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Managing Scientific Collaboration Agreements within the French Healthtech Sector

Scientific Collaboration Agreements allow a public servant, most of the time a researcher, (who continues to carry out his or her duties as a main activity); to provide scientific support to the Healthtech sector; where he can utilise the research work he has carried out in the public sector.

The law PACTE has introduced many changes in this regime and allows the researcher to acquire an equity stake in the company where he is providing research. The following are answers to the questions posed by the professionals in the Healthtech sector as a result of this reform.

What are the different stages for a Scientific Collaboration Agreement?

The establishment of a Scientific Collaboration Agreement requires:

  • The granting of an authorisation by the supervisory authority of the researcher for a period of 3 years, renewable within the limit of a total duration of 10 years. In order to obtain the authorisation, the researcher sends a written request to his or her supervisory authority which includes at least the following information: (i) the identity of the company; (ii) the nature, duration, frequency and conditions of remuneration of the activity, and any other relevant information. The authority may invite the researcher to provide further information.
  • The conclusion of a Scientific Collaboration Agreement between the company and the supervisory authority, setting out the conditions of work of the researcher concerned in the company, in particular the proportion of working time that the researcher may devote to the company.
  • The conclusion of a Valorisation Agreement between the company and the public entity or entities within which the research works have been carried out, setting out, the financial conditions likely to preserve the interests of the public research service.

What is the annual amount that a researcher can receive for their scientific collaboration?

The annual amount of additional revenue that the researcher may receive from the company under the Scientific Collaboration Agreement may not exceed 74 732.73 euros. [1]

How much can the researcher devote to the scientific collaboration?

The researcher may provide scientific assistance to a company within the limit of 50% of his or her working time. [2]

What should be done in the event of a takeover or change of shareholder of the company throughout the duration of the Scientific Collaboration Agreement?

Any substantial change in the conditions of exercise or remuneration of the activity is treated as a new activity and must be the subject of a new authorisation application. [3] A substantial change may consist of a change in the nature of the employer, the nature of the activity, the duration, frequency and terms of remuneration.

When the company to which the researcher provides scientific assistance is subject to a change of shareholding, the conditions for granting the authorisation may be modified. It is therefore sometimes necessary for the researcher (i) to obtain a new authorisation and/or (ii) to sign an amendment to the initial scientific collaboration agreement or a new agreement.

In the event of a buy-out, the supervisory authority will re-examine the conditions for issuing the scientific collaboration authorisation and may refuse it for several reasons:

  • Authorisation for scientific collaboration for this new company would be prejudicial to the normal functioning of the public service;
  • The researcher’s participation would be detrimental to the dignity of his or her functions or would risk compromising or calling into question the independence or neutrality of the service; and
  • Taking an interest in the company would be likely to harm the material and moral interests of the public research service or to call into question the conditions for carrying out the expert mission that the researcher performs for the public authorities or the management mission that he or she performs.

In order to anticipate any refusal by the supervisory authority, it is suggested you contact the researcher’s supervisory authority directly to explain the situation.

Who controls potential conflicts of interest?

Since the law PACTE, the supervisory authority has the option, and no longer the obligation, to request the opinion of the Haute Autorité pour la transparence de la vie publique (formerly the Commission de déontologie de la vie publique) within one month of the researcher’s application. The Haute Autorité will verify that the conditions for granting the authorisation are met, that none of the three grounds for refusal above have been met.

What are the applicable texts?

The mechanism of scientific collaboration is governed by many legal provisions: articles L. 531-8 and seq. of the French Research Code, as modified by law no. 2019-486 dated 22 May 2019 known as the law PACTE, as well as the implementing decree no. 2019-1230 dated 26 November 2019 and decree no. 2020-69 dated 30 January 2020 on ethical controls in the civil service.

 

[1] The gross annual pensionable salary corresponding to the second chevron of the group outside scale E.

[2] Pursuant to article 5 of the implementing decree no. 2019-1230.

[3] Pursuant to article 14 of decree no. 2020-69.

 

Written by
Emmanuelle Porte
Emmanuelle Porte
As a Corporate partner in the Bird & Bird Life Sciences team in Paris, I mainly advise innovative companies financed by venture capital, in particular biotech/medtech, digital health, and wellness companies.

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