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It can submit a favourable or unfavourable opinion or a request for some additional information. Another option is to file for a temporary authorisation of use. Extract from the article, “the patent and the brand, two invaluable sesames” on the official website of pharmaceutical industry (. Article R. 163-14 of the Social Security Code provides that refusal decisions are notified to the company along with the grounds of refusal, legal remedies and periods. Falsified Medicines are fought at both the national and the European Union level with a broad legislative framework, notably: Drug counterfeiting is also combatted through the general rules that aim to protect intellectual property rights, which involve police and customs authorities as well as civil and criminal law courts. According to law, the time for the process should be 180 days but could also take longer. Second Step - Enlistment on the LPPR, a positive reimbursement list. Exceptions apply, as products may already be sold while the application is being submitted or evaluated (e.g., Germany and Austria). T: reimbursement systems in 2 countries which differ to a great extent: France, as a country with a defined, centralized reim-bursement process, and Italy, which is organized regionally and less transparent in its reimbursement approach. 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. At all hospitals in France, the general procedure is to pay up front, file your claim, and then get reimbursed. However, it does not cover every healthcare cost – that’s why 90% of the population has voluntary/complementary private health insurance, which covers the remaining expenses. 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. The request is reviewed by the HAS’ Commission on Transparency, which assesses the medical service provided (e.g. The content of this website is for general information purposes only and does not purport to provide comprehensive full legal or other advice. 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. 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. Only products and techniques that have received stringent regulatory approval are reimbursed by the state, while some of those that have not been covered by optional supplementary insurance policies are usually offered as part of employment contracts. The number of doctors and nurses per capita is close to the OECD average, but the number of hospital beds is much higher (6.1 beds per 1,000 inhabitants in France, compared to 4.7 beds on average). +44 (0) 1242 696 790, IDR Medical North America Boston, Massachusetts 02110, USA 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. The first step to ensure that a medical device has market access is to gain certification by a notified body. This material is intended to give an indication of legal issues upon which you may need advice. These associations claim a lack of transparency in the development, manufacturing and marketing of medicines. RESULTS: France In France, the pricing and reimbursement process is agreed at a national level, with few restrictions at regional and local levels. 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. 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. EU Pricing & Reimbursement Newsletter 1 Welcome to this special edition of the Hogan Lovells EU Pricing & Reimbursement newsletter. To ensure product reimbursement, there are three essential criteria that must be fulfilled: coding, coverage and payment. France’s Social Security system is ranked the best by the World Health Organization among its 191 members according to a study published by the British medical journal The Lancet in April 2017. 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. Several factors can affect the price of drugs in France. 20 examples: The reimbursement system has been changed from the government's financing the… Regular readers of the Newsletter will be aware that in the much vaunted French health system you do not normally get full reimbursement of your costs. +41 (0) 61 535 1109, IDR Medical UK In this list, products are designated with their own brand name. Order the print edition of Pricing & Reimbursement 2020 or read free online, Order the France chapter of Pricing & Reimbursement 2020 in PDF format or read free online, View Basket The main problem is the very low level of reimbursement: 120 Euros for the public system and 350 Euros on average for optional complementary healthcare insurance. Prices for non-refundable specialities are completely unregulated, as are distribution margins. Possibility for pharmacists to dispense certain medicines. – Belgium and France have product specific reimbursement with national pricing decision for some technologies (implants/medical aids) 6 ... reimbursement system 1 2 1 2 1. Secondly, the nominative authorisation is requested by the doctor to the benefit of a specific patient, who may not participate in biomedical research. In Europe, a CE mark ensures that medical devices meet the European Directives requirements. Funding usually is through the groupe homogéne de séjour (GHS) Reimbursement and Funding Flow for Biologics Reimbursement is agreed at a national level following the assessment by the This is why intellectual property is one of the fundamental elements in the development of innovation. AFSSAPS, or French Health Products Safety Agency): responsible for all safety decisions concerning health products and for monitoring products once released in the market. France’s drugs assessment agency wants simpler, stronger rules to evaluate the cost-effectiveness of new drugs. Caisse Nationale d’ Assurance Maladie (CNAM), reimbursement status must be granted by Commission de Transparence (Transparency Commission), and a reimbursement price negotiated with Comité Economique du Médicament (CEM) All registered pharmaceuticals are subjected to Evaluation of Therapeutic Benefit Cannabis will be prescribed by doctors specialising in the diseases concerned and working in multidisciplinary referral centers. 