What changed between the draft committee report of 16 Oct 2023 and the draft committee report of 1 Dec 2025

Added:SHORT JUSTIFICATION

Removed:Recital 18: (18) The participation of an advisory body aims at guaranteeing a comprehensive, thorough, and concrete assessment of the situation, taking into consideration the individual merits of each situation. It is therefore important that the advisory body has the right composition, expertise, and procedures to support the Commission when deciding on whether to grant a Union compulsory licence and under what conditions. Union crisis mechanisms usually include the setting-up of an advisory body ensuring coordination of action of the Commission and relevant bodies and agencies, the Council and the Member States. In this respect, an advisory group is set up under SMEI. Regulation (EU) No 2022/2371 provides for a Health Crisis Board and under Regulation (EU) No XXX/XX (Chips Act) [COM/2022) 46], the Commission relies on the Semiconductor Board. Those advisory bodies have the right composition, expertise, and procedures to address the crises and emergencies for which they have been set-up. When compulsory licensing is being discussed in the context of such crisis instrument, relying on the advisory body set-up for the specific instrument allows the Commission to be adequately advised and avoid duplication of advisory bodies, leading to incoherences between processes. The competent advisory bodies should be listed, together with the corresponding crisis mechanisms, in an Annex to this Regulation. The Commission should ensure that representatives of other crisis-relevant bodies at Union lev…

Added:The Council position at first reading reflects the agreement reached between Parliament and the Council in interinstitutional negotiations at early second-reading stage.

Removed:Recital 19: (19) The role of the advisory body is to advise the Commission when discussions arise on the need to rely on compulsory licensing at Union level. It should provide the Commission with a binding opinion. Its main tasks include assisting of the Commission in the determination of the necessity to rely on compulsory licensing at Union level, and in the determination of the conditions for such licensing. When the advisory body is already set up, its existing rules of procedure should apply. As regards ad hoc advisory bodies, they should provide the Commission with information and input concerning the situation on the national level, including information on manufacturing capacities, potential licensees and, if applicable, proposals for voluntary solutions. In addition, the advisory body should have the function of collecting and analysing relevant data, as well as ensuring coherence and cooperation with other crisis relevant bodies at Union and national level in order to ensure an adequate, coordinated and coherent crisis reply at Union level.

Removed:It should be a binding technical expert opinion issued by a body composed of experts from the national offices which already has experience in assessing applications for compulsory licences. In addition, there should be further checks on the Commission's power by the Council and/or the Parliament and procedures should be put in place to review and even suspend the execution of the Commission's decision.

Removed:Recital 20: (20) The Commission should grant the Union compulsory licence in the light of the binding opinion of the advisory body. Persons, in particular the licensee and the rights-holder, whose interests may be affected by the Union compulsory licence should be given the opportunity to submit their comments to the advisory body upon receiving the case file and analyses presented to or conducted by the advisory body, and be provided with any other pertinent information they require for their evaluation of the potential repercussions of a proposed Union compulsory license on their intellectual property rights. These elements should enable the Commission to consider the individual merits of the situation and determine, on that basis, the adequate conditions of the licence, including an adequate remuneration to be paid by the licensee to the rights-holder. To avoid overproduction of products

Removed:To protect their rights, including those outlined in Article 17 (right to property), Article 41 (right of access to the file and right to be heard), and Article 52 of the Charter (proportionality), rights-holders should have access to the file and all pertinent information before they offer feedback on the proposed Union compulsory license. The right of the right holder is limited to being informed and being heard, but not to enter into the procedure, as is the case in national compulsory licensing procedures. There is a lack of defence since the right holder cannot present arguments, which, if necessary, must be answered and justified in the event of rejection.

Removed:Recital 21: (21) The Commission should guarantee that the rights-holder has the right to be heard before the adoption of the Union compulsory licence. Therefore, the Commission should inform the concerned rights-holder individually without undue delay that a Union compulsory licence might be granted. The involvement of the rights-holder should be possible once there are ongoing advanced discussions in the relevant advisory body as regards the granting of a Union compulsory licence.

Removed:The right of the right holder is limited to being informed and being heard, but not to enter into the procedure, as is the case in national compulsory licensing procedures. There is a lack of defence since the right holder cannot present arguments, which, if necessary, must be answered and justified in the event of rejection

Removed:Recital 22: (22) When informed of advanced discussions as regards the granting of a Union compulsory licence, the rights-holder should have the possibility to propose a voluntary agreement, should the circumstances of the Union crisis or emergency, including the urgency of the situation, allow it. The rights-holder should also be given the opportunity to comment on the need for a Union compulsory licence and on the conditions of the licence, including remuneration, should it be granted. To this end, the rights-holder should be allowed to provide the Commission with written or oral comments and any information the rights-holder considers useful to allow the Commission to make a fair, comprehensive, and thorough assessment of the situation. The Commission should allow the rights-holder a reasonable period of time to provide comments and information, considering the situation of the rights-holder and the urgency of the situation. The comments of the rights-holder should be transmitted by the Commission to the competent advisory body. In order for confidential information to be shared with the Commission, the Commission shall ensure a safe environment for the sharing of this information and should take measures to preserve the confidentiality of the documents provided by the rights-holder in the context of that procedure. Once a Union compulsory licence has been granted, the Commission should notify the rights-holder as soon as reasonably practicable.

