Life Sciences: What's new in France?

The convention unique for commercial clinical trials involving human individuals

Key points

The convention unique aims to simplify and accelerate the implementation of commercial clinical trials between private sponsors and French health care establishments by providing a simple and mandatory template reducing transaction costs. With this tool, the government hopes to increase France’s competitiveness in biomedical research.

While the convention unique had remained in the experimental stage for a few years, the 2016 National Heath Law enacted on January 6, 2016 compelled the set up of the convention unique for all new clinical trials started after November 17, 2016.

What?

The convention unique is a mandatory template for agreements between health care establishments, care homes or health centres (“Health Care Institution”) and sponsors for the operation of commercial clinical trials involving humans.

The new convention unique system entered into force with the implementing decree of November 16, 2016. This mechanism derives from a former template created by an administrative instruction on June 17, 2014 that only applied to public Health Care Institutions.

While the new rules have clarified the scope and implementation mechanisms of the convention unique, certain aspects remain unclear, such as the notions of counterparties and eligible third parties and the convention unique’s interaction with public procurement rules.

Who?

The convention unique is entered into between the sponsor and the Health Care Institution. If the parties intend to compensate a third party (in the conditions described below), this third party must also sign the agreement.

If the research is conducted in multiple Health Care Institutions, each agreement must contain the same provisions relating to identification, billing and payment that the sponsor’s agreement contains.

Scope?

The convention unique applies to all research involving therapeutic acts on human beings. It channels the financial flows related to the commercial clinical trials and is exclusive of any other agreement for pecuniary interest.

Which obligations?

The sponsor must provide the products used for the clinical trial free of charge.

The sponsor must also bear the following costs:

• the defined costs incurred by the Health Care Institution generated by the implementation of the clinical trial which do not relate to the patient management (such as logistical, administrative or investigation costs, etc…); and
• the “extra costs” corresponding to all patient management costs entailed by the implementation of the clinical trial.
  

The ministerial order of November 16, 2016 provides the convention unique template and describes in detail how to calculate these costs.

In addition, the convention unique may provide for compensation related to the expected quality of the research data. This compensation may be either directly paid to the Health Care Institution or to a third party entity participating in the research that is not under the Health Care Institution’s legal representative’s authority provided that said third-party:

• is appointed by the Health Care Institution’s legal representative pursuant to public procurement law;
• has adequate governance to prevent from incurring any liability; and
• uses the compensation for research purposes.
  

This new mechanism permits the compensation of associations and supersedes the former inclusion incentive.

When?

The convention unique shall be signed within 45 days after the Health Care Institution receives the sponsor's proposal. When the trial takes place in several sites, an additional 15 days period applies for any agreement with associated establishments. The target is ambitious but a recent survey shows that, despite the adoption of the convention unique, the implementation of clinical trials still takes too long.

Finally, it is important to bear in mind that the sponsor must transmit the convention unique after signature, for information purposes, to the National Council of Physicians (Conseil National de l'Ordre des Médecins, the “CNOM”).

Transparency-related obligations for animal health stakeholders

Key points

In this era of reform in the pharmaceutical industry, the veterinarian industry has also been subject to strengthened transparency requirements.

The law on the Future of Agriculture, Food and Forestry enacted on October 13, 2014 (the “FAFF”) introduced a legal framework to regulate the potential conflicts of interest between animal health stakeholders and veterinary drugs manufacturers. The FAFF has transposed the transparency and anti-gift requirements, applicable to the pharmaceutical industry, to the animal health sector.

An implementing decree dated December 20, 2016 specifies the procedure under which specific agreements are subject to an advisory opinion from professional bodies and a decree dated January 26, 2017 provides for the disclosure requirements. Both decrees become effective on July 1, 2017.

Benefits prohibited

There is a general prohibition for animal health stakeholders (such as pharmacists, veterinarians, students in these sectors, groups that organize the livestock product, companies manufacturing and marketing medicated feedingstuffs, associations representing these entities, etc.) from receiving any benefits, in kind or in cash, granted by companies manufacturing, importing, exporting or marketing veterinary medicinal products.

Companies proposing or granting such benefits may be fined up to €37,500 and the receiving person may be fined up to €4,500. Individuals may also be disqualified from practicing as a veterinarian or pharmacist.

Agreements subject to an advisory opinion

When veterinarians or pharmacists (or students in these sectors) contemplate entering into agreements with concerned companies whose purpose is to provide hospitality (hosting of professional and scientific events) or research or scientific assessment activities, the concerned companies must submit the agreements to the National Council of Veterinarians or the competent local council of pharmacists for an advisory opinion before the agreements are signed or implemented. The professional body reviewing the agreements must give its opinion within two months.

In addition, concerned companies must notify the professional body that they are implementing the agreements within one month from the start of implementation.