22 Scenario 1: Standard Pathway to change the weight / tariff of a DRG Year 1 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. Such complementary plans, or Mutuelles, are financed by member contributions and organised as a non-profit-providing solidarity and assistance for its clients (Article L. 111-1 of the Mutual Societies Code). These authorisations are granted for a limited period not exceeding one year, though they can be renewed. Pharmaceuticals pricing and reimbursement policies in Europe WHO TBS – October 2016 A possible solution • Managed Entry Agreements (MEAs), (Klemp et. To enable the reimbursement of a pharmaceutical product, companies must obtain a product marketing authorisation. Specialised establishments for accommodating patients with specific needs, such as neurovascular units or centres for obese patients. There are several levels of medical service provided (major, moderate or low) that affect the reimbursement rate of the drugs. Global Legal Group Ltd. and the contributors accept no responsibility for losses that may arise from reliance upon information contained herein. But changes to the country’s complex reimbursement system may be too slow to address immediate budget concerns, making pan-European bulk buying appear a more likely near-term solution. 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). The distribution margin corresponds to margin of the wholesaler, margin of the pharmacist and fees for the dispensation. It’s financed through employers and employees’ payroll contributions and taxes. public) pay for the product or service delivered by healthcare professionals. Prescription drugs are reimbursed by GKV with a fixed patient copayment, depending on package sizes. According to the Leem organisation that represents drug companies, France imported €18.3 billion worth of medicines in 2017. Hospital drug prices were completely unregulated until 2003 and were the result of negotiations between laboratories and hospitals. In 2016, employees paid around 8% of salary while employers paid around 13%. On April 26, 2016, the Competition Authority issued an opinion on the online sales of medicine. The reimbursement process usually starts with the manufacturer applying for reimbursement before the launch of their product (e.g., France, Italy, and Spain). simplifying liberal practice and freeing up medical time. The price of the original is often also cut by laboratories themselves, in order to keep their product competitive. Prescribed drugs are covered entirely or partially by the health insurance system. If patients insist on the brand-name product, they must pay the full price immediately, and claim reimbursement later. Shortcomings of the French reimbursement system. 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%. The authorisation request must be filed or it will be subject to a commitment to be filed within a specific period. reimbursement amount, patients have to pay any difference between the market price and the maximum reimbursement amount. drugs that do not mention on their packaging, labelling, leaflet or advertisement a therapeutic use. This was because testing kits were in short supply in many countries after the outbreak struck. In France, some pharmaceutical products require a medical prescription while others can be bought without a prescription (over-the-counter) depending on the composition of the medicine or its use. United Nations Secretary-General’s High Level Panel Report of the United Nations Secretary-General’s High Level Panel on Access to Medicines, September 14, 2016. For the retail pharmacist’s margin, several coefficients are applied according to the different tranches of the product’s pre-tax manufacturing price (ministerial order dated December 12, 2017): Part of the pre-tax manufacturer price between, Evolution of the sales of reimbursable drugs in pharmacies1, Sales, pre-tax manufacturer price (billion euros), Sales, public price including tax (billion euros. The presence of generic and biosimilar drugs on the market. 