Removed:Recital 22 a (new): (22a) In order to guarantee the rights of rights-holders and licensees, their comments should in all circumstances be forwarded to the advisory body, including where the Commission considers documents or submissions to be irrelevant. If compulsory licensing is indeed an exceptional mechanism, that is to say only for cases where agreement is not possible or sufficient to resolve a crisis or emergency, prior consultation of the parties should be included as part of the procedure.

Removed:Recital 23: (23) The initiation of any compulsory licensing procedure should first involve the identification of the intellectual property rights concerned, the rights-holders concerned, as well as potential licensees, with the involvement of the national Intellectual Property Offices.

Removed:Recital 24: (24) The Commission should, assisted by the advisory body, identify in its decision the patent, patent application, supplementary protection certificate and utility model related to the crisis-relevant products, and the rights-holders of those intellectual property rights. In certain circumstances, the identification of intellectual property rights and of their respective rights-holders may require lengthy and complex investigations. The Commission should identify all applicable and relevant intellectual property rights and their rights-holder before granting the compulsory licence. The implementing act should identify any necessary safeguards and remuneration to be paid to each identified rights-holder.

Removed:The seriousness of the measure requires, in any case, that it be determined which product is necessary and which patents are involved in its production.

Removed:Recital 25: (25) Where the rights-holder or not all the rights-holders could be identified in a reasonable period of time, the Commission should not grant the Union compulsory licence.

Removed:Coherence with the previous recitals

Removed:Recital 32 a (new): (32a) Where appropriate, the Commission should oblige the rights-holder to disclose the trade secrets which are strictly necessary in order to achieve the purpose of the Union compulsory licence. Indeed, it is possible that the detailed description of how to carry out the invention might not be sufficient and complete enough to enable the licensee to efficiently use that invention. This could encompass, without being exhaustively limited to, the comprehensive transfer of necessary technology, expertise, data, samples, and reference products essential for production and obtaining market authorisation in collaboration with the licensee, taking into account each other's public interests. In cases where that additional information and know-how is necessary, some of which is an undisclosed trade secret, the disclosure of that necessary trade secret, with a view to only achieving the purpose of exercising the Union compulsory licence pursuant to this Regulation, should be considered to be lawful within the meaning of Article 3(2) of Directive (EU) 2016/943 of the European Parliament and the Council. The Commission should require the rights-holders to put in place all appropriate measures, including technical and organisational measures, to ensure the confidentiality of trade secrets, in particular vis-à-vis third parties and the protection of the legitimate interests of all parties. Any use, acquisition or disclosure of trade secrets which would not be necessary to fulfil the objec…

Removed:To facilitate the prompt availability of the generic or alternative version of the medical product within the Union, the rights holder, subject to a compulsory license, should furnish adequate and essential information and in certain cases disclose the trade secrets which are strictly needed to fulfil the objective of the Union compulsory licence. This will guarantee the efficient and timely replication of the medical product protected by the intellectual property mentioned in Article 1 of the regulation. The information should encompass various aspects, including but not restricted to the technical specifications of the product, requisite tests, and other data essential for securing registration and/or market authorization from the competent authorities.

Removed:Recital 32 b (new): (32b) This Regulation should guarantee that the Commission has the authority to compel rights-holders to provide all necessary information to facilitate the rapid and efficient production of critical crisis-related products, such as pharmaceuticals and other health-related items. This information should encompass details about know-how, particularly when it is essential for the effective implementation of compulsory licensing. While patent licensing alone might suffice to enable other manufacturers to quickly produce simple pharmaceuticals, in the case of more intricate pharmaceutical products, such as vaccines during a pandemic, it is often insufficient. In such instances, the alternative producer will also require immediate access to know-how information to effectively utilise compulsory licensing.

