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FrancePosted 03/08/2012

First posted: 3 August 2012 

France is a developing market* in the use of generic medicines. Generic medicines have been in use in France since 1996 [1].

France is one of the leading drug manufacturers in the world and is an important research and development site for major multinationals. There are more than 300 pharmaceutical manufacturers in France, including 12 generics companies, employing around 100,000 people [2, 3]. The market is the third largest in the world with a market share of 5.6% in 2008 [3].

The development of a generic drug market in France has been very slow. The weak response to generics is partly due to the already low prices of brand-name drugs in France compared with other European countries. In the 1990s, France adopted legislation extending the period of patent protection, which delayed the development of generics [4].

Traditionally, generics do not account for a significant proportion of the French pharmaceutical market. However, government policies to reduce the healthcare budget deficit provided new impetus to the generics sector in the last few years. Nevertheless, the government has introduced few incentives to encourage generic prescribing. The main impetus has come from pharmacy substitution, driven by higher margins obtained on generic products and discounting by manufacturers. Generics entering the market must be priced 50% below the original brand price. This makes the French generics market less lucrative than that in, for example, Germany. In summary, companies considering entering the French market need to balance the high biologicals use and high generics market growth against low prices and low acceptance of generics [5].

In comparison with other Western European countries, France is one of the countries spending more on medicines. In 2008, a total of 16.2% of the total healthcare budget was spent on medicines compared to only 9.8% in The Netherlands and 7.7% in the UK [6].

In 2011, Euros 29.62 billion was spent on medicines by France [2].

The French generics market is small by international standards. In 2009, only 23.7% of prescriptions in France were dispensed as generics, accounting for 10.9% of the market value [7].  In France, generics represent 38% of the pharmaceutical market in terms of volume and 15% in value, with the French retail generics market valued at US$4.1 billion in 2009 [Mylan, 2010].

France has pricing regulation of generic medicines, included in the reimbursement system, which means that penetration of generic medicines is less successful than in countries that permit (relatively) free pricing of medicines, e.g. Germany, The Netherlands, UK [4, 8].

In 2007, there were around 1,240 generic medicines with market authorisation in France [3].

Generics entry leads to an approximate 37% decrease in the generic medicines price in France two years after entry to the market. Average prices for the originator medicines losing exclusivity, however, appear to remain stable two years after generics entry [9].

Generic medicine prices are relatively low compared to many other European countries [4].

Generics substitution by pharmacists is allowed but not obligatory. Pharmacists are granted a financial incentive in the fact that they receive the same amount of money in remuneration as they would get for the originator product [10]. In 2010, the generics substitution rate by pharmacists nationally averaged 80% [11]. This is considered to be the main driver of generic medicine market development in France [12].

Patient co-payments tend to be covered by private insurance, therefore no incentive exists for patients to demand cheaper (generic) medicines in France [13].

The social health insurance (Délégués d’Assurance Maladie, DAM) organises information activities on a regular basis targeted at patients in order to increase awareness of generic medicines [10].

At the moment, parallel imports are not significant in France. The market is quite limited, with fewer than 10 market authorisations in 2007 [3]. Due to its relatively low price levels, France is a primary source for parallel trade to other countries [4].

France has a high number of generics producers present in the market, making the generic segment of the pharmaceuticals market in France appear rather fragmented [14].

Key facts – contribution of generic medicines to France

  • Generics substitution in France produced savings of Euros 1 billion for the health insurance system in 2008 [15].
  • The generics industry supplies 23.7% of dispensed medicines at 10.9% of the cost [7].
  • Generic medicines are 30–50% cheaper than their branded equivalents [16].
  • In 2009, an average of Euros 468 per head of population per year was spent on medicines in France compared to an average of Euros 382 in Western Europe [2, 17, 18].
  • Increased substitution of generics for the top ten originator medicines could reduce public expenditure on the originator medicines in France by 35% [13].

* In countries with developing generic medicines markets, market share of generic medicines does not surpass 40% [19].