Agreements subject to disclosure

Companies manufacturing or marketing veterinary medicinal products or providing related services must also disclose their relationship with animal health stakeholders (such as veterinarians, pharmacists, students in these sectors, educational institutions, academies, foundations, learned societies, consulting agencies and medias, etc.) on the public transparency website. The companies must comply with this obligation every six months – on or before September 1 for the benefits granted during the first semester of that year and on or before March 1 for the benefits granted during the second semester of the preceding year.

The public transparency website will publish the benefits granted and their nature, the name of the beneficiaries, the date of signature of the agreement, the date on which the benefits are granted, and the purpose of the agreement. If the agreement is for hospitality, the organizer, its name, the date and the place of the event must be disclosed.

Companies that voluntarily do not comply with their disclosure obligation may be fined up to €45,000.

New age of anti-gift and transparency-related obligations

Key points

The French regulatory framework governing the relationships between companies manufacturing or marketing health care products intended for human use (the “Companies”) and health care stakeholders continues to experience significant changes.

After the recent stepwise transparency reform, the 2016 National Health Law, enacted on January 26, 2016 (the “Health Law”), substantially reformed the French anti-gift law for the first time since 1993.

While two different sets of rules still apply to Companies dealing with health care stakeholders (namely the anti-gift law and the so-called French “Sunshine Act”), the rules are now converging into a single transparency regulation.

I. What has changed in the Anti-Gift Law?

The French anti-gift law of January 27, 1993 (the “Anti-Gift Law”) is the first founding text regulating the Companies’ relationships of interests with health stakeholders. An ordinance adopted on January 19, 2017 (the “Ordinance”) strengthens the requirements arising from the Anti-Gift Law. In particular, it extends the scope of the prohibition and creates an authorization scheme from the relevant professional body above certain thresholds.

The new provisions become effective on a date to be fixed by decree or, at the latest, on July 1, 2018.

Extending the ratione personae scope

The Ordinance extends the scope of the prohibition with respect to the individuals within its purview.

Any person or company manufacturing or marketing health care products or providing health services is now subject to the prohibition, regardless of whether the person or company’s products are reimbursed or not.

The Ordinance also broadens the range of people banned from receiving prohibited benefits by including all health care professionals covered by the French health public code and adding osteopaths, chiropractors, psychotherapists, initial and continuing medical education students and civil servants who participate in the development of public health/social security policy or have public health powers (collectively the “HCPs”).

Clarifying the ratione materiae scope

The Anti-Gift Law is broad and prohibits, on a general basis, any benefit, in kind or in cash, of any form. However, the Anti-Gift Law does provide for specific exemptions to this general prohibition rule. The Ordinance clarifies the nature of these exempted benefits:

• any remuneration, compensation and reimbursement of expenses provided by an employment agreement or an agreement for the exercise of the HCP’s professional activity provided that they concern directly and exclusively the HCP’s professional activity;
• benefits resulting from the use or transfer of intellectual property rights relating to health care products;
• commercial benefits granted under commercial agreements for the purchase of goods or services; and
• benefits in kind or in cash relating to the exercise of the HCP’s professional activity that do not exceed a negligible value to be determined by ministerial order.
  

Amending the submission procedure

The new provisions distinguish between agreements subject to a mere declaration and the agreements subject to authorization based on the amount of the benefits and the operations concerned. A forthcoming implementing order will determine the thresholds upon which a declaration or authorization will be required. While the thresholds are yet to be determined, the authorization will change and will require companies will in any case need to review their internal organization. This system is intended to increase legal certainty, but its success will depend upon its content and implementation.

Listing the exemptions from the prohibition

The Ordinance lists the following operations as exempt from the general prohibition so long as the submission is followed:

• any remuneration, compensation and reimbursement of expenses related to research, commercialization of research, scientific assessment, consulting, commercial promotion activities, to the extent that the remuneration is proportionate to the services and the compensation or reimbursement of expenses does not exceed the costs effectively incurred by HCPs;
• donations and gifts whose purpose is the funding of research activities;
• donations and gifts to associations gathering HCPs (or students of the sector);
• reasonable hospitality for professional or scientific events or promotional events; and
• the funding of professional training.

Strengthening the sanctions

The Ordinance doubles the fine incurred by any person offering prohibited benefits for non-compliance with the Anti-Gift Law requirements. Individuals are now subject to a two-year jail sentence and a fine up to €150,000. Companies are subject to a fine up to €750,000. Alternatively, the fine may be increased to 50% of the expenses incurred in carrying out the offence.

Any person receiving prohibited benefits may be subject to a one-year jail sentence and a fine of up to €75.000.

II. What changes to the transparency obligations?

The so-called “Loi Bertrand” enacted on December 28, 2011 (the “Sunshine Act”) aims at increasing transparency through disclosure on a public website of the Companies’ links of interest with health stakeholders. A decree of December 30, 2016 (the “Decree”), adopted further to the Health Law, has enhanced these transparency requirements.

Enhancing the disclosure requirements

The Decree broadens the content of the information that must be disclosed concerning agreements whereas no change is made to the scope and information to be disclosed with respect to the benefits granted.

