French Legal and Regulatory Update – May 2026

France –  Addendum to the production obligations agreement between ARCOM and Amazon Prime Video adopted

On 6 May, ARCOM and Amazon adopted a second addendum to the agreement governing Amazon Prime Video's investment obligations.

Pursuant to the French Law of 30 September 1986 on Freedom of Communication, media service providers may enter into agreements with ARCOM to specify their obligations regarding the financing of audiovisual and cinematographic creation. On 9 December 2021, ARCOM and Amazon Digital UK Limited entered into an agreement relating to the Amazon Prime Video service. This second addendum sets out the provider's investment obligations for the 2026–2028 period.

Under the terms of the second amendment, the guaranteed minimum investment in French and European audiovisual and cinematographic works has been increased from €40 million to €90 million per year. Should Amazon make available at least one cinematographic work on its service within twelve months of its theatrical release, this amount may increase to €110 million per year.  To that end, Amazon must conclude an agreement with the representative organizations of the film industry by the end of July 2026. Failing such agreement, the addendum will be automatically terminated on 31 July 2026.

Authored by Anaïs Le Coq and Margaux Ternisien.

France – Amendments to the general regulation of the French Autorité des Marchés Financiers (AMF)

Pursuant to order dated 11 May 2026, Book II of the General Regulation of the AMF has been amended regarding the procedures for submitting information (particularly concerning governance and compliance with gender balance rules) contained in the corporate governance report of certain listed companies. Such information must be submitted electronically to the AMF within thirty days following the annual general meeting, in a format specified in an AMF instruction.

Pursuant to order dated 11 May 2026, Book II of the General Regulation of the AMF has been amended regarding the procedures for submitting information (particularly concerning governance and compliance with gender balance rules) contained in the corporate governance report of certain listed companies. Such information must be submitted electronically to the AMF within thirty days following the annual general meeting, in a format specified in an AMF instruction.

France – Crypto assets

Decree n°2026-420 of 29 May 2026, issued pursuant to the legislative provisions governing crypto-assets, sets forth the rules and procedures applicable to the transfer of ownership of crypto-assets, as well as the procedures for the pledging of crypto-assets.

In particular, it clarifies that a transfer of ownership of crypto-assets occurs at the moment the entry becomes irreversible in the relevant distributed ledger technology, in accordance with its consensus mechanism, it specifies the mandatory information to be included in the statement of pledge of digital assets and in the formal notice in the event of enforcement and it sets forth the required characteristics of the smart contract.

Authored by Charlotte Bonsch.

France – Adoption at First Reading by the French National Assembly of the Emergency Bill on Agricultural Protection and Sovereignty

On 2 June 2026, the French National Assembly adopted at first reading the Emergency Bill on Agricultural Protection and Sovereignty (the “Bill”). Some of the provisions in the Bill aim to strengthen the framework governing agricultural sales contracts, as well as single agreements between suppliers and distributors.

The legislature’s objective in adopting these provisions is twofold: the Bill seeks both to strengthen farmers’ position in the economic chain and improve their income, and to combat abuses by large retailers by prohibiting a number of practices that weaken suppliers’ bargaining power in commercial negotiations.

With regard to the framework governing the conclusion of agricultural sales contracts, the following provisions of the Bill should be noted:

• Time limit for conclusion. The Bill provides for a maximum period of four months for the conclusion of a contract or framework agreement for the sale of agricultural produce. This period runs from the date of receipt by the potential buyer of the proposed contract or framework agreement (Article 19 point 6 of the Bill).
• Price floor. The Bill requires that the contract or framework agreement for the sale of agricultural produce establish a floor price below which the price may not be modified, notwithstanding the automatic price revision mechanisms provided for in the contract or framework agreement (Article 19 point 16 of the Bill).
• Prohibited clauses. The Bill establishes a prohibition on de facto exclusivity clauses in proposed contracts or written framework agreements (Article 19, point 22 of the Bill), as well as clauses whose purpose or effect is an automatic renegotiation or modification of the price in order to align it with a more favourable price applied by a buyer or a competing producer (Article 19 point 35 of the Bill).
• Sharing of export value. Where the contract or framework agreement concerns agricultural raw materials intended to be processed for the purpose of marketing agricultural or food products outside French territory, the contract or framework agreement must include a clause relating to the sharing of the value created at export. This clause shall set out the arrangements for redistribution to producers, based on price or value indicators for products sold on export markets (Article 19 bis A of the Bill).

