Law n° 2009-879 of 21 July 2009 is known as the “HPST Law” [relating to Hospitals, Patients, Health and Territories] and was partially implemented by Orders of 2 and 31 August 2010 (specifically relating to therapeutic education and to training programmes). The HPST Law modifies Le Code de la Santé Publique (CSP), creating Articles L.1161-1 et seq. which concern ‘therapeutic education’.
‘Therapeutic education’ (PET) (defined in Article L.1161-1 CSP) is a set of practices that aim to teach the patient some skills so that the patient becomes more active during his illness, with regard to care (how to take medicine, etc.) and monitoring. It is used in chronic illnesses such as diabetes or asthma where the patient has an active role.
A PET has to conform to a national specification as defined by the Health Minister. It is then effected at a local level once the authorisation has been given by l’Agence Régionales de Santé (ARS). The authorisation is valid for a period of four years but it can be renewed for the same period by the Director General of the ARS at the request of the holder of the authorisation. If a PET is implemented without first obtaining this authorisation then a fine of EUR 30,000.00 may be imposed.
A patient must also give their written consent to their involvement in the PET. The patient must also be informed that their information may only be used with their consent; and that they are free to leave the PET whenever they choose.
‘Accompanying actions’ form part of a PET. The object of these is to give help and support to patients, or their relatives, in dealing with the illness. As with the PET, they must conform with a national specification as defined by the Health Minister.
The PET and the accompanying actions must be developed and implemented by health professionals. Within the therapeutic education framework there can be no direct contact between the drug companies or medical device companies, and the patient and their relatives. The only involvement of drug companies, medical device marketing companies, or other companies offering health-related services must be restricted to the financing of the PET.
Training programmes (PA) are designed to improve the medical care of the patient and to teach the patient the proper use of their medication. The PAs can be implemented at the request of l’Agence Française de sécurité sanitaire des produits de santé (AFSSPS), or the European Commission.
A PA is designed in line with the recommendations of the AFSSPS and the Haute Authorité de Santé and will be led by an operator chosen and approved by the drug company, which will finance the programme. All information on the PAs must be separated from any promotional communication concerning the drug which is the subject of the programme, and there can be no direct communication between the drug company and the patient (as with the PET). Although the PA is being financed by the drug company, it will actually be implemented by health professionals on behalf of the operator.
For a PA to go ahead, it must first be authorised by the Director General of the AFSSPS. Authorisation is subject to various conditions, in particular, the existence of a benefit to the patient, and to the non-promotional nature of the programme. Once the authorisation is granted, it is valid for three years, and is then renewable. As with the PET, a patient must also give their written consent to their involvement in the PA.
This legislation is still very new, and it is very unclear how it will work in practice. Most of the arrangements for implementation of the PETs remain to be specified, and numerous points remain unresolved, in particular the role of the ARS in the setting up of financing of the PET, the implementation of the accompanying actions and the extent of the involvement of the drug and medical device companies. The imprecise, still incomplete, measure, along with the multitude of involved authorities and stakeholders, suggests that the new system will not be implemented smoothly.