In addition to the information already subject to disclosure, the following additional information must be disclosed regarding agreements:

• the expiry date (if known at the time of the signature);
• the precise purpose of the agreements according to a specific typology defined by a ministerial order of March 22, 2017;
• if the agreement is for hospitality, its organizer, its name, the date and the place of the event;
• all potential indirect and final beneficiary (the co-contracting party bears responsibility to identify all potential direct and final beneficiaries and to report the relevant information to the entity in charge of filing the information); and
• the total amount of the agreement.
  

Any remuneration for an amount of €10 or more paid under the concerned agreements are also subject to disclosure and the following information must be disclosed:

• the beneficiary;
• the date;
• the amount, rounded to the nearest euro, of all remuneration paid during a specific semester to the beneficiary which may be specified in the relevant agreement ; and
• the semester during which the remuneration is paid.
  

Harmonizing the frequency of disclosure

The Decree harmonizes the frequency of disclosure as follows:

• on or before September 1 for the agreements concluded/the benefits granted during the first semester of that year; and
• on or before March 1 for the agreements concluded/the benefits granted during the second semester of the preceding year.
  

The Decree provides that remunerations must be disclosed on each payment due date in accordance with the provisions of the agreements, which would conflict with this harmonized frequency. The French Pharmaceutical Association (Les Entreprises du Médicament, the “Leem”) issued guidelines on February 6, 2017 conveying the French Health Ministry’s position on this issue that the remuneration must be disclosed according to the harmonized timeframe. 

The timeframe for complying with transparency requirements

The implementing order to which the Decree refers to for the entry into force of the new transparency requirements was issued on March 22, 2017.

However, the Leem explains in its guidelines that, since the implementing order was issued after February 1 – the date by which the Companies had to disclose data related to the second half of 2016 – it is unlikely that the new requirements have retroactive effect for remuneration granted pursuant to an agreement concluded in 2016.

Companies should nonetheless get ready to comply with the new requirements for the first semester of 2017 on September 1 this year.

Shared medical record

Key Points

Under the umbrella of the national health strategy, the French Ministry of Health has prioritized e-health to provide the core infrastructure needed to enable health information sharing and exchange. French authorities recognize that the health system must leverage information systems and digital services in order to improve the coordination of care and foster through innovation.

To that end, the personal medical record was created in 2004 but was not implemented until 2011 and has not been efficient since its implementation. With the 2016 National Health Law (the “Health Law”) of January 26, 2016, this record has been reinstituted, improved and renamed to “shared medical record” (dossier medical partagé, the “SMR”).

The record finally entered into force following the adoption of a first decree dated July 4, 2016 specifying the implementation rules for the opening, managing and closure of the SMR, and a second decree dated November 16, 2016 authorizing the processing of the SMR by the National Health Insurance Fund for Employees (Caisse Nationale d’Assurance-maladie des Travailleurs Salariés) (the “NHIFE”).

We believe the SMR will be an important step in accelerating various modernizations of our health system, from substitution to telemedicine.

Content of the SMR

The purpose of the SMR is to make a digital file containing certain medical information for each patient available to health care professionals in order to improve “prevention, continuity and coordination of medical care”.

The SMR contains administrative information (such as the patient’s identifying number, address, telephone number) and medical information related to the patient’s medical history, test results, vaccines etc.

All health care professionals must report the diagnostic and therapeutic information for each medical intervention or consultation necessary for the coordination of the patient’s medical care in the SMR.

The Health Law has added two new categories of data to the SMR:

• data related to the health care reimbursement history necessary for the coordination of patient’s medical care; and
• bridging sheets (fiches de liaison) to be completed each time a practitioner refers a patient to a health care facility.
  

What control over the SMR does the patient have?

Any beneficiary of the national health insurance can create an SMR on his/her own. If the SMR is created by a health care professional, he/she must obtain the patient’s prior informed and express consent, which may be obtained in a dematerialized form.

Pursuant to the 1978 Data Protection Law (Loi Informatique et Libertés), the patient has a right of access to his SMR and a right of rectification of the information stored. Although the patient may ask the health care professionals to rectify the data for a legitimate reason, he cannot directly delete data reported by health care professionals. The patient can restrict access to his SMR to the health care professionals he chooses, but his referring physician is entitled to access.

The patient may decide to close his SRM at any time, but the data will be kept for ten years following the closure of the SMR.

A staged implementation

The NHIFE plans to adopt a staged approach for the implementation of the SMR, starting with private practice practitioners, then hospitals, private hospitals and eventually hosting facilities for elderly and dependent people (établissement d'hébergement pour personnes âgées dépendantes).

A strengthened governance

Considering the importance of information systems to the NHIFE, SMR processing has been transferred from the Shared Information Systems Agency (Agence des systèmes d’information partagés) to the NHIFE to generate synergies.

This is meant to accelerate the effective launch and use of the SMR as NHIFE is also in charge of open data projects for health data.