Introduction
Current public health institutions
Advantages of agency system
Drawbacks of agency system
Commission's recommendations



Introduction

Unlike in many countries where public health and safety issues are monitored by the government, in France this falls under the remit of specific institutions known as 'safety agencies' – that is, public bodies that are distinct from the government, but which have a public service mission. On July 6 2011 a report on these safety agencies was published by the Commission on Social Affairs.(1)

The report was issued in a difficult context, with some safety agencies' independence having been questioned by the public as a result of recent sanitary scandals. The commission's conclusion was lukewarm: the French system of safety agencies is unique and has clear advantages, but a number of limits have been exposed and need amending.

The acknowledgement in the report that the current system has some issues is a significant one, since these safety agencies were originally created to answer criticisms aired in the 1990s about how the government was handling public health issues. For instance, the Medical Products Agency (the predecessor to the current Health Products Safety Agency) was created after the growth hormone scandal.(2) The French Blood Agency (the predecessor to the current French Blood Establishment) was created by the same law in response to the contaminated blood tragedy. Similarly, mad cow disease(3) encouraged the creation of the Food Safety Agency (now replaced by the French Agency for Food, Environmental and Occupational Health Safety).

Current public health institutions

The existing health institutions are:

  • the Health Products Safety Agency;
  • the Agency for Food, Environmental and Occupational Health and Safety;
  • the Economic Committee for Health Products;
  • the French Consumption Council;
  • the Consumer Safety Commission;
  • the General Directorate for Competition Policy, Consumer Affairs and Fraud Control;
  • the National Authority of Health;
  • the High Council for Public Health;
  • the National Institute for Prevention and Health Education;
  • the National Institute of Blood Transfusion; and
  • the Institute for Public Health Surveillance.

Advantages of agency system

The main advantages of the French system that were underlined by the commission in its report are:

  • the separation between assessment and management of health risks;
  • the separation between economic regulation and safety management;
  • management flexibility; and
  • clear demonstration of political priorities.

Separation between assessment and management of health risks
The first advantage in setting up safety agencies is that the assessment and management of health risks are separated. While the safety agencies undertake risk assessments with the benefit of their multidisciplinary scientific expertise, it is the government's responsibility to take appropriate decisions in light of the agencies' findings. This is different from the United States, for example, where the Food and Drug Administration carries out both assessment and management of health risks. The French system is said to be more neutral and better protected against strong lobbying thanks to this separation of powers.

Separation between economic regulation and safety management
The second advantage is that this system ensures that any health-related decision is impartial, because the regulation of economic factors and the monitoring of safety are carried out by different actors. For instance, three different actors take part in the marketing process of a drug:

  • the Health Products Safety Agency assesses safety on the grounds of a risk-benefit balance;
  • the National Authority of Health is in charge of providing an opinion on the actual clinical benefit in order to help central government to make decisions on reimbursement for medicinal products; and
  • the Economic Committee for Health Products is responsible for pricing after negotiations with key stakeholders.

Management flexibility
The third advantage is flexibility in the management of both financial and human resources. Safety agencies are not obliged to employ public servants only; they can recruit private experts/scientists and offer them attractive wages. This structure also allows for different sources of funding, which means that these agencies do not face the same economic restrictions as other exclusively state-funded agencies. By way of example, the Health Products Safety Agency collects many different taxes including a tax on drugs and a tax on applications for authorisation to market.

Clear demonstration of political priorities
Finally, the symbolic value of these agencies for the public must not be underestimated. The implementation of a new safety authority is a way for politicians to show their determination to fight a specific problem. That is why, for example, the Blood Agency was created in 1993. The current Mediator scandal can serve as another example; this drug developed for treating overweight diabetics could have induced fatalities before it was finally banned in 2009. The government has prepared a draft bill in order to replace the Health Products Safety Agency with another safety agency: the National Agency for Drug Safety.(4) The draft bill was submitted to Parliament on August 1 2011 and will be debated before the end of 2011.

Drawbacks of agency system

Notwithstanding the advantages noted above, the French system of safety agencies is being criticised for its complexity and its lack of independence.

Complexity – variations in status
Not all safety agencies have the same status, which adds complexity for companies which do not always know which ministry to turn to in case of a problem.

Some agencies are public administration bodies, such as the General Directorate for Competition Policy, Consumers Affairs and Fraud Control,(5) the Health Products Safety Agency and the Agency for Food, Environmental and Occupational Health and Safety. Each of these is under the supervision of a specific ministry.

Others are independent authorities, not related to a specific ministry. These include:

  • the Consumer Safety Commission, whose main objective is to issue recommendations and suggest measures to enhance the prevention of risks associated with products or services;(6) and
  • the National Authority of Health, whose main aims are to:
    • provide health authorities with the information they need to make decisions on the reimbursement of medicinal products and services;
    • encourage good practices and the proper use of health services by professionals and patients;
    • improve quality of care in health care organisations and in general medical practice; and
    • provide information for the public and generally improve the quality of medical information.

Finally, some agencies are consultative bodies only, such as the French Consumption Council and the High Council for Public Health.

Complexity – variations in powers
Not all safety agencies have the same powers, which creates great complexity for companies when interacting with these different authorities. Some agencies are confined to providing advice. In this respect, the French Consumption Council has limited powers. It is a consultative body which works with consumers and professionals who are encouraged to express and confront their opinions. Public authorities are required to consult the French Consumption Council on the broad lines of their policy in the area of consumption (eg, the French Consumption Council's opinion is inevitably required before the enactment of any order relating to prices or advertising of prices).