With regard to the framework governing the contractualisation of commercial relationships between suppliers and distributors, the following provisions of the Bill may be noted:

• Price adjustments based on the cost of agricultural raw materials. The Bill authorises suppliers to include in their general terms and conditions of sale a formula for the automatic adjustment of unit prices based on variations, both upward and downward, in the cost of agricultural raw materials used in the composition of the food product or of the product intended for pet food. The clause shall identify the agricultural raw materials concerned, their geographical origin, and their share in terms of value and volume (Article 19 bis points 4 to 10 of the Bill).
• Reason for a significant reduction in orders. The Bill introduces a new obligation for a distributor making a significant reduction in the level of its orders from a supplier between receipt of the supplier’s general terms and conditions of sale and the renewal of their single agreement. Such a reduction must therefore be subject to prior written notification, setting out the objective elements justifying it and their independence from ongoing commercial negotiations (Article 19 bis point 13 of the Bill).
• Prohibition of Abusive Competitive Tendering Procedures. The Bill establishes a new restrictive competition practice, which may give rise to liability on the part of the person engaging in the practice, consisting in the imposition on a business partner of repeated competitive tendering procedures or calls for bids, where the frequency or terms of such procedures are intended or have the effect of keeping the said partner in a state of economic and social vulnerability or of frustrating the provisions relating to written notice taking into account the duration of the business relationship (Article 19 bis point 18 of the Bill).
• Prohibition of Abusive Reductions in Orders or Deliveries. The Bill establishes an additional restrictive competition practice, which may engage the liability of the buyer or supplier in the event of a significant reduction, in breach of the obligation of good faith in commercial negotiations, in the level of orders placed with a supplier or the level of deliveries made to a buyer between the receipt of the general terms and conditions of sale and the renewal of the single agreement, without having justified in writing the reasons for such a decrease or their independence from the ongoing commercial negotiations (Article 19 bis point 20 of the Bill).

The Bill is still scheduled to be reviewed by the Senate Committee on Economic Affairs.

Authored by Floriane Cadio de Kermainguy and Lise Guillard.

France - Adoption of the New Law on Simplifying Economic Life

Law on Simplifying Economic Life was published in the Official Journal on May 27 (Law No. 2026-403, May 26, 2026, on the Simplification of Economic Life), after the Constitutional Council ruled that it was partially unconstitutional (CC, Dec. No. 2026-903 DC, May 21, 2026).

With regard to corporate law provisions, the Constitutional Council struck down, in particular, Article 23 of the referred bill, which sought to extend to limited liability companies the option of holding general meetings of shareholders and meetings of decision-making bodies via electronic means. According to the court, “Introduced during the first reading, these provisions have no connection, even indirect, with those of Article 7 of the original bill amending the mandatory information to be included on pay stubs and the procedures for providing them to employees

The text introduces the following changes:

Hamon” mechanism (Art. 22)

1‑month period: the text reduce to 1 month instead of 2 previously the timeframe allowing employees to submit an offer in the event of the sale of shares, stock or securities granting access to a majority stake in companies not required to set up a Works Council (CSE), and in the event of the sale of a business (fonds de commerce) in companies not required to set up a CSE. 

- Reduction of the civil fine: The maximum amount of the civil fine is reduced from 2% of the sale price to 0.5%.

These two changes will apply to sales concluded as from 27 July.

Notification thresholds before the Competition Authority (Art. 24)

In order to “reduce the constraints weighing on business growth,” these thresholds are raised respectively from €150 million to €250 million and from €50 million to €80 million (Commercial Code, Art. L. 430‑2, I), and from €75 million to €100 million and from €15 million to €20 million (Commercial Code, Art. L. 430‑2, II).

These changes will enter into force on 1 September and will apply to merger transactions notified to the Competition Authority as from that date.

Removal of imprisonment penalties for certain corporate law offences (Art. 26)

- Amendment of the offence relating to the declaration of beneficial owners

Commercial Code, Art. L. 574‑5: The text removes the 6‑month prison sentence. It also replaces the €7,500 fine with a €250,000 fine (which may be multiplied by five for legal entities, as is the case for all fines – Criminal Code, Art. 131‑38). 

- Failure to submit corporate accounts (annual accounts and management report) to shareholders in public limited companies (SA) (Commercial Code, Art. L. 242‑10) 

- Failure to mention in the annual report presented to shareholders any acquisition of a stake in a company headquartered in France (Commercial Code, Art. L. 247‑1)

These provisions entered into force the day after the text was published in the Official Journal.

