Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems

Any person may submit an application for a compulsory licence under this Regulation to a competent authority in the Member State or States where patents or supplementary protection certificates have effect and cover his intended activities of manufacture and sale for export.

If the person applying for a compulsory licence is submitting applications to authorities in more than one country for the same product, he shall indicate that fact in each application, together with details of the quantities and importing countries concerned.

The application pursuant to paragraph 1 shall set out the following:

Purely formal or administrative requirements necessary for the efficient processing of the application may be prescribed under national law. Such requirements shall not add unnecessarily to the costs or burdens placed upon the applicant and, in any event, shall not render the procedure for granting compulsory licences under this Regulation more burdensome than the procedure for the granting of other compulsory licences under national law.

The competent authority shall verify that:

The competent authority shall verify that the quantity of product cited in the application does not exceed that notified to the WTO by an importing country which is a WTO member, or to the Commission by an importing country which is not a WTO member, and that, taking into account other compulsory licences granted elsewhere, the total amount of product authorised to be produced for any importing country does not significantly exceed the amount notified by that country to the WTO, in the case of importing countries which are WTO members, or to the Commission, in the case of importing countries which are not WTO members.

The applicant shall provide evidence to satisfy the competent authority that he has made efforts to obtain authorisation from the rights-holder and that such efforts have not been successful within a period of thirty days before submitting the application.

The requirement in paragraph 1 shall not apply in situations of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use under Article 31(b) of the TRIPS Agreement.

The licence granted shall be non-assignable, except with that part of the enterprise or goodwill which enjoys the licence, and non-exclusive. It shall contain the specific conditions set out in paragraphs 2 to 9 to be fulfilled by the licensee.

The amount of product(s) manufactured under the licence shall not exceed what is necessary to meet the needs of the importing country or countries cited in the application, taking into account the amount of product(s) manufactured under other compulsory licences granted elsewhere.

The duration of the licence shall be indicated.

The licence shall be strictly limited to all acts necessary for the purpose of manufacturing the product in question for export and distribution in the country or countries cited in the application. No product made or imported under the compulsory licence shall be offered for sale or put on the market in any country other than that cited in the application, except where an importing country avails itself of the possibilities under subparagraph 6(i) of the Decision to export to fellow members of a regional trade agreement that share the health problem in question.

Products made under the licence shall be clearly identified, through specific labelling or marking, as being produced pursuant to this Regulation. The products shall be distinguished from those made by the rights-holder through special packaging and/or special colouring/shaping, provided that such distinction is feasible and does not have a significant impact on price. The packaging and any associated literature shall bear an indication that the product is subject to a compulsory licence under this Regulation, giving the name of the competent authority and any identifying reference number, and specifying clearly that the product is exclusively for export to and distribution in the importing country or countries concerned. Details of the product characteristics shall be made available to the customs authorities of the Member States.

Before shipment to the importing country or countries cited in the application, the licensee shall post on a website the following information:

If the product(s) covered by the compulsory licence are patented in the importing countries cited in the application, the product(s) shall only be exported if those countries have issued a compulsory licence for the import, sale and/or distribution of the products.

The competent authority may at the request of the rights-holder or on its own initiative, if national law allows the competent authority to act on its own initiative, request access to books and records kept by the licensee, for the sole purpose of checking whether the terms of the licence, and in particular those relating to the final destination of the products, have been met. The books and records shall include proof of exportation of the product, through a declaration of exportation certified by the customs authority concerned, and proof of importation from one of the bodies referred to in Article 6(3)(f).

The licensee shall be responsible for the payment of adequate remuneration to the rights-holder as determined by the competent authority as follows:

The licence conditions are without prejudice to the method of distribution in the importing country.

The import into the Community of products manufactured under a compulsory licence granted pursuant to the Decision and/or this Regulation for the purposes of release for free circulation, re-export, placing under suspensive procedures or placing in a free zone or free warehouse shall be prohibited.

Paragraph 1 shall not apply in the case of re-export to the importing country cited in the application and identified in the packaging and documentation associated with the product, or placing under a transit or customs warehouse procedure or in a free zone or free warehouse for the purpose of re-export to that importing country.

