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Health and medical services to France

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(Last updated: 11 Jan 2008)

Trends and opportunities

Market overview

With a population of 61.5 million people (of which 10.11 million are aged over 65), France represents the second largest European market for medical care after Germany. Over the last 30 years, new healthcare technologies and products have contributed to an increase in life expectancy of eight years. 


France ranks sixth in the world in terms of medical density, with approximately 335 healthcare professionals for every 100,000 French residents. There are 234,739 practicing doctors, of whom 102,330 are general practitioners.


The French social security system has been accumulating a deficit over the past 25 years. This problem is causing the French Government increasing concern. Due to the heavy cost of the social security system (the deficit is estimated at A$14.6 billion for 2007), the French Government is encouraging self-medication, particularly through the use of generic medicines. The government is also implementing some cost-containing reform programs for the health sector which include new measures to control spending on medical devices.

Market structure and functioning

The French healthcare system is based on the principle of free choice of medical treatment. Patients choose their doctors, pay them directly and claim for reimbursement afterwards. The amount of reimbursement represents a percentage of the standardised fees set by the social security administration, which may vary according to the services.


Ninety-nine per cent of the French population are covered by the Statutory Health Insurance, a branch of the Social Security System. There are different schemes depending on the social and/or professional category of the individuals. Eighty per cent of the French population are protected by the General System, which covers employees and pensioners from trade and industry sectors.


Medical expenses are covered as following:

  • The French healthcare system covers 75.5 per cent of all medical expenses
  • Private households – 11.3 per cent 
  • Private health insurance – 10.1 per cent 
  • Provident societies – 2 per cent 
  • Other government – 1.1 per cent

The French market for medicines is divided into prescription-only, or non-prescription, over-the-counter (OTC) products. The large size of most of the pharmaceutical companies is due mainly to the need for substantial (and expensive) research and development, combined with high product sophistication, which pushes laboratories to merge.


Homeopathy is recognised by the French healthcare system, and remedies are reimbursable under applicable rules. However, only prescribed medicines are reimbursable. Sales of homeopathic remedies with potencies beyond 30C are forbidden.


There are public and private hospitals and both sectors are expanding. The main sources of income for hospitals are:

  • Social security – 90 per cent 
  • Households – 6.6 per cent 
  • Complementary private insurance – 2.3 per cent
  • General public – 1.1 per cent

In general, the number of qualified medical staff in France is increasing. However, the trend for non-medical staff has stagnated and in some sectors, such as anaesthesia-reanimation and obstetrics, there is a shortfall in qualified specialists.


The Hospital Federation of France represents 2500 public hospitals with a total of around 470,000 beds, ie. 65 per cent of the French market. This association undertakes marketing activities, such as the promotion of public healthcare to the general public and propositions to hospitals.

 

The 'Carte Vitale' is a plastic smart-card that is progressively replacing the paper social insurance card. Use of the Carte Vitale is becoming more widespread but unfortunately not all healthcare professionals have the required equipment to read the card and be linked to the national network.

Opportunities

Australian companies have already been successful in France with medical devices such as surgical instruments, disease diagnostics and software, however, broader opportunities exist. 


Telemedicine, non-invasive surgery, orthopaedic equipment, and surgical and medical instruments are areas in which demand is expected to grow sharply in the next years.

Medical devices

France is the fourth largest medical device market in the world behind USA, Japan and Germany. The market value in 2007 is estimated to be A$8.1 billion. France spends 2.9 per cent of its health expenditures on medical equipment which represents 0.3 per cent of total GDP.

The market operates with a negative trade balance as imports outweigh exports in most major product groups. This deficit reached A$923 million in 2006. France, however, has a positive balance for radiology equipment and X-ray film. Between 1998 and 2002, exports increased faster than imports. This trend has slowed since 2002 and imports are now increasing at almost the same rate as exports. Eighty per cent of the medical device consumption is derived from imports. Since 2002, the value of both imports and exports almost doubled and around two-thirds of French medical imports are now sourced from Europe, up from 46 per cent in 2001.

There is a myriad of sectors in this niche market, each with a marginal market share. For each product, specific manufacturing and distribution skills are needed. Examples of sectors, which offer potential for Australian exporters include:

  • Products designed for the elderly population (eg. incontinence products)
  • Care kits for nurses and medical professionals
  • Surgical equipment
  • Disposable equipment (disposable diagnostic)
  • Hospital waste treatment products

Over the last few years, the medical device sector has been growing at a faster rate than the overall market. Medical device imports in France reached A$8.7 billion in 2006. Not all of those products are for the national market as some are re-exported, eg. pacemakers.