Removed:Recital 41 a (new): (41a) Since the objective of this Regulation, namely to ensure access to crisis-relevant patented products needed to address crises in the internal market, cannot be sufficiently achieved by the Member States because of the fragmentation of compulsory licensing in the Union and the insufficient territorial scope of national compulsory licensing but can rather, by reason of the scale and effects of the necessary solution, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

Removed:Article 3 – paragraph 1 – introductory part: For the purposes of this Regulation, the following definitions apply:

Removed:Article 3 – paragraph 1 – point -a (new): (-a) ‘crisis mode or emergency mode’ means a crisis mode or an emergency mode, as applicable, listed in the Annex to this Regulation, which has been activated or declared in the context of a Union crisis or emergency mechanism listed in that Annex in accordance with one of the Union acts listed therein;

Removed:Article 3 – paragraph 1 – point a: (a) ‘crisis-relevant products’ means products or processes that are indispensable for responding to a crisis or emergency or for addressing the impacts of a crisis or emergency in the Union as determined by the Commission through the guidance of the advisory body in accordance with Article 6;

Removed:Article 4 – paragraph 1: The Commission shall not issue a Union compulsory license for any crisis or emergency-related product until the rights holder has been given a fair chance to engage in negotiations for a voluntary agreement with the licensee. The timeframe for reaching a voluntary agreement shall be adequate for discussions with potential partners, considering the urgency of the situation, and shall be a reasonable period of time from the initial notification to the relevant rights holder. / In the event of a failure of a voluntary agreement between the rights-holder and the licensee pursuant to the first subparagraph, the Commission may grant a Union compulsory licence in the event of a crisis mode or an emergency mode.

Removed:In times of crisis, voluntary agreements should be promoted, and the best way to achieve this is by stipulating a reasonable time frame for the rights holder to negotiate a voluntary agreement during a crisis.

Removed:Article 5 – paragraph 1 – introductory part: 1. Where a voluntary agreement cannot be reached between the rights-holder and the licensee pursuant to Article 4 (-1a), the Union compulsory license that may be granted by the Commission in accordance with the first subparagraph of Article 4 shall, notwithstanding the obligations to be fulfilled by the licensee in accordance with Article 10

Removed:(CLs) must maintain proportionality, targeting only the patents essential for addressing the crisis, avoiding excessive breadth that encompasses patents associated with specific products. Additionally, they should be limited to the crisis's immediate requirements, preventing potential market distortions once the CL's scope expires. Furthermore, the license should hold responsibility for the production and distribution of crisis-related products, ensuring accurate product tracking, while also safeguarding the rights holders from undue liability for unrelated business activities over which they have no control, thereby preventing any discouragement from investing in crisis-related products.

Removed:Article 5 – paragraph 1 – point b: (b) have a strict limitation concerning scope, field of application, necessary quantities, and a duration that is closely in line with the specific purpose for which the compulsory licence is issued, as well as strictly linked to the scope and duration of the crisis or emergency mode under which it is granted within the Union.;

Removed:Article 5 – paragraph 1 – point f a (new): (fa) clearly state that the licensee is responsible for any liability or warranties related to the production and distribution of crisis-relevant products, absolving the rights-holder from any claims arising as a result of product liability issues.

Removed:Article 6 – paragraph 2 – point a a (new): (aa) the assessment of whether the obligation to afford the rights-holder an opportunity to engage in negotiations for a voluntary license, as specified in Article 4 (-1a), has been complied with;

Removed:Article 6 – paragraph 2 – point b a (new): (ba) the determination of crisis-relevant products;

Removed:Article 6 – paragraph 4 – point a a (new): (aa) shall guarantee involvement of rights-holders by extending invitations to their representatives for the pertinent advisory body meetings, ensuring that the rights-holders are granted a timely and fair chance to provide comments; and

Removed:Article 6 – paragraph 4 – point b: (b) may invite representatives of the national authorities responsible for issuing compulsory licences under national law, representatives of the European Parliament, representatives of economic operators, potential licensees, stakeholder organisations, social partners and experts to attend meetings of the advisory body as observers.

Removed:Article 6 – paragraph 5: 5. In the absence of any existing competent advisory body, the tasks referred to in paragraph 2 shall be performed by an ad hoc advisory body set up by the Commission (the ‘ad hoc advisory body’). The Commission shall chair the ad hoc advisory body and ensure its secretariat. The ad hoc advisory body shall be composed of representatives of the institutions and bodies of each Member State that exercise the competence to grant national compulsory licences under national law.

Removed:Article 7 – paragraph 2: 2. The opinion of the advisory body shall be binding on the Commission. The Commission may set a time limit for the advisory body to submit its opinion. The time limit shall be reasonable and appropriate to the circumstances of the situation, taking particular account of the urgency of the matter.

Removed:Article 7 – paragraph 3 – introductory part: 3. Before issuing the opinion, the advisory body shall give the rights-holder and the licensee an opportunity to comment on the following:

Removed:Article 7 – paragraph 3 – point a: (a) the possibility to promptly reach a voluntary licensing agreement with manufacturers on intellectual property rights for the purpose of manufacturing, using and distributing the crisis-relevant products;

Removed:Article 7 – paragraph 3 – subparagraph 1 a (new): Before issuing the opinion, the advisory body shall consider: / (a) the rights and interests of the rights-holder and the licensee; / (b) existing national compulsory licences reported to the Commission in accordance with Article 22.

