Compulsory licensing for crisis management and amending Regulation (EC) 816/2006

Wording as published by the EP, in English.

1. Amendment 100Rejected

   Recital 3

   Tabled by Helmut Scholz, Bernd Lange · INTA

   (3) The possibility of using compulsory licences Removed: in situations of national emergency or other circumstances of extreme urgency is explicitly envisaged under the Agreement on Trade-Related Aspects of Intellectual Property Rights (‘TRIPS Removed: Agreement’)3 . Added: Agreement’)3. The Doha Declaration on the TRIPS Agreement states that each WTO Member has not only the right to grant compulsory licences, but also the freedom to determine the grounds upon which such licences are granted. The TRIPS Agreement, in Article 31bis, specifically allows for the export of products made with a compulsory license. Over the past two decades, a compulsory license for export has only been used once worldwide. 3 OJ L 336, 23.12.1994, p. 214

2. Amendment 101Rejected

   Recital 28

   Tabled by Helmut Scholz, Bernd Lange · INTA

   (28) Removed: It is imperative that Added: Notwithstanding the flexibilities included in the TRIPS Agreement, products manufactured under a Union compulsory licence Removed: reach only Added: should be predominantly destined for the supply of the internal market. The Union compulsory licence should therefore Removed: impose clear conditions upon the licensee Added: define clear conditions for the licensee as well as the rights-holder as regards the activities authorised under the licence, Removed: including the territorial reach of those activities. The rights-holder should be able to challenge actions and uses of the rights concerned by the Union compulsory licence that do not comply with the conditions of the licence, as infringement of its intellectual property rights in accordance with Added: which do not exceed those agreed under TRIPS. Directive 2004/48/EC of the European Parliament and of the Removed: Council9 . In order to facilitate monitoring of the distribution of Added: Council9should not impede the legitimate production and supply of pharmaceutical products manufactured under a Removed: Union compulsory licence, including controls by customs authorities, the licensee should ensure that such products have special characteristics that make them easily identifiable and distinguishable from the products marketed by the rights-holder. Added: compulsory licence as provided by law. 9 Directive 2004/48/EC of the European Parliament and of the Council of …

3. Amendment 102Rejected

   Recital 29

   Tabled by Helmut Scholz, Bernd Lange · INTA

   (29) A Union compulsory licence Removed: in the context of a Union crisis or emergency mechanism should only Added: under this Regulation should be granted to Added: predominantly supply the internal market with Removed: crisis-relevant products. Therefore, it should be prohibited to export products manufactured under a Union compulsory licence. Added: relevant products. A Union compulsory licence granted exclusively for export should be permitted under the conditions established in Regulation (EC) No 816/2006.

4. Amendment 103Rejected

   Recital 30

   Tabled by Helmut Scholz, Bernd Lange · INTA

   (30) Customs authorities should Removed: ensure, through a risk analysis approach, Added: ensure that products manufactured under a Union compulsory license are not Removed: exported. Added: exported, except when allowed by relevant Union legislation or the flexibilities envisaged in the TRIPS Agreement. To identify such products, the Removed: main source of information to feed such customs risk-analysis should be Added: custom authorities should take into account the Union compulsory Removed: license itself. Added: license. Information on each implementing act granting or modifying a Union compulsory license … System (CRMS) referred to in Article 36 of Commission Implementing Regulation (EU) Removed: 2015/244710 . Added: 2015/244710. When customs authorities identify a product that is suspected not to comply with the export Removed: prohibition, they should suspend the export of that product and Added: restriction, they should notify the Commission immediately. The Commission should reach a conclusion on the compliance with the export Removed: prohibition Added: restriction within 10 working days, but should have the possibility of requiring the customs authorities to maintain the suspension where necessary. To help its Removed: assessment the Commission may Added: assessment, the Commission should be able to consult the relevant Removed: rights-holder. Added: rights-holder and other relevant stakeholders. Where the Commission concludes that a product does not comply with the export Removed: prohibition, Added: restriction, customs authorities should refuse its export. 10 Commission Implementing Regulation (EU) 2015/2447 …

5. Amendment 104Rejected

   Article 11

   Tabled by Helmut Scholz, Bernd Lange · INTA

   Removed: Prohibition of export The export of Added: Destined use of products 1. The products manufactured under a Union compulsory licence Removed: is prohibited. Added: shall be destined predominantly for the supply of the internal market, except for products exclusively destined for export under Regulation 816/2006. 2. The Commission shall, by means of an implementing act, set out the conditions under which a non-predominant part of the products manufactured under a Union compulsory licence may be exported to third countries. The implementing act shall be adopted in accordance with the advisory procedure referred to in Article 24(2) and enter into force at the same time as the implementing act granting the Union compulsory licence, referred to in Article 7(7).

6. Amendment 105Rejected

   Article 12 – paragraph 3

   Tabled by Helmut Scholz, Bernd Lange · INTA

   3. Where customs authorities identify a product that may fall under Removed: the prohibition Added: restrictions laid down in Article 11, they shall Removed: suspend its export. Customs authorities shall immediately notify the Commission Removed: of the suspension and provide it with all relevant information to enable Removed: it Added: the Commission to establish whether the product was manufactured under a Union compulsory license. Removed: To assess whether the suspended products correspond to the Union compulsory license, Added: Before taking a decision to suspend the export, the Commission may consult the relevant Removed: rights-holder. Added: rights-holder and other relevant stakeholders.

7. Amendment 106Rejected

   Article 12 – paragraph 5

   Tabled by Helmut Scholz, Bernd Lange · INTA

   … product manufactured under a Union compulsory licence does not comply with the Removed: prohibition Added: restrictions laid down in Article 11, customs authorities shall not authorise its release …

8. Amendment 107Rejected

   Article 12 – paragraph 6 – introductory part

   Tabled by Helmut Scholz, Bernd Lange · INTA

   6. Where the Removed: release for export of a product has not been authorised: Added: Commission concludes that a product manufactured under a Union compulsory license does not comply with the restrictions laid down in Article 11:

9. Amendment 108Rejected

   Article 12 – paragraph 6 – point a

   Tabled by Helmut Scholz, Bernd Lange · INTA

   (a) where Removed: appropriate in view of the crisis or emergency context, Added: appropriate, the Commission may Removed: require customs authorities to oblige Added: request the exporter to take specific actions at their own costs, including supplying …