The acquisitions process in the medical industry has opened up new channels for distribution, which favour the importation of foreign-manufactured equipment on the French market. The opportunities for investment in this sector remain strong as the French Government in 2003 launched a A$15.8 billion investment program for French hospitals to modernise and renew their equipment, in particular imaging and radiotherapy equipment.

A similar investment program is planned for 2008-2012. A five-year cancer plan was launched in 2003 and a similar plan for Alzheimer’s disease will start in 2008. To implement the plans, both will require new investments in medical devices. Some activity-based funding has also been implemented. This funding should act as an incentive for hospitals to increase their activity levels, but may consequently reduce the expenditure on equipment that is not reimbursed.

Finally, the increasing proportion of elderly people in the population will also create new demands for home care products and services, such as disposable equipment.

However, there is also a counteracting force in this market, that is, the will to reduce operational expenditure costs and to regulate the medical device expenditure in the same manner as drug expenditure (with reduced reimbursement tariffs). This will obviously restirct the market growth on such devices and supplies.

The medical device market is therefore expected to see limited growth in the future, with its turnover rising from A$8.1 billion in 2007 to an estimated A$10.56 billion in 2012. This nevertheless represents an average growth rate of 5.3 per cent over the next five years.

Fruit extracts and essential oils

French consumers are now more conscious of maintaining a healthier lifestyle and are expressing a desire to ‘return to nature’. The French Government is also encouraging people to self-medicate, which is resulting in a boom in the nutraceutical and functional food and beverage, phytotherapy and homeopathy industries. This market offers great opportunities for Australian exporters as the Australian industry has some unique products in this area, thanks to its rich natural environment.

The major opportunities for Australian services include:

  • Ambulatory/outpatient surgery. This area of medicine has significant potential in France as it provides cost-effective medical services in an environment that is often considered more convenient and less stressful for patients than traditional hospitals.
  • Home healthcare. Home care is a luxury, but with further improvements in technology, this form of healthcare will become available to a larger proportion of the community. For this to happen, improvements are required in the level of equipment sophistication and the level of computerised information management within the French healthcare network.
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Tariffs, regulations and customs

France is part of the harmonised trade system of the European Union (EU). Common Customs Tariff (CCT) will be applicable to goods from non-EU countries, including Australia. The Integrated Tariff of the Community is applicable to goods from non-EU countries, including Australia. Most duties are ad valorem (%), based on the GATT Valuation Code (approximate CIF value).


Before shipping any goods to France, companies should obtain a written customs duty ruling from the French customs service. These rulings are called Binding Tariff Information (BTI). Obtaining a BTI is free and should prevent any conflict over customs or excise duty.


Value Added Tax (VAT) on medical products (equipment) is 5.5 per cent and 5.2 per cent on pharmaceuticals.


Access to the French biotechnology industry is limited by relatively strict national and European Union (EU) legislation. Biotechnology products for healthcare can only be imported through French or European pharmaceutical companies. Biotechnological pharmaceutical or diagnostic products can only be sold by a company located within the EU.


In France there are specific approval processes and licences for medicines and medical devices. It is important to check these procedures and seek advice from:

It is illegal to offer any product for sale or use that has not undergone the correct approval process.


The way products are packaged, sold and/or produced will dictate the tariff(s) that apply:

  • A medicine can only be commercialised after being granted a marketing authorisation delivered by the French Health Products Safety Agency after studies ensuring its efficiency, quality and safety.
  • Medical devices have to conform with European standards and are generally certified by their manufacturer. However, for high-risk items, a pre-market product approval can be compulsory.
  • Medical equipment must be registered on the Ministry of Health list, which complies with the Economic Committee of Health Products Act. Products have to be listed so they can be classified in terms of the benefits they offer patients. This classification takes into consideration:
    • The technical efficiency of the products
    • Their side effects and risk for users
    • Their positioning compared with other products and therapies available on the market
    • The type and characteristics of physical impairment for which the products are prescribed
    • The products’ benefits to public health

Registration on the list has to be completed with the generic description of the product and a list of the product's main major characteristics.

Industry standards

All information about what is required to meet French norms and standards are available from the French Standards Association (AFNOR, Association Française de Normalisation). Medical EC marking must be provided on each product.

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Marketing your products and services

Market entry

Depending on your product and your end-customers some market entry strategies into the health and medical industry in France include:

  • Appointing a distribution partner to handle importing and customer liaison.
  • Managing the customer base from Australia, with a European company warehousing and shipping to the customers.
  • Setting up an office in France.
  • Sending one of your staff to France as a representative.
  • Sharing distribution with another Australian company – preferably with a complimentary product range.
  • Manufacturing your products in France under contract or license.
  • Undertaking a joint venture with a French company.

