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Encouraging direct access to OTC drugs in France

Country: 
France
Partner Institute: 
Institut de Recherche et Documentation en Economie de la Sant (IRDES), Paris
Survey no: 
(14) 2009
Author(s): 
Pichetti, Sylvain
Health Policy Issues: 
Pharmaceutical Policy
Current Process Stages
Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no no yes no no

Abstract

Self-medication drugs are commonly used to treat symptoms of common illnesses that may not require prescription of a physician. Until 2008, prescription-free drugs could not be purchased directly off the shelf in pharmacies. The Ministry of Health legalized direct access to over-the-counter drugs (OTC) in pharmacies in 2008 in order to develop the self-medication market. This policy aims to enable patients to treat common diseases themselves and introduces price competition for OTC drugs.

Purpose of health policy or idea

Self-medication drugs are drugs which do not require a physician's prescription and which are not reimbursed by the Health Insurance Fund. 

 

Compulsory prescription

Optional prescription

Reimbursed by health insurance fund

 

 

Not reimbursed by health insurance fund

 

SELF-MEDICATION


The French Ministry of Health decided to legalize access to a list of over-the-counter (OTC) drugs in pharmacies in July 2008 (decree n°2008-641, 30 June 2008).

Pharmacies can now dispose a list of non-prescription products over the counter, which means on the shelves directly accessible by clients. This would allow patients to see and compare prices, which are not regulated for OTC drugs. Indeed the price of the same medication can vary significantly between pharmacies even within the same area. 

 In France the French Agency for the Safety of Health Products (Agence Française de Sécurité Sanitaire des Produits de Santé -AFSSAPS) decides which products could be sold OTC to ensure that these products are safe when used without a physician's prescription. The list contained 302 drugs in 2009, concerning mostly painkillers, antitussive drugs, ENT, dermatological, gastroenterological, ophthalmological and anti-smoking treatments often not proven to be effective.

Nevertheless, the sale of OTC drugs is regulated and pharmacies have the monopoly to sell these drugs. Their sale in general stores (supermarkets, etc.) is not allowed. While the prices of drugs on the positive list are negotiated between pharmaceutical companies and the Economic Committee on Health Products, there is no regulation for OTC drug prices. Patients are often unaware that prices can be different from one pharmacy to another as they are not displayed.

Main points

Main objectives

The main purpose of this policy is to promote a self-medication market in France, which was not very developed until recent years. Self-medication consumption represented 27 Euros per person and per year in France in 2005 whereas it represented 60 Euros in Germany and 40 Euros in the United Kingdom and in Italy (Coulomb & Baumelou, 2007). In Anglo-Saxon countries, patients usually buy OTC drugs to treat common diseases themselves instead of consulting their general practitioner. In this context, encouraging self-medication in France is seen as one way of reducing physician consultations for common diseases. A decrease of the frequency of consultations devoted to common illnesses should help to save time for general practitioners to cure more serious diseases.

Moreover, developing self-medication encourages patients to assume more responsibility, which is in line with the patient empowerment concept. One principle of the empowerment concept is that health belongs to the individuals and consequently individuals have the prime responsibility for their own health. In this context, self-medication is seen as one way (with the project of the electronic medical file, see HPM 11/2008) of giving patients more responsibility.

Furthermore, this policy will induce price competition between pharmacies that should result in a price decrease for certain OTC products.  Customers can now compare prices for the same OTC product between several pharmacies in order to buy the treatment at the lowest price.

Type of incentives

No incentive is provided by the law. Pharmacists are free to accept or refuse the measure. If they do, they have to display OTC drugs in a specially-dedicated, clearly identified space situated in the surroundings of the counter in order to enable patients to ask for advice by the pharmacist. Moreover, pharmacists have to display on the shelves instructions from public health authorities to inform patients on safety precautions. As a matter of fact, one way to encourage self-medication use is to improve patient's access to appropriate and secure information on drugs that can be used without consulting a doctor.

There are no penalties for pharmacists who do not display OTC drugs. Those who display expect to attract patients and increase sale volumes.  

Groups affected

Pharmacists, patients, pharmaceutical firms, general practitioners and the health insurance fund.

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Characteristics of this policy

Degree of Innovation traditional neutral innovative
Degree of Controversy consensual highly controversial highly controversial
Structural or Systemic Impact marginal rather marginal fundamental
Public Visibility very low high very high
Transferability strongly system-dependent system-dependent system-neutral

Political and economic background

In France as in other European countries, the government is under pressure to control health expenditure. Concerning drug consumption, there is a French paradox:  the French are among the highest drugs consumers in Europe for many therapeutic classes, while the French self-medication market is one of the least developed in Europe. Encouraging self-medication is seen as one way of reducing physician consultations for common diseases and consequently health expenditure.

In France, drugs prices are mainly determined by negotiations and consequently do not result from competition on the market. After the Commission of Transparency of the French National Authority for Health determines whether a new drug should be reimbursed, a separate entity called the Economic Committee on Health Products negotiates prices with drug companies. Only drugs that have been assessed by the Commission of Transparency as yielding added therapeutic value over existing therapy can be granted a price higher than comparator drugs. Drugs for which the Commission of Transparency has not recognized added value can only be reimbursed if they are priced cheaper than comparators.

On the other hand there is no price regulation for OTC drugs. In that context, the OTC market constitutes one area where price competition can apply.

Purpose and process analysis

Current Process Stages

Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no no yes no no

Origins of health policy idea

The idea was first described in an official report for the French Ministry of Health  (Coulomb & Baumelou, 2007). This report outlined the advantages of displaying OTC drugs in pharmacies in order to develop a French self-medication market. The project was then supported by the French Ministry of Health.

