Regulation (EU) 2016/793 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2016/793 of the European Parliament and of the Council

of 11 May 2016

to avoid trade diversion into the European Union of certain key medicines

(codification)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 207(2) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Acting in accordance with the ordinary legislative procedure(1),

Whereas:

(1) Council Regulation (EC) No 953/2003(2) has been substantially amended several times(3). In the interests of clarity and rationality, that Regulation should be codified.

(2) Many of the poorest developing countries are in urgent need of access to affordable essential medicines for the treatment of communicable diseases. Those countries are heavily dependent on imports of medicines as local manufacturing is scarce.

(3) Price segmentation between developed country markets and the poorest developing country markets is necessary to ensure that the poorest developing countries are supplied with essential pharmaceutical products at heavily reduced prices. Therefore, those heavily reduced prices cannot be understood as a reference for the price to be paid for the same products in developed country markets.

(4) Legislative and regulatory instruments are in place in most developed countries to prevent the importation, in certain circumstances, of pharmaceutical products, but such instruments risk becoming insufficient where substantial volumes of heavily discounted pharmaceuticals are sold to the poorest developing country markets, and the economic interest in trade diversion into high priced markets therefore may increase significantly.

(5) There is a need to encourage pharmaceutical manufacturers to make pharmaceutical products available at heavily reduced prices in significantly increased volumes by ensuring through this Regulation that such products remain on the poorest developing country markets. Donations of pharmaceutical products and products sold under contracts awarded in response to competitive tenders from national governments or international procurement bodies, or under a partnership agreed between the manufacturer and the government of a country of destination should be able to qualify under this Regulation on equal conditions, bearing in mind that donations do not contribute to the improvement of access to such products on a sustainable basis.

(6) It is necessary to provide for a procedure which identifies the products, countries and diseases covered by this Regulation.

(7) This Regulation serves the purpose of preventing tiered-priced products from being imported into the Union. Exemptions are laid down for certain situations on the strict condition that it is ensured that the final destination of the products in question is one of the countries listed in Annex II.

(8) Manufacturers of tiered-priced products should differentiate the appearance of tiered- priced products to facilitate the task of identifying them.

(9) It will be appropriate to review the lists of the diseases and the countries of destination covered by this Regulation, as well as the formulae used to identify tiered-priced products in the light, inter alia, of the experience gained from its application.

(10) With regard to tiered-priced products contained in travellers' personal luggage for personal use, the same rules as set out in Regulation (EU) No 608/2013 of the European Parliament and of the Council(4) apply.

(11) Where tiered-priced products have been seized under this Regulation, the competent authority should be able, in accordance with national legislation and with a view to ensuring that the intended use is made of the seized products to the full benefit of the countries listed in Annex II, to decide to make them available for humanitarian purposes in those countries. In the absence of such decision, the seized products should be destroyed.

(12) In order to add products to the list of products covered by this Regulation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in order to amend the Annexes to this Regulation. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council,

HAVE ADOPTED THIS REGULATION:

(1)

Position of the European Parliament of 9 March 2016 (not yet published in the Official Journal) and decision of the Council of 11 April 2016.

(2)

Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines (OJ L 135, 3.6.2003, p. 5).

(3)

See Annex VI.

(4)

Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003 (OJ L 181, 29.6.2013, p. 15).