On 17 June 2014, the French government implemented one of the measures adopted by the Strategic council for the healthcare sector, which was created in 2004 to promote dialogue between the French state and the healthcare industry.
To accelerate and ease the implementation of clinical trials sponsored by the industry in France, the government had undertaken to adopt a standard clinical trial agreement (the Standard).
The Standard is intended to be used as a starting point in order to decrease the time spent in drafting and negotiation of such agreements. It is also likely to simplify the contractual relationship of parties involved in multicenter studies, as the same agreement will apply to each healthcare center involved in such study. The Standard will therefore govern the relationships between the sponsor, the investigator, the coordinating healthcare center and associated centers.
The Standard is the response by the French government to the concerns expressed by the industry that France should remain attractive for clinical trials. The Standard is therefore not deemed to totally change market practice. However, the provisions are reduced to the bare minimum. International policies in place within pharmaceutical groups may have to be adapted to take into account the new wording of the transparency provision contained in the Standard, because these provisions are deemed to be mandatory, which will likely create certain concerns for companies being used to their own templates.
In practice, companies (and healthcare centers) already had their own templates and healthcare centers used template fixed fees for the calculation of additional costs. The main innovation is the time frame imposed on healthcare centers. The coordinating center must acknowledge reception of the complete file within 5 days and provide its first comments within the next 15 days and, in total, the period during which the coordinating center provides its comments should not extend beyond 20 days. However, timing for the company to review and comment on the draft will supplement such time frame. Negotiation will take place only with the coordinating center. Significantly, healthcare centers will be ranked and incentivized by additional funding from the State to comply with this timeframe and involve as many patients as possible.
In addition, the new text provides that sponsors may propose a financial incentive to healthcare centers aimed at fostering the inclusion of patients in the trial.
It does not provide for any separate remuneration for the investigator, which does not prevent the entry into of separate consultancy agreements with investigators outside of the scope of the trial.
In summary, the Standard adopted by the French government on 17 June 2014 appears to be a very positive sign to the industry, showing that close cooperation between the State and the industrial sector is successful. Cooperation will continue in the yearly review of the Standard among the representatives of healthcare centers and healthcare industry. It will be key to gather practical comments on the Standard in order to amend it where necessary.
In practice, it will take some time for healthcare centers and companies to be up to speed. The Standard will not apply to on-going agreements but will be used in any new multicenter clinical trial agreement. A question remains as to the extent to which the Standard will also be used when trials only involve one single healthcare center, and its application to private healthcare centers involved in a multicenter trial.
The Standards have been prepared and will be executed in French. Please contact us should you require an English translation.