Other agencies/authorities have much more power. For instance, the Health Products Safety Agency can:

  • implement the law;
  • publish opinions/recommendations;
  • conduct public consultation on subjects of general interest;
  • provide scientific expertise;
  • inform the public of health risks;
  • advise public authorities on any relevant reform to undertake;
  • identify accidents that have occurred;
  • receive complaints from victims; and
  • impose sanctions on manufacturers/producers such as product recalls or corrective measures.

The General Directorate for Competition Policy, Consumer Affairs and Fraud Control has the same powers, except those relating to public consultation and publication of opinions and recommendations.

Complexity - overlapping responsibilities
The French landscape of safety agencies has not come into being as a whole, but results instead from successive regulations enacted following specific health crises. Laws have been enacted on an ad hoc and uncoordinated basis, leading to overlapping responsibilities. This feature has been highlighted by the French Court of Auditors in a report released in February 2011 regarding the health crisis due to the H1N1 influenza pandemic in 2009.(7)

For example, in the area of blood safety, three agencies can be involved: the French Blood Establishment, the National Institute for Blood Transfusion and the Health Products Safety Agency. It is a similar situation with medicinal products where the Health Products Safety Agency and the National Authority of Health have complementary tasks: indeed they both have to assess the quality of drugs.

Another example arises in connection with cosmetic products. Several agencies monitor the safety of sunscreen products: the Health Products Safety Agency, which is competent to monitor cosmetics,(8) has issued several opinions and decisions regarding ultra-violet filters contained in sunscreen products(9) and has published on its website a good practice guide.(10) The Consumer Safety Commission also provides good practice guides regarding a wide range of cosmetic products including sunscreen products on its website.(11) Furthermore, the General Directorate for Competition Policy, Consumer Affairs and Fraud Control also carries out studies regarding sunscreen products(12) and the National Institute for Prevention and Health Education has published its own recommendations.(13)

However, efforts have been carried out to make the French landscape of safety agencies more comprehensible, for example, through merging complementary agencies. For example, the Agency for Food, Environmental and Occupational Health and Safety was created in 2010(14) as a result of a merger between two French safety agencies: the Food Safety Agency and the Agency for Environmental and Occupational Health Safety.

Further mergers are awaited. In a legislative report published in October 2010 on independent authorities, it was recommended to "clearly define the distribution of powers between administrative authorities in the same field of competence in order to avoid any duplication".(15) This view is supported by the July 2011 report, which, for instance, suggests combining the complementary missions of the Institute for Public Health Surveillance with those of the National Institute for Prevention and Health Education.(16) The latter agency(17) is in charge of implementing national health programmes; its main task consists of informing and arousing public attention on public health problems.

Lack of transparency and independence
The strong link to various ministries and the fact that these agencies receive public funds have been criticised. Indeed, their independence is regularly questioned. However, huge efforts have been made to enhance their independence. For instance, in many safety agencies, experts are required to sign a commitment to respect ethical rules and they are appointed only once their public disclosure of interests has been examined. In July 2011 the Health Products Safety Agency has launched a specific web portal to permit online consultation of any declarations of interest.(18) All declarations of interest of the Agency for Food, Environmental and Occupational Health and Safety experts are also available online.(19)

Commission's recommendations

In the light of these drawbacks, the Commission of Social Affairs is recommending that 17 changes be implemented. These includes:

  • clarifying the role of each agency (eg, identifying in a clear way which agency focuses on research, which one focuses on control of the market);
  • organising internally each agency in the same way and increasing internal controls;
  • ensuring greater transparency and independence of these agencies by forcing them to report to the government and by making their accounts/reports available to the public;
  • improving media attention in relation to the findings of these agencies and developing the types of expertise available in each agency; and
  • implementing stricter control and supervision by the government.

This report should be discussed by Parliament shortly in order to enable reform of the safety agency system.

For further information on this topic please contact Sylvie Gallage-Alwis or Perrine Bertrand at Hogan Lovells (Paris) LLP by telephone (+33 1 53 67 47 47), fax (+33 1 53 67 47 48) or email (sylvie.gallage-alwis@hoganlovells.com or perrine.bertrand@hoganlovells.com).

Endnotes

(1) Legislative Report 3627 on safety agencies.

(2) Law 93-5 of January 4 1993.

(3) Bovine Spongiform Encephalopathy (BSE).

(4) Article 4 of the draft bill 3714 of August 1 2011.

(5) For more details about the General Directorate for Competition Policy, Consumer Affairs and Fraud Control, see Thomas Rouhette and Sylvie Gallage-Alwis, "Product Safety in France: current trends and key points for successful cooperation with the French authorities", International Product Liability Review 40, September 2010, p10.

(6) Article L534-5 of the Consumer Code.

(7) "Campaign against the pandemic H1N1 influenza: review and lessons to be learned", February 2011.

(8) Article L5311-1 of the Public Health Code.

(9) The Health Products Safety Agency's opinion regarding the use of Benzophenone-3 (CAS 131-57-7) in sunscreen products issued on July 8 2011; The Health Products Safety Agency's decision regarding the ban of 3-Benzylidene camphor (CAS 15087-24-8) in cosmetic products issued on August 24 2011.

(10) The Health Products Safety Agency's good practise guide regarding the use of sunscreen products issued on July 4 2011.

(11) Opinion 03/90 on sunscreen products labelled 'total protection'.

(12) See the General Directorate for Competition Policy, Consumer Affairs and Fraud Control's practical guide regarding sunscreen products (January 2011).

(13) www.inpes.sante/fr.

(14) Ordinance 2010-18 dated January 7 2010.

(15) Legislative report 2925 of October 28 2010 on independent authorities (recommendation 11).

(16) Legislative report 3627 of July 6 2011 on safety agencies (recommendation 1).

(17) Created by the law of March 4 2002.

(18) https://icfidnet.afssaps.fr/Public/index.php.

(19) www.anses.fr/.

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