- The French Sunshine Act
During the second part of 2011, the French government decided to review the current French Health Product system following the Mediator scandal. Law No.2011-2012 on sanitary safety of medicinal and Health products was adopted on 29 December 2011. This law aims among others at restoring the confidence in the decisions taken by the French Authority and the transparency in the relationships between the industry and healthcare professionals. Law No. 2011-2012 inserts a new Article L.1453-1 in the French Public Health Code (CSP) on the disclosure of agreement signed and any financial advantage offered to healthcare professionals, patient group or hospitals.
Decree No. 2013- 414 dated 21 May 2013 lays down the implementation provisions of Article L.1453-1 of the CSP. These new provisions came into effect on 1st June 2013. At this date, the companies had to disclose all the agreements signed and advantages granted in 2012 on their websites and on the websites of the professional Societies according to transitional provisions until the creation of a unique website for disclosure held by the Ministry of Health. The unique public website was created by an order dated 3 December 2013. Since the publication of the Order in the Official Gazette on 19 December 2013, the companies can directly report the disclosures on this unique website.
The unique website should be accessible to general public on 1st April 2014.
According to the provisions of new article L.1453-1 CSP, pharmaceutical companies must disclose the existence of agreements that they concluded with:
- healthcare professionals,
- associations of healthcare professionals,
- students in medicine and odontology,
- associations of patients,
- health establishments,
- press organs for health professionals for all media (press, radio, TV or online communication);
- Medical prescription and deliverance software editors;
- Learned societies.
Above a limit of 10 euros all taxes included, the obligation of disclosure also applies to the advantages in nature or in money granted directly or indirectly by pharmaceutical companies to the above listed recipients. Consequently, all advantages granted to persons listed above that are above 10 euros will have to be disclosed.
Each company must disclose the following information for each agreement concluded:
- Identity of the parties to each agreement
- If a healthcare professional: Name, qualification, title, speciality, registration number at the Professional Society, personal identification in the shared register of healthcare professionals and the professional address;
- If a company: name, legal status, corporate purpose and address of the head-quarter.
- The date of the execution of the agreement
- The subject-matter of the agreement, drafted to maintain the secret protected by law and in particular the industrial and commercial secret
- If the agreement relates to hospitality in the framework of an event, the program of the event.
For the advantages granted, each company must disclose the following information:
- Identity of the recipient of the advantage and of the company with the details mentioned above
- The amount of the advantages all taxes included, the date and the nature of the advantages received by the recipient during a civil semester
- The civil semester concerned.
Te companies will have to transmit the above-mentioned information to the unique website within 15 days from the execution of the agreement and at least on 1st August of each year for the advantages granted during the 1st semester of the year and at least on 1st February of each year for the advantages granted during the 2nd semester.
The authority must then disclose the information on the website for the 1st semester of the year on 1st October and for the 2nd semester on 1st April.
- The EFPIA Code on Disclosure of Transfers of Value
In parallel to this national transparency system, the European Federation of Pharmaceutical Industries and Associations (EFPIA) decided to enhance transparency around relationships with healthcare professionals and healthcare organisations. On 24 June 2013, the EFPIA Board adopted a Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations, to be implemented in national codes of good practices by 31 December 2013.
The EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations requires all members of EFPIA to disclose transfers of value to healthcare professionals and healthcare organisations as of 2016 regarding all transfers made in 2015.
Indeed, according to Article 3 of the EFPIA Code, each company shall disclose, on an individual basis for each clearly identifiable recipient, the amount attributable to transfer of value to such recipient.
Each member company will have to document and disclose on its website, or on a common website:
- The names of healthcare professionals and associations that have received payments or other transfers of value
- The amounts or value transferred, and the category of relationship, such as consultancy fees, payment for travel, congress fees, donations.
- The implementation of the EFPIA Code on Disclosure of Transfers of Value in France
During the autumn 2013, the French Syndicate of Pharmaceutical Companies (LEEM) examined how to implement both the new French provisions and the EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations in its Code of Ethics. Indeed, the French legal transparency framework has a broader scope than the EFPIA Code. The main differences between the two sets of provisions are that the EFPIA Code requires:
- the disclosure of the amounts of the agreements concluded with healthcare professionals and healthcare organisations and
- the disclosure of the aggregate amounts for research and development transfers of value per year.
On 20 November 2013, the LEEM decided to implement the EFPIA Code in two successive steps:
- first step: before 31st December 2013, the integration in the LEEM Code of Ethics of the French provisions on disclosure of interactions with healthcare professionals without any implementation of any additional provisions from the EFPIA Code;
- second step: during the year 2014, implementation of the additional provisions issued from the EFPIA Code concerning:
- the aggregate amount of R&D expenses per company
- the financial amount per year provided for remuneration of services or agreements.
According to the LEEM, the implementation of these additional provisions may raise competition law issues and data protection issues.
Consequently, before implementing these provisions, the LEEM will request the opinion of both the French Competition Authority (“Autorité de la Concurrence”) and the French Data Protection Committee (CNIL).
Indeed, the CNIL already rendered an opinion on the legal requirements for disclosure on the unique website. An opinion on the additional provisions of the EFPIA Code regarding their compliance with the French Data Protection Act seems necessary.
Based on these two opinions, the LEEM will decide in the course of 2014 on the additional implementation to be done of the EFPIA Code in the light of the existing French transparency provisions.
In practice, it stays that, at least for the time being, a company will have to file information on two different websites, which means once more a raise of administrative tasks.