Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional File:**

**2018/0161(COD)**

**'I/A' ITEM NOTE**

From: General Secretariat of the Council

**Brussels, 7 May 2019**
**(OR. en)**

**8734/19**
**ADD 1 REV 1**

**CODEC 989**
**PI 74**
**COMPET 358**
**PHARM 22**
**IA 139**

To: Permanent Representatives Committee/Council

Subject: Draft REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL amending Regulation (EC) No 469/2009 concerning the
supplementary protection certificate for medicinal products **(first reading)**

           - Adoption of the legislative act

          - Statements

**Statement by Denmark**

The European Commission presented on 28 May 2018 the Proposal for a Regulation amending

Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal

products.

Since the beginning of the negotiations, Denmark has focused on maintaining a balanced approach,

where the interests of one industry are not emphasised at the cost of another. Unfortunately,

Denmark does not believe that this has been achieved.

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The purpose of the proposal is to increase the competitiveness of EU-established generic and

biosimilar producers in third countries and not to lower the standards of intellectual property

protection in the EU. In principle, Denmark believes that a re-balance of the competitiveness level

playing field for the EU-established generic and biosimilar pharmaceutical industry versus the non

EU-established generic and biosimilar pharmaceutical industry should be achieved without

undermining the strong competitive position of the EU established innovative pharmaceutical

industry.

While reflecting a compromise, the final text of the regulation presents wide implications that may

potentially benefit one side of the pharmaceutical industry in the future but may generate significant

damage today for the other. By allowing storing of medicinal products and affecting acquired rights

of the SPC holders, Denmark believes that the result is disproportionate and goes far beyond what is

necessary in order to achieve with the objective of the proposal.

The absence of meaningful safeguards for storing will undermine legal certainty for the generic,

biosimilar and innovative industry. It will also further deteriorate market conditions for investments

in research and innovation, which are, by far, higher than any benefit that the SPC waiver proposal

can generate.

Therefore, Denmark cannot support the regulation.

We expect the EU Commission to monitor closely the implementation of this legislation and will

encourage it to take the appropriate measures in order to ensure legal certainty and to protect

Europe’s attractiveness as a hub for innovation and manufacturing.

**Statement by Czechia**

Czechia recognizes the need to keep a balance between the imperative to ensure the attractiveness

of Europe for innovative pharmaceutical companies and the urgency to allow EU based generics

and biosimilars to compete on the global markets.

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Nevertheless, we are concerned about the consequences of the proposed limitation of the rights of

SPC holders. Any such weakening of intellectual property rights in Europe might undermine

investment in research and development of new medicinal products. As a result, Europe might lose

its attractiveness as a center of research and development, which might have a negative impact in

particular on EU patients who are dependent on the supply of innovative medicinal products.

Against this background, we are of the view that any restriction of exclusive rights of SPC holders

should only be permissible in exceptional circumstances such as humanitarian reasons addressing

public health problems in developing countries. Consequently, the geographical scope of export

countries should be more proportionate and limited only to those that are least developed and other

developing countries.

**Joint statement by Belgium, France, Ireland, Portugal, Spain and the Netherlands**

The undersigned Member States can support the political compromise regarding this regulation that

provides carefully crafted exceptions to the supplementary protection certificate within the remit of

intellectual property. We insist that future legislative initiatives also include incentives to promote

research and development and that these initiatives should aim at strengthening the necessary

conditions in the European Union that allow for the enhancement of intellectual property rights and

innovation by the pharmaceutical sector.

**Statement by Malta**

Malta reiterates the same position conveyed during the Competitiveness Council of 18 February

2019 and the COREPER I meeting of 20 February 2019, that it is against the introduction of

stockpiling within the Export Waiver dossier. Furthermore, Malta is not satisfied with the necessary

safeguards placed in the text.

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