Academic journal article Applied Health Economics and Health Policy

Ongoing Pharmaceutical Reforms in France: Implications for Key Stakeholder Groups

Academic journal article Applied Health Economics and Health Policy

Ongoing Pharmaceutical Reforms in France: Implications for Key Stakeholder Groups

Article excerpt

Pharmaceutical expenditure has risen rapidly in France, as in other European countries,[1] more than doubling from 1990 to the early 2000s.[2] As a result, ambulatory care pharmaceutical expenditure (14.6% of total healthcare expenditure in 2006) is now higher than physician costs (12.6%) and other community costs in France such as paramedical care (e.g. nurse, physiotherapist, etc.), transport and tests (11.9%).[3] As a result of this increase, France has one of the highest pharmaceutical expenditures per capita in Europe[4,5] at $US554 in 2005 compared with $US517 for Spain, $US509 for Italy, $US498 for Germany and $US351 for Sweden,[6] as well as one of the highest drug consumptions by prescribed volume.[5] However, this must be balanced against high patient satisfaction levels,[5] including satisfaction with the National Social Health Insurance system (L'Assurance Maladie),[7] resulting in France being ranked number one for healthcare by the WHO in 2000.[5,8,9] In addition, France has historically had high survival rates for patients with cancer compared with other European and North American countries,[10] although in recent times has dropped down the league table in this respect.[11]

This increase in pharmaceutical expenditure in France has been driven by increased volumes, reflecting greater prevalence of chronic diseases such as cardiovascular disease, diabetes mellitus, AIDS/HIV and cancer, as well as the prescription of new expensive medicines enhanced by a tradition of considerable prescribing freedom among physicians and choice of physician among patients in France.[8,12-15] This has led to the instigation of a range of supply- and demand-side measures in recent years in an attempt to moderate growth in expenditure.

The aim of this article is to provide a comprehensive compilation of recent and ongoing pharmaceutical reforms and initiatives in France and, where such information has been published, their impact. It is possible that some of these reforms may provide useful examples for other European countries. In addition, this article, which also discusses future reforms, may provide information and guidance to pharmaceutical companies seeking to refine their future activities.

1. Pharmaceutical Reforms and their Impact

The pharmaceutical reforms and initiatives have been subdivided into those impacting on prices (supply-side reforms) and those impacting on the quality and quantity of prescribing (demand-side reforms).

1.1 Supply-Side Reforms and Initiatives

1.1.1 Formal Processes to Assess the Value of New Products in Ambulatory Care and Accelerate Access to New Innovative Drugs

The French National Authority for Health (La Haute Autorité de Santé; HAS), on the advice of the Transparency Commission (Commission de la Transparence), is responsible for determining whether new ambulatory care drugs should be reimbursed on the basis of the absolute level of medical benefit provided (Medical Service Rendering [Service Médical Rendu; SMR]).[16-18]

Five criteria are typically used by the Transparency Commission to assess the SMR rating of new and existing products:[12,18-21]

* effectiveness of the drug and its potential adverse effect profile;

* place of the drug in the therapeutic process in relation to alternatives currently available in France;

* seriousness of the pathology/disease in question;

* curative, preventative or symptomatic relief properties of the drug; and

* impact of the drug on public health.

Subsequent reimbursement varies between 0% for 'no or inadequate therapeutic value' with insufficient justification for reimbursement, 35% for 'moderate or low/weak' level of innovation or major innovation in a non-serious pathology, and 65% reimbursement for 'major or considerable' innovation in a serious pathology disease.[12,16,19,21,22]

In practice, based on an evaluation of 1453 drugs in five therapeutic areas, only two criteria typically determine SMR values for new ambulatory care drugs. …

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