Introduction of a “business test” (Arts. 78 to 81)

These articles establish a “Council for Business Simplification,” which will be responsible for assessing the technical, administrative or financial impact of legislative and regulatory texts on businesses. Composed of representatives of companies of all sizes, the council will issue opinions including an impact analysis of the relevant provisions.

Authored by L.-N. Ricard.

France – Publication of a Decree n° 2026-310 on access to the beneficial ownership register and the training obligation for professionals subject to AML/CFT requirements

On 25 April 2026, Decree n° 2026-310 of 24 April 2026 relating to access to the beneficial ownership register and the training obligation applicable to professionals subject to anti-money laundering and counter-terrorist financing requirements was published in the Official Journal.

The Decree introduces Article D. 561-38-1 into the French Monetary and Financial Code, supplementing Articles L. 561-34 and R. 561-38-1 thereof. It provides that training delivered to individuals involved in the implementation of anti-money laundering obligations must be more strictly regulated, including training upon recruitment and on a regular basis thereafter. Such training must enable staff to identify transactions that may be linked to money laundering or terrorist financing. It must cover the obligations set out in Chapters I and II of Title VI of Book V of the French Monetary and Financial Code (i.e., anti-money laundering obligations), as well as the sanctions applicable in the event of non-compliance with those obligations.

The new provision also requires obliged entities to maintain up-to-date records of the training completed by their staff throughout their period of employment and for five years following the end of their duties.

Lastly, this Decree notably amends Section 9 of Chapter I of Title VI of Book V of the French Monetary and Financial Code, relating to the filing of information concerning beneficial owners.

This Decree entered into force on 26 April 2026.

Source: Publication of Decree n° 2026-310 on access to the beneficial ownership register and the training obligation for professionals subject to AML/CFT

European Union – EIOPA – Publication of technical specifications applicable to small and non-complex undertakings and groups

On 7 April 2026, the European Insurance and Occupational Pensions Authority (“EIOPA”) published a document setting out the technical specifications applicable to Small and Non-Complex Undertakings and Small and Non-Complex Groups, following the adoption of Directive 2025/2 of 27 November 2024 amending Directive 2009/138 of 25 November 2009 (“Revised Solvency II”).

Revised Solvency II strengthened the framework for implementing the principle of proportionality, in order to ensure that regulatory requirements are applied in a manner proportionate to the nature, size and complexity of the undertakings and groups concerned. These changes include the creation of a new category of undertakings and groups referred to as small and non-complex.

EIOPA recalls that these entities are identified on the basis of quantitative and qualitative criteria, in accordance with Articles 29a and 213a of Revised Solvency II, which must be met on an ongoing basis over two consecutive financial years.

The purpose of this technical document is to provide operational guidance to undertakings and supervisory authorities in order to facilitate the proper identification of eligible undertakings and groups and the consistent calculation of the applicable risk indicators.

The overall objective is to ensure a harmonised implementation of the new framework across all Member States as from the date of application of Revised Solvency II.

Source: EIOPA published technical specifications applicable to undertakings classified as small and non-complex undertakings and to groups classified as small and non-complex groups

European Union – EIOPA – Public consultation on the treatment of proportional reinsurance treaties containing features that may jeopardise the commensurateness between SCR relief and effective risk transfer

On 15 April 2026, the European Insurance and Occupational Pensions Authority (“EIOPA”) launched a public consultation on the treatment of proportional reinsurance treaties containing features that may jeopardise the commensurateness between the reduction in the Solvency Capital Requirement (“SCR”) generated by the treaty and the effective transfer of risk it provides.

Previously, in July 2021, EIOPA published an Opinion on the use of risk mitigation techniques by insurance undertakings pursuant to Article 29(2) of Regulation n° 1094/2010, providing guidance on the assessment of such techniques, including the consistency between SCR relief and effective risk transfer.

EIOPA is proposing to publish an annex to this Opinion, based on Directive 2009/138 as amended by Directive 2025/2 of 27 November 2024 (“Revised Solvency II”), in particular Articles 134(1), 172(3) and 173 thereof, as well as Commission Delegated Regulation 2015/35, notably Articles 211(2)(b) and (c), 213 and 214.