References

1.  Générique Même Médicament (GEMME). Le médicament générique: un peu d’histoire. [The generic drug: a little history].  [monograph on the Internet]. Paris, France, GEMME [cited 2012 Jun 10]. French. Available from: www.medicamentsgeneriques.info/le-medicament-generique/un-peu-dhistoire

2.  Business Monitor. France Pharmaceuticals and Healthcare Report Q4 2011. 2011 Sep 28.

3.  Van Ganse E, Chamba G, Bruet G, Becquart V, Stamm C, Lopes S, Marty C. Pharma profile France. Pharmaceutical Pricing and Reimbursement Information (PPRI). 2008 Jul. Available from: http://ppri.oebig.at/Downloads/Results/France_PPRI_2008.pdf

4.  Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Surveying, assessing and analysing the pharmaceutical sector in the 25 EU Member States. 2006 Jul.

5.  Pisani J, Bonduelle Y. Opportunities and barriers in the biosimilar market: evolution or revolution for generics companies? [monograph on the Internet]. Brussels, Belgium, European Generic medicines Association (EGA); 2006 [cited 2012 Jun 10].

6.  Nefarma. Feiten en cijfers [Facts and figures] [page on the Internet]. The Hague, The Netherlands, Nefarma [cited 2012 Jun 10]. Dutch. Available from: www.nefarma.nl/feiten-en-cijfers

7.  Agence française de sécurité sanitaire des produits de santé, AFSSAPS (French Medicines Agency). Les ventes de medicaments aux officines et aux hôpitaux en France: chiffres-clés 2009. [Sales of drugs to pharmacists and hospitals in France: key figures 2009].  6th ed. 2010 Oct. French.

8.  Simoens S. Generic medicine pricing in Europe: current issues and future perspective. J Med Econ. 2008;11(1):171-5.

9.  European Commission. DG Competition Staff Working Paper. Pharmaceutical Sector Inquiry Preliminary Report. 2008 Nov 28. Available from: ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/preliminary_report.pdf

10.  Vogler S, Schmickl B. Rational use of medicines in Europe. Gesundheit Österreich GmbH/Österreichisches Bundesinstitut für Gesundheitswesen (GÖG/ÖBIG). 2010 Feb.

11.  Mutualité Française. Favoriser les génériques dans tous les départments. [Promote generics in all departments]. [monograph on the Internet]. Paris, France, Mutualité Française [cited 2012 Jun 10]. French. Available from: www.mutualite.fr/L-actualite/Kiosque/Revues-de-presse/Favoriser-les-generiques-dans-tous-les-departements/(language)/fre-FR

12.  Bongers F, Carradinha H. European Generic medicines Association (EGA) Health Economics Committee. How to increase patient access to generic medicines in European healthcare systems. 2009 Jun.

13.  Simoens S, De Coster S. Sustaining generic medicines markets in Europe. 2006 Apr. [monograph on the Internet]. Brussels, Belgium, European Generic medicines Association (EGA); [cited 2012 Jun 10]. Available from: www.egagenerics.com/doc/simoens-report_2006-04.pdf

14.  Glowicka E, Lorincz S, Pesaresi E, Sauri Romero L, Verouden V. Generic entry in prescription medicines in the EU: main characteristics, determinants and effects. 2009 Jul 8.

15.  Mutualité Française.. Le succès des génériques. [The success of generics] [monograph on the Internet]. Paris, France, Mutualité Française [cited 2012 Jun 10]. French. Available from: www.mutualite.fr/L-actualite/Kiosque/Revues-de-presse/Le-succes-des-generiques/(language)/fre-FR

16.  Mutualité Française. Les médicaments génériques décollent en 2007. [Generic drugs take off in 2007]. [monograph on the Internet]. Paris, France, Mutualité Française [cited 2012 Jun 10]. French. Available from: www.mutualite.fr/L-actualite/Medicament/Bon-usage/Les-medicaments-generiques-decollent-en-2007/(language)/fre-FR

17.  European Federation of Pharmaceutical Industries and Associations (EFPIA). The pharmaceutical industry in figures. Edition 2010.

18.  ABPI. Did you know? Facts and figures about the pharmaceutical industry in the UK [homepage on the Internet]. UK, ABPI [cited 2012 Jun 10]. Available from: www.abpi.org.uk/our-work/library/industry/Documents/Did%20you%20know_Jan11.pdf

19.  Simoens S. International comparison of generic medicine prices. Curr Med Res Opin. 2007;23(11):2647-54.

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