Most of the Australian companies that have been successful in France have chosen to either set up an office in France, undertake a joint venture with a French company or appoint a distribution partner. Under the last option, the Australian companies benefit from the French distributor’s understanding of the market, their ideas in how best to present the products, their comments on packaging changes (with translations in French) and the placement of the product in the market.

French companies are looking for long-term relationships with their suppliers and working together to achieve sales targets. Thus Australian exporters should consider France as a long-term strategic market.
 

Smaller distribution partners often specialise in a particular product sector and may service customers on a regional basis or may only supply a certain type of customer.


Australian exporters can reduce the difficulties of market entry by fulfilling a specific niche requirement in the market. The medical devices industry has many niche product lines which require specific manufacturing and distribution skills. It is recommended that companies focus on a single product line or on a particular geographical area.


Attending trade fairs in France is also an excellent way to get an industry update. The major European event is Medica.


The following is a list of recommended trade fairs:

  • Le Medec, held annually in Paris, is one of the most important health industry exhibitions in France. It attracts exhibitors and visitors from the following industries: pharmaceutical, medical equipment, medical office equipment, services, medical programs and medical publishing; and industry press and official bodies.
  • Hôpital Expo-Intermédica, held every two years in Paris, is another major healthcare trade fair and attracts around 800 exhibitors. The next exhibition will be held in 2008.
  • Pharmagora is the major trade fair in France targeting the pharmaceutical industry.

The major driver in the French healthcare sector is cost/patient benefit. Almost all new products and services will need to demonstrate the following:

  • Recognised clinical trials
  • Reference sites or case studies
  • Practitioner support
  • Publication in respected industry journals
  • Compliance with European Union and French standards

With specific new products, the best way to introduce yourself to the market is generally by contacting the associations of practitioners and professionals (‘Collèges’). They are key opinion leaders.

While many French business people do speak English, it is imperative that manufacturers’ commercial product literature be translated into French. The promotional material used should clearly illustrate issues, as well as proving technical information about the product or service. Information and communication technologies known as e-medical products must also be available in French.

To sell the product in France, it is necessary that a product meets the requirements for reimbursement. To be eligible for reimbursement, the product not only needs to fulfil all these previous conditions, but manufacturers must also show evidence of their products’ benefits, efficiency or cost saving: 

  • For medical equipment to be eligible for reimbursement it needs to be approved by the French Nomenclature and Pricing Authority.
  • Pharmaceuticals eligible for reimbursement must be sold at a fixed price, established by the Pharmaceutical Economic Committee after negotiations with the manufacturers.

Few technologies will succeed without support from the reimbursement system. The only exceptions would be technologies aimed at the private sector, such as cosmetic surgery.

Pricing information should be provided separately and in Euros where possible.

Due to the strict laws surrounding advertising, only over-the-counter brands are allowed to be advertised to consumers.


Most major companies have incorporated the Internet into their business strategy and have websites with a brochure format for products. Some have added an interactive sales facility for consumers. Business-to-business sales are also well developed in France especially in the pharmaceutical sector.


If you offer your products for sale to France or another European country over the Internet, you will need to comply with French and European laws. Information about using electronic marketing to facilitate your exports is available at e-Market Services.

Distribution channels

The French health and medical distribution network includes three main intermediaries:

  • Manufacturers/laboratories
  • Agents or authorised dealers
  • Distributors

The three major end users are hospitals, pharmacies and the retail sector. Products can be sold via more than one of these channels.


Pharmacies only sell products that have being granted the marketing authorisation (Autorisation de Mise sur le Marché). The French Government does not allow the retail sector to sell medicines, however, supermarkets can offer products considered ‘para-pharmacy products’.  Examples of such products are first aid products (eg. band aids), pregnancy tests, condoms and insect repellents.


The distribution network in the French healthcare industry is keen to implement a barcode system in order to simplify the distribution process. A barcode system is not yet implemented in France due to systems not yet providing the batch numbers and use-by date information.

