These directives are intended to ensure, in particular, the respect of the government’s goals for national health insurance expenditures (Article L. 162-17-3 of the Social Security Code). In this list, products are designated with their own brand name. A franchise of €0.50 is levied on reimbursable drugs by the health insurance. Various policies aimed at encouraging both doctors and pharmacies to favour the use of generics. In Europe, a CE mark ensures that medical devices meet the European Directives requirements. Reimbursement of e ective drugs is generous, however there are large patient copayments (often … +1 (0) 617.275.4465. The request is reviewed by the HAS’ Commission on Transparency, which assesses the medical service provided (e.g. However, there are regular delays in these procedures. On April 26, 2016, the Competition Authority issued an opinion on the online sales of medicine. According to the Quotidien du Pharmacien trade magazine, France has 20 million patients with chronic conditions. Drug treatments can be initiated in hospitals and continued for outpatients through a prescription issued by … In general, a patient purchases the drugs and is later refunded. aims to improve patient care and provide more consistency within the healthcare system. A cost/effectiveness analysis may be submitted, in both dossiers. The availability of generic drugs most often reduces the price of a drug for two reasons: The price of the generic drug is also automatically decreased 18 months after its marketing launch, by 7%. In just over a decade, the world will probably have about 8.5 billion people, and nearly 10 billion by 2050, compared to 7.7 billion currently according to the United Nations Population Division (World Population Prospects, 2019 Revision). Only in extreme circumstances where a person suffers from irreversible brain damage or other severe injuries will health experts consider requests by family members to remove life support, or advise a family that such a move is advisable. 5 Book of the German Social Code would require all pharmacies to comply with the general price regime set forth in the German Ordinance on Drug Prices (i.e. In the event of a request for a hearing, the committee must hold it within a maximum period of 45 days following receipt of the company’s request. Drugs sold by pharmacies or by hospitals: the sale price to the public is set by convention between the pharmaceutical company and the CEPS. Since 2003, the price of innovative specialities has been subject to a certain degree of freedom since the laboratory proposes it and it is then approved by the CEPS. The Authority held that dysfunctions in full competition can influence the development of the market, and thereby keep some drug prices higher than they might be. Social Security gap in light of the COVID-19 sanitary crisis. This organization is an independent public body with financial autonomy – and report its activities to the Government. more specialised treatments, including those reserved for hospital use or that can be prescribed only by a hospital, or that need a specific doctor’s prescription, or require more detailed monitoring during their use. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? If the medical procedure doesn’t need to be coded for reimbursement, the French National Authority for Health (HAS) only needs to submit an assessment report and conclusions on the safety and efficacy of the new device. France’s national federation of medical insurance funds (Union Nationale des Caisses d’Assurance Maladie) is composed of representatives of the general system and the agricultural system. These are either drugs for which the manufacturer has not claimed reimbursement from health insurance (the most common case), or drugs that have not been included on the list of products that can be reimbursed in a particular town or hospital. If the medical device is only used within a medical procedure that is not coded for reimbursement, the new procedure must be enlisted to obtain reimbursement in an ambulatory or hospital setting. The overall growth rate of drugs expenditure is based on three effects: The average price of drugs, in pharmacies: Average pre-tax manufacturer price of one box (€), Average public price, including tax of one box (€). The technical dossier includes technical description of the technology and its use, the severity of the condition, clinical benefits and alternatives. In 2016, employees paid around 8% of salary while employers paid around 13%. In response to an overall increase in drug prices, a group of associations called on the French government to commit itself to the “transparency” resolution presented to the WHO General Assembly on Health on May 20–28, 2019, in Geneva, Switzerland. Similarily the free distribution of face masks has been limited to people in possession of a medical prescription certifying they are in “fragile” health or “vulnerable” to the virus. +41 (0) 61 535 1109, IDR Medical UK The presence of generic and biosimilar drugs on the market. A particular focus will be on the reimbursement system in France, as France has a unique early access program for life-saving drugs and is often the first country to enter the European market. How do politics affect pricing and reimbursement policies? The average public price, including tax and the average margin, continues to decline. Important issues discussed in the national media. Similarly, treatments for various cancers are subject to administrative barriers that limit their prescription, because of their high prices. Healthcare coverage has increasingly focused on a shrinking number of doctors and other practitioners in rural areas, reflecting population declines as more households move to larger cities. Producers of goods and services (pharmaceutical industry). These discounts correspond to sums due in application to the clauses provided in the contract between the CEPS and the laboratories. France provides a mandatory social health insurance system (, ) that covers the entire population. hbspt.cta._relativeUrls=true;hbspt.cta.load(2938757, 'c2692277-9bb1-4cce-830b-b893f26d58c5', {"region":"na1"}); The Reimbursement Environment for Medical Devices in France, France’s national healthcare system is managed by the government