The purpose of this annex is to provide further clarification regarding the specific case of proportional reinsurance treaties containing mechanisms that may reduce such commensurateness, including sliding-scale commissions, loss corridors and loss limits. EIOPA also reiterates that insurance and reinsurance undertakings remain free to incorporate such mechanisms into their reinsurance arrangements where they are consistent with their risk management policies.

EIOPA further explains that the annex reinforces the interpretation set out in Q&A 1898, submitted to EIOPA on 1 April 2019, according to which any reinsurance commission that constitutes a measure of the cedant’s risk exposure volume is equivalent to premiums and should therefore increase the premium risk calculated under the standard formula. The annex also supplements this Q&A by providing further clarification on the treatment of fixed and variable reinsurance commissions.

Stakeholders may submit their comments until 17 July 2026.

Source: EIOPA launched a public consultation on the treatment of proportional reinsurance treaties containing features that may jeopardise the commensurateness between SCR relief and effective risk transfer

European Union – EIOPA – Public consultation on its proposal to shorten 13 Solvency II guidelines

On 15 April 2026, the European Insurance and Occupational Pensions Authority (“EIOPA”) launched a public consultation aimed at contributing to the objective of regulatory simplification by reducing several guidelines, following the adoption of Directive 2025/2 of 27 November 2024 amending Directive 2009/138 of 25 November 2009 (“Revised Solvency II”).

This public consultation proposes shortening 13 guidelines, notably in relation to Pillars 1 and 2, through both “Type 1” deletions, covering guidelines that are redundant because they merely repeat Level 1 or Level 2 provisions, and “Type 2” deletions, covering guidelines considered to provide limited added value. Following this simplification exercise, national competent authorities will be required to review and update their national frameworks in order to remove the repealed guidelines, while continuing to ensure a level playing field and the application of a single rulebook.

EIOPA emphasises that these amendments are intended solely to clarify and simplify the existing framework and do not reduce supervisory expectations. They do not introduce any new interpretation or application of the existing legal framework.

Stakeholders may submit their comments until 8 July 2026. The revised guidelines will apply from 30 January 2027.

Source: EIOPA launched a public consultation on its proposal to shorten 13 Solvency II guidelines

European Union – EIOPA – Draft technical standards supporting the implementation of the IRRD

On 24 April 2026, the European Insurance and Occupational Pensions Authority (“EIOPA”) submitted to the European Commission two draft technical standards intended to support the implementation of Directive 2025/1 establishing a framework for the recovery and resolution of insurance and reinsurance undertakings (the “IRRD”):

• A draft Regulatory Technical Standard (“RTS”) on the functioning of resolution colleges (EIOPA-BoS-26/129), pursuant to Article 70(7) of the IRRD. The purpose of this draft RTS is to further specify the criteria for the establishment and the practical functioning of resolution colleges, in particular: (i) the operational organisation of resolution colleges; (ii) the arrangements governing joint decisions relating to the development of group resolution plans, resolvability assessments and measures to address impediments to resolvability; and (iii) the governance of cross-border groups resolution.
• A draft Implementing Technical Standard (“ITS”) on procedures and a minimum set of standard forms and templates for the provision of information referred to in Article 12(1) of the IRRD (EIOPA-BoS-26/040). This draft ITS sets out the procedures, forms and standardised templates that insurance undertakings will be required to use when providing resolution authorities with the information necessary for the preparation of resolution plans. Its objective is to strike a balance between the information needs of resolution authorities and the reporting burden placed on insurance undertakings by requiring only information that is strictly necessary.

EIOPA is required to submit these draft technical standards to the European Commission by 29 July 2026 at the latest.

Source: EIOPA submitted to the European Commission two draft technical standards supporting the implementation of the IRRD

European Union – EIOPA – Public consultation on its draft technical advice on minimum common standards for insurance guarantee scheme across the EU

On 5 May 2026, the European Insurance and Occupational Pensions Authority (“EIOPA”) launched a public consultation on its draft technical advice concerning minimum common standards for insurance guarantee schemes (“IGS”) in the European Union, following the request for advice submitted by the European Commission in August 2025 and pursuant to Article 98 of Directive 2025/1 (the “IRRD”).

EIOPA aims to reduce divergences between national regimes in the event of an insurer's failure, enhance policyholder protection and ensure greater consistency between insurance guarantee schemes and the European insurance recovery and resolution framework established under the IRRD.