Removed:Moved from Article 7(6).

Removed:Article 7 – paragraph 4: 4. The Commission shall notify the rights-holders and the licensee as soon as possible of the fact that a Union compulsory licence may be granted. The Commission shall notify the rights-holders individually.

Removed:Article 7 – paragraph 6 – introductory part: 6. When assessing whether a Union compulsory licence is to be granted, the Commission shall follow the opinion referred to in paragraph 2. / (deleted) / (deleted) / (deleted)

Removed:Points (b) and (c) moved up to Article 7(3), subparagraph 1a.

Removed:Article 8 – paragraph 1 – point h: (h) measures complementing the compulsory licence, as referred to in Article 13a, including, where relevant, the obligation for the rights-holder to disclose trade secrets to the licensee only to the extent to which it is strictly necessary to achieve the objective of the compulsory licence.

Removed:Article 9 – paragraph 1 a (new): 1a. The rights-holder shall receive the remuneration within a pre-established timeframe as agreed with the Commission.

Removed:Article 9 – paragraph 2: 2. The remuneration shall be determined based on the total gross revenue generated by the licensee from the pertinent activities governed by the Union compulsory licence.

Removed:Article 9 – paragraph 3 – point d a (new): (da) the possible disclosure of trade secrets for the purpose of exercising the Union compulsory licence pursuant to Article 13a(1); that disclosure shall give rise to adequate compensation for the rights-holder.

Removed:Article 10 – paragraph 1 – subparagraph 1 – point c a (new): (ca) a detailed account of the products produced under the Union compulsory licence;

Removed:Article 10 – paragraph 1 – subparagraph 1 – point c b (new): (cb) treat the information acquired in relation to the Union compulsory licence with utmost confidentiality and implement all necessary measures to safeguard such confidential information;

Removed:Article 13 – paragraph 2: 2. In compliance with the good faith obligation, the rights-holder and the licensee shall make their best efforts to fulfil the objective of the Union compulsory licence, taking into account each other's public interests.

Removed:Article 13 a (new): Article 13a / Additional measures complementing the Union compulsory licence / 1. Where necessary , the Commission shall decide, upon a reasoned request by the rights-holder or the licensee, or on its own initiative, on additional measures complementing the Union compulsory licence to ensure it achieves its objective as well as to facilitate and ensure the good collaboration between the rights-holder and the licensee. / 2. Where necessary, the Commission shall request from the rights-holder the disclosure of trade secrets to the licensee in order to provide him with the necessary know-how to strictly achieve the objective of the Union compulsory licence as provided for in this Regulation. In such cases, the Commission shall order all appropriate measures necessary to preserve the confidentiality of trade secrets, in particular in relation to third parties. / 3. Where the Commission considers modifying or adopting additional measures as referred to in paragraphs 1 and 2, it shall consult the advisory body referred to in Article 6. / 4. The implementing acts referred to in paragraphs 1 and 2 shall be adopted in accordance with the rules referred to in Article 7(6), points (a) and (b), and Article 7(7) and (8).

Removed:Paragraphs 1, 3 and 4 moved from article 14.

Removed:Article 14 – paragraph 2: deleted

Removed:Moved up to article 13a new.

Removed:Article 14 – paragraph 4: 4. When the Commission considers terminating the Union compulsory licence, it shall consult the advisory body referred to in Article 6.

Removed:Deletion moved up to article 13a new

Removed:Article 14 – paragraph 6: 6. The implementing acts referred to in paragraph 1 and 3 shall be adopted in accordance with the rules referred to in Article 7(6) (a) and (b), 7(7) and 7(8).

Removed:Deletion moved up to article 13a new.

Removed:Article 15 – paragraph 1 – point c: (c) the rights-holder or the licensee fail to comply with any obligation resulting from the additional measures complementing the Union compulsory licence as referred to in Articles 8(1)(h) and Article 13a(1) and (2), as specified in the relevant implementing act.

Removed:Article 16 – paragraph 1 – point c: (c) the rights-holder or the licensee to comply with any obligation resulting from the additional measures complementing the Union compulsory licence as referred to in Articles 8(1)(h) and Article 13a(1) and (2), as specified in the relevant implementing act.

Removed:Article 19 – paragraph 1: 1. Before adopting a decision pursuant to Article 15 or 16, the Commission shall give the licensee or the rights-holder the opportunity of being heard and fully involved on the alleged infringement which is to be made subject to a fine or periodic penalty payments.