional €350m in savings over the next three years. Most of the measures are aimed at healthcare professionals and the public, although the authorities have called on pharmaceutical firms to help by printing the INN more prominently on product packs.
Presenting the plan to healthcare personnel, patient bodies, hospital groups, unions, medical colleges and professional and educational bodies, the government said that the objective was to encourage the use of generics in the community, in hospitals and in care homes for the elderly, "while respecting freedom of prescribing".
Key stakeholders, including the medical profession, are being asked to sign up to the plan in an effort to "remove the last remaining brakes on the use of generic medicines in all situations where this is possible", the government said. "A national communication campaign aimed at the public and health professionals will be launched at the end of 2015 to strengthen trust in generics, which are effective, high-quality medicines".
The fact that government efforts are needed to instil trust in the efficacy and quality of generics says something about how these products are regarded in France, where many doctors still ignore exhortations to prescribe generically and tend to make more use than they should of their ability to write "no substitution" on the prescription form. Given that these behaviours are among those targeted in the new plan, it's no surprise that several doctors' unions have said they will not sign up to the plan in its present form.
The French generic industry body GEMME, though, welcomed the plan, saying that it showed a "strong commitment" by the authorities and stakeholders to boosting the generics market, which is lagging behind those of comparable countries. GEMME president Pascal Brière said the plan "takes account of all the essential factors: it is clearly a result of an exhaustive and coherent analysis of the obstacles encountered by generic medicines".
Measures
A key aim of the plan, which is being overseen by the social affairs inspectorate (IGAS), is to boost the prescribing of generics by five percentage points over the 2015-2017 period. At present, generics account for 40% of prescribing in volume terms and for 28% by value (the figures relate to prescribing within the list of generic groups containing both patent-expired brands and their generic versions).
Among the measures are increasing use of generics in hospitals and in patients moving from hospital to community care, and the use of special prescriptions with a choice of rolling menus that give preference to prescribing from the generics list.
The plan reminds doctors of their obligation to prescribe all medicines by the INN as of 1 January this year, discourages them from over-using their ability to write "no substitution" on the prescription form, and encourages pharmacists to engage in "responsible" generic substitution. IT prescribing aids are to be used more widely.
The government says it also wants the regulatory agency, ANSM, to draw up a recommendation that companies print the INN more prominently on packs of all medicines, "in order to establish a clearer and more understandable link between the prescription and the medicines actually prescribed". This should also be pursued at EU level, it says.
In order to develop trust in generics, it is intended to establish a single source of information for patients and health professionals (at medicaments.gouv.fr) and to run an information campaign on prescribing of generics stressing that generics are as strictly regulated as branded drugs, that there are no specific pharmacovigilance issues with generics, and that the oldest generics are the most well known because their time on the market has allowed all their possible side-effects to be detected.
As a way of ensuring the earliest generic penetration, tools will be put in place to alert the authorities to forthcoming patent expiries and the time taken to approve new generics will be "optimized".
The government also wants the HTA body (HAS) to review its recommendations on treatment strategies after products come off patent, and plans to publish decisions condemning "efforts to denigrate or avoid the use of generics". Doctors' initial training on medicines in general and on generics in particular will be strengthened.
Reactions
GEMME said it was particularly important that the plan relied on the collaboration of doctors and pharmacists, and that it included measures to improve training for health professionals and strengthen communications to the public in order to increase confidence in generics. It said it would also be important to extend the system of remunerating health professionals on the basis of public health objectives by increasing prescribing within the generics list and ensuring patients leaving hospital continued their treatment in the community with generic medicines.
But several bodies representing doctors have taken issue with the plan and have said they will not sign up to it, according to the doctors' daily newspaper, Le Quotidien du Médecin. It quoted the president of one of the main medical unions, the CSMF, as saying that the plan gives the national health insurers "carte blanche" to punish doctors who write "no substitution" on the prescription form. Another union, the FMF, said it might be willing to go along with the plan as long as this measure was dropped.
Doctors' bodies were also agreed, the newspaper said, that they had more pressing matters to think about: ie the health reform bill that is going through parliament and will introduce a number of changes in areas such as drug shortages, clinical trials, and information to doctors to help them in their drug prescribing (scripintelligence.com, 9 February).
The doctors are particularly incensed at a proposal in the bill to extend the third-party payment system to their medical fees: if this happened, doctors would have to claim back the fee from the relevant health insurer rather than being paid directly by the patient.