and the Parliament, while 25 health agencies (. ) According to Article L.5111-1 of the Public Health Code: “A drug is any substance or composition presented as having curative or preventive properties against human or animal diseases, as well as any substance or composition that may be used or administered to humans or animals, with a view to establishing a medical diagnosis or restoring, correcting or modifying their physiological functions by exercising a pharmacological, immunological or metabolic action. The mission of examining drugs is the responsibility of the Transparency Commission integrated into the HAS (Haute Autorité de Santé). People who have signed up for supplementary health insurance policies often have the full cost of their treatments reimbursed, based on the terms of their contract. Coverage and Benefits: French NHI covers services ranging from hospital care, outpatient services, prescription drugs (including homeopathic products), spa treatments, nursing home care, cash benefits, and to a lesser extent, dental and vision care. European Commission, Expert Panel on Effective Ways of Investing in Health, Opinion on Innovative payment models for high-cost innovative medicines, January 17, 2018. Public funding is applied to both private and public sectors, although tariffs differ. The higher the costs of bringing a new and innovative treatment to market, the higher the cost is likely to be for consumers, especially if the number of patients benefiting is relatively small. There are three types of pharmaceutical products: Also, Article L. 5121-1 of the Public Health Code distinguishes drugs according to their preparation, for instance: In order to be eligible for reimbursement by Social Security, drugs must be covered by Chapter 3 of the Security Code. To be covered by Social Security, a drug must be included in the list of pharmaceutical specialities reimbursable to contributors (positive list), published in the Official Journal, which specifies the reimbursable therapeutic indications. The EMEA also distinguishes Falsified Medicines, defined as “fake medicines that are designed to mimic real medicines”, from Counterfeit Medicines, or “medicines that do not comply with intellectual property rights or that infringe trademark law”. drugs that have forms, dosing and presentation not justified by a therapeutic use; drugs that do not improve medical service according to the Commission on Transparency or do not generate savings in the drugs’ treatment; drugs that might generate an increase in consumption or unjustified expenditures; drugs whose prices are not justified; and/or. CNEDiMTS, or National Commission for the Evaluation of Medical Devices and Health Technologies. Five indications have been selected by a Temporary scientific specialty committee  “Comité Scientifique Spécialisé Temporaire” (CSST): neuropathic pain; certain forms of severe epilepsy; supportive cancer care; palliative care; and painful spasticity (contraction) due to multiple sclerosis or other diseases of the central nervous system. 22 Scenario 1: Standard Pathway to change the weight / tariff of a DRG Year 1 The European Commission, after receiving an opinion from the European Medicines Agency (EMA). are responsible for the healthcare system at a regional level. 1. Reimbursement starts immediately after market launch. Based on the approval, the Committee of Grading of Medical Procedures (CHAP: Commission De Hiérarchisation des Actes Professionnels) fixes reimbursement tariffs after negotiating with unions of health professionals. On May 29, 2017, the seventh World Health Assembly of the World Health Organization (WTO) agreed to adopt the new designation of “substandard and falsified” (SF) for medical products considered “substandard/spurious/falsely-labelled/falsified/counterfeit” (SSFFC). Instead, the provisions governing the reimbursement system for the SHI as set forth in No. Social contributions: Charges collected directly based on salary and which must be paid by both employees and employers. Unlike in other European countries, in France it is not Social Security that negotiates drug prices and reimbursement rates, but an inter-ministerial committee, the CEPS, which operates under the joint authority of the Ministry of Health and the Ministry of the Economy. This draft law, whose debate was suspended during the COVID-19 crisis, would have removed this requirement. drugs that do not mention on their packaging, labelling, leaflet or advertisement a therapeutic use. In most cases, Social Security reimburses the bulk of a patient’s outlays. The costs associated with the development of new medicines are increasing (almost €1 billion), according to the Leem organisation, which it says justifies a strong protection of profit margins for innovation. The criteria of improvement of the medical service provided are the added value of the new drug over and above existing treatments, and the efficiency and the tolerance levels for patients. For families with annual incomes below a fixed threshold, the government provides free complementary cover (, he French Health Products Safety Agency is, The reimbursement by the MHI (Mandatory Health Insurance) for a device in ambulatory care or for a device that is too expensive for the DRG tariff is enlisted on a ‘positive list’ (LPRR -, Listing under the medical device own trade name, CNEDiMTS requires the manufacturer to submit 2 dossiers: a. This means the device will be reimbursed by the MHI at the existing tariff. AT A GLANCE France has a centralised pricing and reimbursement system, with a substantial amount of in uence held by the Transparency Commission of the Haute Autorité de Santé, although public and private insurers are also involved in pricing decisions. As mentioned above, in setting the price the CEPS takes into account: the improvement provided by the drug; the results of economic and medical evaluations; the price of drugs with the same therapeutic effect; sales volumes; and the foreseeable and actual conditions of a drug’s use. Individual contributions to a Mutuelle depend on a variety of personal circumstances (age, status of employee or unemployed person, place of residence, income, and the desired level of protection). Drugs sold directly to the health