More specifically, EIOPA intends to examine four key areas: (i) general issues about the impact of insurance guarantee schemes harmonised on a minimum basis, (ii) the operational functioning of IGS, (iii) the conditions required for their effective funding, and (iv) the interaction between the IRRD and harmonised IGS.

EIOPA considers that targeted harmonisation, consistent with the principle of minimum harmonisation, would make it possible to address the most essential aspects of insurance guarantee schemes (scope of coverage, triggering events, funding and coordination) while preserving national flexibility where justified, particularly with regard to institutional structures.

Stakeholders may submit their comments until 26 June 2026.

Source: EIOPA launched a public consultation on its draft technical advice on minimum harmonised insurance guarantee scheme standards in the EU

European Union – AMLA – Publication of several AML/CFT-related documents

The Authority for Anti-Money Laundering and Countering the Financing of Terrorism (“AMLA”) has published several documents relating to anti-money laundering and counter-terrorist financing (“AML/CFT”):

• Two public consultations were launched on 16 April 2026. They concern: (i) draft guidelines under Article 10(4) of Regulation 2024/1624 (the “AMLR”) on business-wide risk assessments, aimed at determining an entity’s risk exposure and ensuring that it has adequate AML/CFT controls in place; and (ii) a draft Regulatory Technical Standard (“RTS”) under Articles 16(4) and 17(3) of the AMLR on group-wide requirements, setting out minimum standards for AML/CFT arrangements at group level, including in cross-border situations and where obliged entities operate in third countries.

  Stakeholders may submit comments until 15 June 2026 for the draft RTS and until 15 July 2026 for the draft guidelines.

• A consultation paper published on 11 May 2026 on a draft Regulatory Technical Standardconcerning cooperation between home and host supervisors and the practical arrangements governing such cooperation, pursuant to Article 46(4) of Directive 2024/1640 (the “AMLD”). The draft RTS notably clarifies the respective responsibilities of home and host supervisors and sets out practical arrangements enabling them to cooperate to the greatest extent possible.
• A publication dated 12 May 2026 concerning reporting requirements intended to provisionally identify entities that may fall under AMLA’s direct supervision, pursuant to the Implementing Technical Standards provided for in Article 15(3) of Regulation 2024/1620 (the “AMLAR”). The publication includes: (i) an interpretative note; and (ii) a template, in tabular format, for identifying eligible entities. Its purpose is to provide reporting instructions for national competent authorities to identify entities meeting the criteria for inclusion in the 2027 selection process for direct supervision.

  Stakeholders may submit comments until 15 August 2026.

• publication dated 13 May 2026 concerning three draft Implementing Technical Standards (“ITS”) aimed at establishing harmonised formats for cooperation between Financial Intelligence Units (“FIU”), AMLA and the European Public Prosecutor’s Office (“EPPO”). AMLA also held a public hearing on these draft standards.

• Draft ITS specifying: (i) the format to be used by FIUs for reporting to the EPPO, pursuant to Article 81(1) of the AMLR; and (ii) the format to be used by AMLA for reporting to the EPPO, pursuant to Article 41(2) of the AMLAR.
• Draft ITS specifying theformat to be used for the exchange of information between FIUs, pursuant to Article 31(2) of the AMLD.

Source: AMLA publications, including two public consultations published on 16 April 2026, a public hearing held on 11 May 2026, publication issued on 12 and another publication on 13 May 2026

Authored by Ghina Farah and Maxime Kaya.

France – Parliamentary committee approves bill establishing a presumption of use of Exploitation of Cultural Content by Artificial Intelligence Providers

On 2 June, the French National Assembly Committee on Cultural Affairs examined the bill establishing a presumption of exploitation of cultural content by artificial intelligence providers. Prior to the committee's review, sixteen amendments had been tabled, primarily seeking to challenge or modify the mechanism previously adopted by the Senate. All of these amendments were rejected, allowing the bill to proceed through the legislative process without any substantial modification at this stage.

Authored by Anaïs Le Coq and Margaux Ternisien.

France – Health research: the CNIL overhauls its reference methodologies

The CNIL has adopted new versions of reference methodologies MR‑001 and MR‑003, together with two common annexes relating to the security and quality of data processing carried out in the context of health research. These texts significantly raise the level of requirements attached to the use of the declaratory regime, against a backdrop of a sharp increase in health data breaches and the widespread use of digital tools in clinical research. These new versions, published in the Official Journal on 23 May 2026, entered into force on 24 May 2026.