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Links and industry contacts

Health and medical–related resources

Biofutur – www.biofutur.com
BioMed Central – www.biomedcentral.com 
Doctor’s Guide – www.docguide.com
Egora – www.egora.fr (in French only)
French Agency for Innovation – www.anvar.fr (in French only)
French Pharmaceutical Industry Directory – www.aipef.com
Hosmat – www.hosmat.com
Le mensuel des maisons de retraite (home care) – www.ehpa.fr (in French only)
Moniteur pharmacies – www.moniteurpharmacies.com (in French only)
National Federation of Home Hospitalisation Establishments – www.fnehad.asso.fr
Quotimed – www.quotimed.com (in French only)
Quotipharm – www.quotipharm.com (in French only)
Research Centre for the Healthcare Industry – www.credes.fr

 

Actualité Innovation Médecine (in French only)
24, bis, bd Verd de Saint Julien
92190 Meudon
France

 

Group for the Evaluation of Medical Apparatus
(Groupement pour l'Evaluation des Dispositifs Médicaux - G.Med)
33, avenue du Général Leclerc
92260 Fontenay aux Roses
Tel: +33 (0) 1 4095 6354
Fax: + 33 (0) 1 4095 6243


French Institute of Health and Medical Research
(Institut national français de recherche médicale)
101, rue de Tolbiac
75654 Paris Cedex 13
Tel: +33 (0) 1 4423 6000
Fax: +33 (0) 1 4585 6856


Association of Pharmaceutical Laboratories
(Les Entreprises du Médicament)
88 Rue de la Faisanderie
75016 Paris
Tel: +33 (0) 1 4503 8888


National Association of Medical Doctors
(Conseil National de l’Ordre des Médecins)
180 Bd Haussmann
75389 Paris Cedex
Tel: +33 (0) 1 5389 3200
Fax: +33 (0) 1 5389 3201


National Association of Pharmacists
(Conseil National de l’Ordre des Pharmaciens)
4, avenue Ruysdael
75379 Paris Cedex 8
Tel: +33 (0) 1 5621 3434
Fax: + 33 (0) 1 5621 3499


Research and Development Association for the Pharmaceutical and Biological Industries
43 rue St -Germain
27000 Evreux
Tel: +33 (0) 2 3231 1078
Fax: +33 (0) 2 3231 1078

Government, business and trade resources for France

Ministry of Employment and Solidarity - www.sante.gouv.fr
Legifrance - www.legifrance.gouv.fr
French Health Products Safety Agency - http://agmed.sante.gouv.fr
Ministry of Economy, Finance and Industry - www.euro.gouv.fr


French Food Safety Agency
(Française de Sécurité Sanitaire des Aliments)
23 avenue du Général de Gaulle - BP 19
94701 Maisons Alfort
Tel: +33 (0) 1 4977 1300 
Fax: +33 (0) 1 4977 9005


Directorate General for Competition, Consumption and the Prevention of Fraud
26 rue Louise Weiss
75703 Paris Cedex13
Tel: +33 (0) 1 4487 1717 
Fax: +33 (0) 1 4497 3030


Directorate General for Customs and Excise
(DOUANES - Direction Générale Des Douanes et Droits Indirects)
23 bis rue de l'Université
75007 Paris
Tel: +33 (0) 1 5504 6520 (stat) or 5504 6510 (info)
Fax: +33 (0) 1 5504 6530 (info and stat.)


National Institute for Industrial Property
(Institut National de la Propriété Industrielle)
26 bis, rue de St-Petersbourg
75008 Paris
Tel: +33 (0) 1 5304 5304
Fax: +33 (0) 1 4293 5930

 

French Standards Association
(AFNOR, Association Française de Normalisation)
11, avenue Francis de Pressensé
93571 Saint-Denis La Plaine Cedex
Tel: +33 (0) 1 4162 8000
Fax: +33 (0) 1 4917 9000


Australian Business in Europe (ABIE)
c/o Australian Embassy
4, rue Jean Rey
75724 Paris, Cedex 15 
Tel: +33 (0) 1 4059 3352

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Contact details

The Australian Trade Commission (Austrade) is the Australian Government’s trade and investment development agency, operating as a statutory agency within the Foreign Affairs and Trade portfolio.

Austrade assists Australian businesses contribute to national prosperity by succeeding in trade and investment, internationally, and promoting and supporting productive foreign investment into Australia.

Austrade:

  • Delivers services that assist Australian businesses initiate, sustain and grow trade and outward investment.
  • Promotes Australia as an inward investment destination and, with the States and Territories, supports the inflow of productive foreign direct investment.
  • Administers the Export Market Development Grants scheme.
  • Undertakes initiatives designed to improve community awareness of, and commitment to, international trade and investment.
  • Provides advice to the Australian Government on its trade and investment development activities.
  • Delivers consular, passport and other government services in designated overseas locations.

A list of Austrade offices (in alphabetical order of country) is available.

More information

For further information please contact Austrade on 13 28 78 or email info@austrade.gov.au

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