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. Prices decrease in tandem for both the generic and the original, since the prices of generics are calculated according to the price of the original, and apply to the pre-tax manufacturer’s price. Commission Delegated Regulation 2016/161 on how medicine authenticity should be verified. The public price of drugs for consumers is composed of the pre-tax manufacturer’s price, profit margins (wholesaler’s margin, official margin and dispensation fees) and the value-added tax. Where the notice relates to the listing, amendment of listing conditions or renewal of the listing of a drug on the list of reimbursable specialties or on the list of drugs approved for community use, the notice is communicated immediately to the drug’s producer. The experimental treatments will be reserved for a limited number of patients whose symptoms can not be relieved by other medications. There are two types of discounts: conventional; and unconventional. Small differences in coverage remain among different NHI … The French population has a high life expectancy of 82.8 years, slightly exceeding the average for all OECD countries (82.4 years). In France, there is a fast-track pathway, which provides reimbursement within the framework of the prospective medico-economic study, aiming at demonstrating benefits to patients or reduction of expenditure of health care system. The move would widen the financing gap by €136 billion, compared with an estimated gap of not more than €4 billion for 2019. The reimbursement rate depends on the medical service provided for the drug. Providers of compulsory or supplementary health insurance plans. 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. T: 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 national health insurance programmes are characterised by compulsory participation that reflects French goals of solidarity between generations and professions. Their 3 core missions are scientific evaluation, laboratory control and advertising control. As seen above, the public price includes profit margins that are applied to wholesalers and pharmacists, which can fluctuate. 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). 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. The marketing authorisation is issued by either: The product marketing authorisation must be accompanied by a summary of the product characteristics, as well as its labelling and packaging, and the accompanying information notice. The reimbursement rate applies to the current sale price (or “flat rate of responsibility”) that is a reference rate for the reimbursement of drugs in a particular category. Supplementary schemes – “Mutuelles” offered by private insurance companies, insurance cooperatives or other groups – are often focused on particular professions and provided via a person’s employer, though individuals can also search out separate providers. Hospital-only products, which are mostly reimbursed from the total health care budget allocated to the hospital, are not subject to assessment by CEPS. The study used a mixed methods approach including primary data collection through a questionnaire addressing the competent It’s financed through employers and employees’ … The French healthcare system is widely considered to be one of the most comprehensive and technically advanced in the world. 225 Franklin Street, 26th Floor The CEPS implements the directives received by the competent ministers. The national health insurance programmes are characterised by compulsory participation that reflects French goals of solidarity between generations and professions. Price or volume clauses represent a combined 41% of the total discounts, an amount of €409 million. It will then be available, from next year, in pharmacies, in the form of capsules, oil or dried marijuana flowers. 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. However, no matter where you go, the reimbursements should be the same. Contributions are therefore based on income, and access to care defined according to need. Drugs with medical service rendered insufficient compared to other available drugs or therapies are not included on the list of reimbursable specialties. In France, manufacturers are free to … Many people do so because in general, the system does not fully refund doctor visits, drug prices or other treatments. 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. The role of COMEDIMS, a subcommittee set in every hospital/group of hospitals, is to enlist and decide which devices to buy for their respective hospitals. 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. 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. The regulatory rules came into force on February 9, 2019. Article L. 162-16-5-1 of the Social Security Code contains provisions regarding discounts for drugs which benefit from a temporary authorisation of use. The draft law on the organisation and transformation of the health system opens up the possibility for pharmacists to dispense certain medicines currently on prescription. Public health institutions: the French system is managed by the Minister of Health and the Minister of Social Affairs. The healthcare reimbursement system in the US is the process whereby either Commercial Health Insurers (i.e. It sets the support rate of healthcare as well as the reimbursement rate of drugs. More generally, the re-emergence of infectious diseases raises the question of both the long-term and short-term effects on pricing and reimbursement. Drugs sold directly to the health establishment: the price is negotiated directly by health establishments. Considering the issue of the cost of virus prevention, the government is coordinating a plan of free access to masks for the beneficiaries of the CSS. 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. This is because, unlike in the UK 'capitation' system, where the payment model to doctors is based on the number of patients, in France it is a fee based system that is used.

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