The scope of MR‑001 and MR‑003 has been expanded, in particular to cover research conducted abroad by a controller established in France, and joint controllership is expressly taken into account. Stakeholders must therefore review the allocation of roles between the sponsor, healthcare institutions, scientific partners and service providers, in order to ensure consistency between legal basis, internal documentation and contractual provisions. At the same time, the list of data that may be processed has been extended (geographical origin, certain social determinants, sexual orientation, vital status and date of death, etc.), while reiterating that each category must remain scientifically justified and strictly necessary.

The CNIL is tightening its oversight of the internal organisation of projects where the same entities or individuals intervene in several capacities (participant follow‑up, provision of information, administrative tasks). It requires strengthened segregation of duties: physical or logical separation of functions, separate databases or applications and management of access rights strictly on a need‑to‑know basis. As regards information provided to data subjects, the new versions formalise the possibility of electronic delivery and allow, for certain research involving human subjects, information to be given to only one parent, without lowering the expected level of evidence as to the effectiveness, clarity and security of such information.

The two binding annexes form the operational core of the reform. The security annex sets out the measures expected (pseudonymisation using non‑significant codes, rules governing data sharing for proofreading and publication, security of exchanges) and provides for the phased rollout of multi-factor authentication for access to research data: from 1 January 2027 for internet-accessible tools, then from 1 January 2028 for other systems. The quality annex, for its part, in particular regulates the use of remote quality control, recalling the limits placed on access to source documents and the safeguards expected.

The requirements applicable to processors have also been strengthened. Controllers must ensure that sufficient safeguards are in place, carry out or arrange for audits to be carried out, including of investigation sites, and monitor downstream processors, adherence to a code of conduct potentially constituting evidence of such safeguards. As regards transfers outside the European Union, the principles of necessity, data minimisation and compliance with Chapter V of the GDPR are reaffirmed. Previous declarations of compliance remain valid, but require a reassessment of practices, data governance, access schemes and contracts in light of this new level of requirements.

A more detailed article on this topic is available online; you can access it by clicking on this link.

France – Law on the simplification of economic life: long‑awaited and encouraging developments for clinical research in France

Law No. 2026‑403 of 26 May2026 on the simplification of economic life aims to enhance France's attractiveness for clinical research by easing certain administrative constraints and adapting the legal framework to new research models. It forms part of a context of increased competition between European States and responds to recurring criticism from the pharmaceutical and medical device industries regarding the burdensome nature of French procedures.

A first set of measures concerns the flows of human biological material. The law introduces a one‑stop shop enabling sponsors to import and export blood, organs, tissues, cells and derivatives where such flows are directly linked to research authorised by the ANSM, thereby abolishing the previous double authorisation procedure before the ANSM and the Ministry in charge of research. It also extends the scope of declarations relating to the storage of human biological samples to cover import and export activities carried out by entities that have already made such declarations, thus avoiding the need to submit an additional authorisation for the same projects.

A second strand relates to the recognition of decentralised clinical trials and the creation of “research territories”. The law allows certain activities to be carried out at participants' homes or in suitable local facilities, and provides for the possibility for several stakeholders to come together under a common contractual framework to coordinate research activities. These provisions give legal recognition to practices that are already widespread (decentralised or hybrid models) and are presented as a lever to improve participant recruitment, reduce the burden of travel and promote access to trials, including in less well‑served areas.

The reform also strengthens the role of hospital pharmacies (pharmacies à usage intérieur). Subject to certain conditions, they may supply investigational medicinal products to non‑commercial research sites and ensure the dispensing of medicines at participants' homes where this is provided for in the protocol. This development is intended to secure supply and dispensing circuits while offering greater organisational flexibility, which is particularly relevant for trials using telemedicine or involving participants located far from investigation sites.

Lastly, the law amends the framework applicable to health data used for research, study or evaluation purposes. It assigns a central role to the referentials adopted by the data protection authority, with the use of an authorisation regime tending to become an exception. It paves the way for more broadly regulated re‑use of data already collected in the context of care or previous studies, favouring, in certain scenarios, a regime based on information provided to data subjects and their right to object rather than on the collection of fresh consent. These adjustments are particularly well‑suited to real‑world evidence studies, registries and retrospective studies, but their impact will depend on the implementing measures and on the practice of the competent authorities.

A more detailed article on this topic is available online; you can access it by clicking on this link.

Authored by Joséphine Pour and Gauthier Zimmer.