If there are sufficient grounds for suspecting that products manufactured under a compulsory licence granted pursuant to the Decision and/or this Regulation are being imported into the Community contrary to Article 13(1), customs authorities shall suspend the release of, or detain, the products concerned for the time necessary to obtain a decision of the competent authority on the character of the merchandise. Member States shall ensure that a body has the authority to review whether such importation is taking place. The period of suspension or detention shall not exceed 10 working days unless special circumstances apply, in which case the period may be extended by a maximum of 10 working days. Upon expiry of that period, the products shall be released, provided that all customs formalities have been complied with.

The competent authority, the rights-holder and the manufacturer or exporter of the products concerned shall be informed without delay of the suspended release or detention of the products and shall be given all information available with respect to the products concerned. Due account shall be taken of national provisions on the protection of personal data and commercial and industrial secrecy and professional and administrative confidentiality.

If it is confirmed that products suspended for release or detained by customs authorities were intended for import into the Community contrary to the prohibition in Article 13(1), the competent authority shall ensure that the products are seized and disposed of in accordance with national legislation.

The procedure of suspension or detention or seizure of the goods shall be carried out at the expense of the importer. If it is not possible to recover those expenses from the importer, they may, in accordance with national legislation, be recovered from any other person responsible for the attempted illicit importation.

If the products suspended for release or detained by customs authorities are subsequently found not to violate the prohibition in Article 13(1), the customs authorities shall release the products to the consignee, provided that all customs formalities have been complied with.

The competent authority shall inform the Commission of any decisions on seizure or destruction adopted pursuant to this Regulation.

Subject to adequate protection of the legitimate interests of the licensee, a compulsory licence granted pursuant to this Regulation may be terminated by a decision of the competent authority or by one of the bodies referred to in Article 17 if the licence conditions are not respected by the licensee.

Termination of a licence granted under this Regulation shall be notified to the Council for TRIPS through the intermediary of the Commission.

Following termination of the licence, the competent authority, or any other body appointed by the Member State, shall be entitled to establish a reasonable period of time within which the licensee shall arrange for any product in his possession, custody, power or control to be redirected at his expense to countries in need as referred to in Article 4 or otherwise disposed of as prescribed by the competent authority, or by another body appointed by the Member State, in consultation with the rights-holder.

When notified by the importing country that the amount of pharmaceutical product has become insufficient to meet its needs, the competent authority may, following an application by the licensee, modify the conditions of the licence permitting the manufacture and export of additional quantities of the product to the extent necessary to meet the needs of the importing country concerned. In such cases the licensee's application shall be processed in accordance with a simplified and accelerated procedure, whereby the information set out in Article 6(3), points (a) and (b), shall not be required provided that the original compulsory licence is identified by the licensee. In situations where Article 9(1) applies but the derogation set out in Article 9(2) does not apply, no further evidence of negotiation with the rights-holder will be required, provided that the additional amount requested does not exceed 25 % of the amount granted under the original licence.

Appeals against any decision of the competent authority, and disputes concerning compliance with the conditions of the licence, shall be heard by the appropriate body responsible under national law.

Member States shall ensure that the competent authority and/or the body referred to in paragraph 1 have the power to rule that an appeal against a decision granting a compulsory licence shall have suspensory effect.

Where the application for a compulsory licence concerns a medicinal product, the applicant may avail himself of:

If a request for any of the above procedures concerns a product which is a generic of a reference medicinal product which is or has been authorised under Article 6 of Directive 2001/83/EC, the protection periods set out in Article 14(11) of Regulation (EC) No 726/2004 and in Articles 10(1) and 10(5) of Directive 2001/83/EC shall not apply.

By way of derogation from Article 1, second subparagraph, from Article 2, point (4), and from Article 3, the Commission may grant a compulsory licence applicable to the whole of the Union where the activities of manufacture and sale for export are spread across different Member States and would therefore require compulsory licences for the same product in more than one Member State.

Any person may submit an application for a Union compulsory licence referred to in paragraph 1 of this Article. By way of derogation from Article 6(1) and (2), that application shall be submitted to the Commission. The application shall fulfil the requirements laid down in Article 6(3), points (a) to (f), and shall specify the Member States in which the activities of manufacture and sale for export of the product to be covered by the Union compulsory licence are to be carried out.

The Union compulsory licence referred to in paragraph 1 of this Article shall be subject to the conditions set out in Article 10 and shall specify that it is applicable to the whole of the Union.

The Commission shall, by means of an implementing act:

The Commission shall be assisted by a committee (the “Compulsory Licensing Committee”). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.