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160 Health systems in transition France To shed further light on the ties between health professionals and the pharmaceutical industry, drug companies are required to disclose the agreements and other benefits provided to a wide range of individuals and organizations participating in the health system. In 2014, the government initiated a new web site that identifies health professionals’ ties to businesses that market health products or cosmetics (www.transparence.sante.gouv.fr). In addition, limits have been placed on visits by pharmaceutical representatives in hospitals, and advertisements aimed at health professionals are subject to prior approval by ANSM. The Health Security Law also includes new pharmacovigilance requirements designed to strengthen the surveillance of drugs on the market. Manufacturers must register, declare and monitor adverse side-effects, which may also have implications for post-authorization studies of safety and efficacy. Actions taken in other countries with respect to drugs authorized in France must also be reported. Any suspension, withdrawal or notification regarding a drug must be made public immediately at the expense of the manufacturer. Certain health professionals (physicians, dental surgeons, midwives and pharmacists) are also required to report adverse side-effects. A whistle-blower provision protects from discriminatory employment actions all those who report adverse effects in good faith. Doctors prescribing a medication outside of its authorized indications must explain orally the reasons to the patient, as well as noting it within the medical file and on the prescription. Given the context of the Mediator scandal and the need to restore public confidence in the system of drug regulation in France, passage of this Law was relatively consensual among the stakeholders, including the pharmaceutical industry. 6.1.2 Containing SHI expenditure while striving for equity in financial access The organizational structure of the French health care system makes the goal of cost-containment difficult to achieve. Indeed, controlling expenditure is a complicated task when consumption by patients and provision of care by providers are unrestricted, where care is largely publicly funded and retrospectively reimbursed, and where local SHI funds reimburse care without information regarding its appropriateness and efficiency. Certain expenditure categories, particularly drugs, have been the target of numerous cost-containment measures.
Health systems in transition France 161 Cost containment measures fall into two broad categories: strict accounting cost-containment policies (maitrise comptable des dépenses de santé), which have been implemented since the late 1970s and focus on controlling provider tariffs and the volume of care provided and on decreasing SHI expenditure, and medically based cost-containment policies (maîtrise médicalisée des dépenses de santé), which were developed later in the 1990s and aimed to reduce the financial and equity losses linked to medical practice variations while improving medical practice. The strict accounting cost-containment policies were strongly opposed by physicians (see section 3.5 in Chevreul et al., 2010). However, both types of policy continue to be used in France. The following subsections highlight measures taken since 2010 (for additional details and earlier cost-containment reforms, see section 7.1.3 in Chevreul et al., 2010), as well as measures to mitigate the impact of shifting costs from SHI to private expenditure. Strict accounting cost-containment measures Decreasing the benefit package Decreasing the benefit package is one means of decreasing the financial burden on SHI. Of all health care goods and services, drugs were the most affected by this type of measure. Between 1990 and 2009, prescription drug sales in France multiplied 2.5 times, with SHI covering approximately 75% of the total (Cour des comptes, 2011b). The steady increase in pharmaceutical expenditure has led to a series of measures aimed at limiting the usage of certain drugs and/or reducing the cost for SHI. Cost-containment measures have included increasing patient contributions (often covered by VHI), either by de-listing the drugs completely or reducing the rate of SHI coverage, reducing drug prices and encouraging generic substitution. Economic evaluation is the newest tool in the cost-containment policies. De-listing drugs has proven to be politically sensitive, as revealed by the history of de-listing since the late 1990s. In certain cases, drugs with insufficient SMR were subject to lower prices or reimbursement rates or even left at a 65% rate rather than being de-listed. A provisional coverage rate of 15% was instituted for certain drugs as an interim step towards de-listing in 2008. In 2010, the coverage rate for drugs with weak relative SMR decreased from 35% to 15%, and in 2011, the rate for drugs with moderate SMR was reduced from 35% to 30%. An additional 26 drugs were de-listed in 2011, including 17 that had been covered at 15%. The Minister in charge of Health announced in January 2011 that all drugs with an insufficient SMR would be de-listed or subject to a systematically motivated decision if coverage was to
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Contents Contents Preface
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Preface Preface The Health Systems
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Abstract Abstract This analysis of
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3. Financing 3. Financing Health ca
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