Initiators of idea/main actors

  • Government
  • Providers
  • Patients, Consumers
  • Private Sector or Industry

Approach of idea

The approach of the idea is described as:
new:

Stakeholder positions

The vast majority of pharmacists were first strongly opposed to this measure because they thought that this is a first step towards the end of the pharmacist monopoly in France.  French pharmacists feared that OTC drugs would be shortly available in general stores or supermarkets. The French Ministry of Health tried to assure pharmacists that this is not their intention.

Moreover, pharmacists opposed to the measure argued that free access to OTC drugs would generate public health problems. In an attempt to justify their role in the system they argued that when using OTC drugs without advice from a pharmacists, patients may combine different ones with their prescription medicine, potentially causing drug interactions if the substances are incompatible. Patients may also take multiple OTC drugs containing the same active ingredient which could lead to an overdose or increased side-effects.

Some pharmacists were opposed to the measure only for practical reasons: the implementation of the measure needs the pharmacy to be large enough to create a specially-dedicated place to expose OTC drugs. It is very difficult for small pharmacies to display OTC drugs in a specially-dedicated space even if the pharmacist is not against the measure.

On the contrary, pharmacists who implemented the measure believe that this is going to increase their sales.

Patients are more or less supportive.  First studies tend to show that younger people are more receptive to this measure than older patients. This difference may be explained by the fact that older patients consult more frequently their general practitioner and consequently are less concerned with OTC drugs. Visiting a general practitioner allows them to get a prescription for drugs which are reimbursed instead of buying non-reimbursed OTC in their pharmacy. On the contrary, younger people consult less frequently their general practitioner and are consequently more receptive to OTC drugs.  

Some patients still hesitate to buy OTC drugs and prefer to have advice from the pharmacist. Studies show that urban customers consume OTC drugs more frequently than rural ones. But all patients criticize the lack of information concerning the implementation of this measure.

The Health Insurance Fund hopes for a decrease of general practitioner consultations for common illnesses in order to save money on patient's reimbursements.

Pharmaceutical firms expect an increase of OTC drugs sales. Pharmaceutical firms can propose their drugs to be registered on the list defined by the regulatory agency AFSSAPS.

General practitioners were mainly opposed to the measure since they are not necessarily informed of patients' OTC drug consumptions. They think they can misinterpret biological results and make diagnostic mistakes. Furthermore, self-medication development possibly induces a decrease of their activity.

Actors and positions

Description of actors and their positions
Government
French Ministry of Healthvery supportivevery supportive strongly opposed
Providers
General Practitionersvery supportiveopposed strongly opposed
Patients, Consumers
Patientsvery supportivesupportive strongly opposed
Private Sector or Industry
Pharmaceutical firmsvery supportivevery supportive strongly opposed
Pharmacistsvery supportivestrongly opposed strongly opposed

Actors and influence

Description of actors and their influence

Government
French Ministry of Healthvery strongvery strong none
Providers
General Practitionersvery strongnone none
Patients, Consumers
Patientsvery strongweak none
Private Sector or Industry
Pharmaceutical firmsvery strongstrong none
Pharmacistsvery strongweak none
Pharmaceutical firmsFrench Ministry of HealthPatientsGeneral PractitionersPharmacists

Positions and Influences at a glance

Graphical actors vs. influence map representing the above actors vs. influences table.

Results of evaluation

In September 2008, about 20% of French pharmacists had displayed OTC drugs in a specially-dedicated, clearly identified space. By October 2009 this percentage went up to about 47%. Given that the measure was not compulsory for pharmacists, this could be seen as a significant result.

According to IMS Health data, average price for OTC drugs has decreased of about 3.2% between April 2008 and January 2009. Hence, the objective of price competition seems to be realized even if some economists say that it could have been more pronounced.

Expected outcome

Until now, the frequency of general practitioner consultations did not decrease; maybe the results would be more spectacular if the proportion of pharmacists adopting the measure was higher. It is also possible that there is no trade-off between OTC drugs and GP visits and they satisfy different cliental/needs.

Impact of this policy

Quality of Health Care Services marginal marginal fundamental
Level of Equity system less equitable neutral system more equitable
Cost Efficiency very low neutral very high

The measure does not have any impact on quality of care. And until now, there is no reason to worry about any equity side-effects since the concerned drugs are mostly inexpensive and considered to be ineffective. But if the list of OTC drugs is extended to more expensive and more effective drugs, equity problems would arise. Until now, the frequency of general practitioner consultations did not decrease; cost efficiency can currently be rated as neutral.

References

Sources of Information

(2009). Déjà un an de libre accès !  Moniteur des Pharmacies et des Laboratoires (Le), (2786:2787) : 20-26.

Attal-Toubert K., Vanderschelden M. (2009). La démographie médicale à l'horizon 2030 : de nouvelles projections nationales et régionales.  Etudes et Resultats,            679 -8.

Baumelou A., COULOMB A. (2007). Situation de l'automédication en France et perspectives d'évolution : marché, comportements, positions des acteurs : Paris : la documentation française.

http://lesrapports.ladocumentationfrancaise.fr/BRP/074000030/0000.pdf

Author/s and/or contributors to this survey

Pichetti, Sylvain

www.irdes.fr/EspaceRecherche/Equipe/Pichetti.htm

Suggested citation for this online article

Pichetti, Sylvain. "Encouraging direct access to OTC drugs in France". Health Policy Monitor, October 2009. Available at http://www.hpm.org/survey/fr/a14/3