establishment: the price is negotiated directly by health establishments. To decrease the cost of distribution, the French court of audit “La Cour des comptes” recommends regular reviews of remunerations for pharmacies and wholesalers. The Problem Reimbursement for a hospital inpatient stay in the US is determined according to a Medicare Severity Diagnosis Related Group (MS-DRG). Hospital drug prices were completely unregulated until 2003 and were the result of negotiations between laboratories and hospitals. But very often their eligibility arises through the membership of a husband, cohabitant, or parent paying contributions. The content of this website is for general information purposes only and does not purport to provide comprehensive full legal or other advice. After the government implemented the obligation to wear a mask in closed public spaces in July 2020, the Ministry of Health had to guarantee the distribution of free masks to the most vulnerable, to ensure a continuity in the providential nature of the French health system. Similarly, reimbursement for a hospital inpatient stay in France is determined according to a Homogeneous Group of Stay (Groupe Homogène de Séjour, GHS). Their 3 core missions are scientific evaluation, laboratory control and advertising control. With the regime’s definitive disappearance on August 31, 2019, students are now linked to the general social security system, and no longer pay contributions. The first step to ensure that a medical device has market access is to gain certification by a notified body. These procedures are used when the product is intended for several Member States of the European Union. The healthcare system in France is funded partially by obligatory French social security contributions ( sécurité sociale ); these are usually deducted from your salary. Shortcomings of the French reimbursement system. Montpellier Drive, Cheltenham, GL50 1TA There are five levels for determining improvement of the medical service provided: major; important; moderate; low; and insufficient. a drug must be sufficiently beneficial) and the improvement of the medical benefit – that is, the drug must make a major contribution compared with similar products (Article R. 163-5 I 2° of the Social Security Code). Resources which fund the social protection are: Any person can subscribe to complementary coverage plans in addition to Social Security, which may also benefit family members. A medicalised mapping of health expenditures for 2017, presented by the CNAM, reveals that 20 million French people have used care related to the management of a chronic pathology, representing 35% of the 57.6 million beneficiaries of the general scheme. In France, in the case of national procedures or national phases of decentralised or mutual recognition procedures, the timeframes are also defined by the regulations. Minimum price decreases are implemented at the time of the generic product’s launching on the market (20%) and 18 months later (12.5%). Above all, it is a system that works, provides universal cover, and is a system that is strongly defended by virtually everyone in France. simplifying liberal practice and freeing up medical time. Other sources of funding come from the state, different social security systems or other social security bodies. If the Health and Social Security ministers oppose it, they can set a price, within 15 days after the committee’s decision (Article L. 162-16-4 of the Social Security Code). France provides a mandatory social health insurance system (Assurance Maladie Obligatoire – AMO) that covers the entire population. 225 Franklin Street, 26th Floor In France, the ageing of its population has coincided with an increase of diagnoses of certain diseases. The so-called “third-party payment against generics”: Automatic reimbursement at the time of purchase (for example, in pharmacies) is possible only if patients accept generic versions of drugs. This paper describes the actual situation in Belgium with special focus on pharmaceutical products and the potential role of pharmacoeconomics in decision making on price and reimbursement. According to the 2017 edition of the Panorama of Health published by the OECD, France spends US$4,600 per capita on health, 15% above the OECD average of about US$ 4,000. Given the challenges of population ageing in France, constant innovation with sufficient protection of patents is key to ensuring reliable revenue streams that encourage further investments, even while sustaining the steady introduction of generic alternatives. This authorisation can be changed or removed. The average pre-tax manufacturer price has decreased from 2008 to 2014, when it stabilised at €7.15. On February 8, 2018, the French government issued an information notice reiterating that the pharmaceutical industry must implement European Regulation 2016/16, which aims to secure the legal supply of drugs and prevent counterfeit products from being introduced into supply chains. In France, the financing of the medical expense reimbursement system is organised into two main levels: compulsory; and supplementary insurance schemes. It usually happens when the device is innovative/with different specification and are presumed to impact health care expenditure. The national procedure is increasingly being used less and less: it applies only to requests for the marketing of medicinal products limited to the national territory, which represents a limited number of medicinal products. The public authorities also assign annual price decreases to the CEPS. With the global COVID-19 pandemic, the supported efforts to produce an efficient vaccine have also contributed to an increase of research and development costs in the medical field. The reimbursement rate depends on the medical service provided for the drug. It’s financed through employers and employees’ payroll contributions and taxes. Because research companies invest in long and costly scientific programmes, they must be able to rely on such rights to secure an acceptable return on investments. If a medical device conforms with the LPRR generic line description, it doesn’t need to go through a CNEDiMTS evaluation. It must be verified that the actual qualitative and quantitative composition corresponds to that declared by the manufacturer, that the medicinal product is not harmful under normal conditions of use, and that the therapeutic effect announced is not lacking or is sufficiently justified by the applicant. Beyond this amount, the coefficient is equal to 0. For new medicinal products intended to be marketed in more than one country, market access has been community-based in the European Union since January 1, 1998, either through the centralised procedure defined in Regulation No 2309/93/EEC as amended by Regulation No 726/2004/EEC, or through the mutual recognition procedure provided for in Directive 2001/83/EC as amended by Directive 2004/27/EC and, since October 2005, through the decentralised procedure provided for in Directive 2004/27/EC. The scope of reimbursable indications is based on the therapeutic strategy recommended by the Transparency Commission that, in certain cases, may lead to a restriction with regard to the marketing authorisation. The arrival of new drugs on the market that are less expensive and more efficient, for example, could justify a decision to withdraw some drugs from the list. The French health care system is one of universal health care largely financed by government national health insurance.In its 2000 assessment of world health care systems, the World Health Organization found that France provided the "best overall health care" in the world. If you are insured (or a beneficiary of the insured) under the social security system of an EU member state, Iceland, Liechtenstein, Norway, or Switzerland, you may be covered for any medically necessary healthcare you receive while visiting France, regardless of whether you are working, unemployed, a resident or a retiree. It sets the support rate of healthcare as well as the reimbursement rate of drugs. Competition authorities look very carefully at the medicines market and pricing. (0). The national health insurance programmes are characterised by compulsory participation that reflects French goals of solidarity between generations and professions. With the development of new vaccines as well as preventive measures such as distribution of face masks and other personal protection equipment (PPD), the French government like others around the world has had to reconsider its financial strategy for the health system, often in response to fast-breaking developments. Since January 2016, the French universal disease protection programme (formerly known as “CMU”, today “Protection Maladie Universelle”, “PUMa”) simplified procedures so that any person residing in France on a continuous and legal basis is able to benefit from medical fees reimbursement. The prices are the result of negotiations between the laboratory and the CEPS. Mobile professionals and auxiliaries: doctors; pharmacists; midwives; nurses; and physiotherapists. Possibility for pharmacists to dispense certain medicines. These authorisations are granted for a limited period not exceeding one year, though they can be renewed. It also continues to apply for the maintenance of marketing authorisations historically issued at national level. Despite the extensive coverage, care recipients may in some cases remain responsible for paying a portion of treatment expenses. Only recently has France allowed free testing for all, without a medical prescription, though many health experts admit the number of available test kits remains insufficient. The CEPS implements the directives received by the competent ministers. A large percentage of medical costs are reimbursed when you are subscribed to the French social security system, but most of the time prescribed medicines and services are not completely reimbursed. Directive 2001/62 on the prevention of entry into the legal supply chain of falsified medicinal products. We focus on medical devices which are prescribed in the outpatient setting in the public system. A report issued in October 2018 by the national delegates on access to care issued a series of recommendations, including: France has maintained a strict ban on euthanasia, despite a handful of high-profile cases in recent years that have sparked intense public debate, including within the medical profession. AFSSAPS, or French Health Products Safety Agency): responsible for all safety decisions concerning health products and for monitoring products once released in the market. Social welfare services and associations. Products used for disinfecting premises and for dental prostheses are not considered to be medicinal products. Pharmaceutical products eligible/ineligible for reimbursement. Inscription on the List of Reimbursable Drugs (Article L. 162-17 of the Social Security Code). Prices for non-refundable specialities are completely unregulated, as are distribution margins. The unprecedented sanitary and economic crisis stemming from the COVID-19 virus pandemic has intensified the problem of financing French healthcare (the “Social Security gap”), a subject omnipresent in the media. In the event of refusal to include a product on the list of reimbursable drugs, it is possible to bring an appeal for exceeding powers before the administrative judge. Upon a reasoned request from the Minister of Health or Social Security to the Commission, this period may be reduced to one month. Exceptions apply, as products may already be sold while the application is being submitted or evaluated (e.g., Germany and Austria). The “flat rate of responsibility” aims to cover equivalent products in terms of efficiency (generic drugs) on the basis of a single tariff, based on the of the least expensive generic drugs. In the States concerned, while parallel trade may benefit intermediaries and social protection bodies, patients can be exposed to supply disruptions in the French market. This is why, on January 1, 2000, France introduced universal health coverage (CMU), today known as PUMa, for low income households to ensure access to health insurance and that everyone has effective access to care. Please see our terms and conditions page for further details. For example, during the first months of the new coronavirus outbreak, COVID-19 tests were fully reimbursed only for people presenting symptoms of the virus, or the “contact cases” that doctors certified were exposed to someone carrying the virus.