WRITTEN QUESTION E-1931/01 by Proinsias De Rossa (PSE) to the Commission. TRIPS.
Date: 2001-06-29
Institutions: European Parliament, Provisional data
Subjects: EU policy, TRIPS, World Trade Organisation, biodiversity, developing countries, international agreement, patent

C 160 E/6

Official Journal of the European Communities

EN

4.7.2002

At the same time, the Commission continues to recognise the need to maintain strong protection of
intellectual property rights in the pharmaceutical sector, since, on a long term basis, these rights provide
the necessary incentives for the pharmaceutical
industry to develop new and improved drugs for the
benefit of the world population.

As regards the World Trade Organisation (WTO) Agreement on the Trade-Related Aspects of Intellectual
Property Rights (TRIPs), the Commission’s view is that the Agreement contains the necessary flexibility to
allow WTO Members to set up an intellectual property regime that is supportive of their public health
objectives. In this context, the Community, together with all other WTO Members in the TRIPs Council, is
engaged in discussions aimed at clarifying certain provisions of the TRIPs Agreement. This process should
allow WTO Members to have a clearer view of measures that can be taken under the TRIPs Agreement to
address health problems.

(2002/C 160 E/006)

WRITTEN QUESTION E-1931/01

by Proinsias De Rossa (PSE) to the Commission

(29 June 2001)

Subject: TRIPS

The WTO Council for TRIPS is currently reviewing the provisions of the TRIPS Agreement Article 27.3b,
which govern patentability of life forms. Various WTO members, in particular the developing countries,
have expressed concern about the current provisions’ impact on their food security prospects. In this
respect Kenya, representing the African group in the WTO, has proposed to exclude all life forms (all
living organisms and their parts, and all living processes) from patenting.

Will the Council and Commission undertake all action necessary to ensure that:

1.

life forms (all

all
patentability within TRIPS;

living organisms and their parts, and living processes) will be excluded from

2.

biopiracy will be addressed internationally;

3. TRIPS will recognise farmers’ rights, especially their role as breeders and conservators of agricultural

seeds and technology.

Will the Council and Commission also consider:

1.

2.

the fact that the TRIPS Agreement only recognises formal innovation systems, which is unfair and
distorted, especially in a development perspective;

the fact that the ‘morality’ and ‘ordre public’ clauses in TRIPS 27,2 are very limited 6 they only apply
to commercialisation of patented inventions, not to patentability of the inventions.

Answer given by Mr Lamy on behalf of the Commission

(5 September 2001)

The Commission is of the view that the existing Article 27.3(b) of the Trade-related aspects of intellectual
property rights (TRIPs) Agreement, which deals with patenting of
life forms, expresses a carefully
negotiated balance between countries who are in favour of the patenting of life forms and those who are
not. As a result, the TRIPs Agreement gives World trade organisation (WTO) Members flexibility with
regard to patentability of life forms. WTO Members are not obliged to allow patenting of plants and
animals. They are only obliged to provide patent protection to inventions related to micro-organisms, and
to grant sui generis protection to plant varieties. Today, many countries remain in favour of patenting life
forms, and do not accept a general prohibition on the patenting of living organisms. Therefore, the
Commission is in favour of Article 27.3(b) as it exists today.

4.7.2002

EN

Official Journal of the European Communities

C 160 E/7

The Community’s views on the link between biodiversity related issues and the TRIPs Agreement were
recently communicated to the TRIPs council (http://www.cc.cec:8082/comm/trade/pdf/dc_bdtrips.pdf). In
this Communication, the Community underlines the different objectives of the TRIPs Agreement and the
Convention on Biological Diversity (CBD), and the fact that they do not deal with the same subject matter,
while acknowledging that there is considerable interaction between the rights referred to in the TRIPs
Agreement and the subject matter of the CBD. Furthermore, the Community declares its readiness to
constructively discuss biodiversity-related issues in the relevant fora, including the WTO, CBD, Food and
Agriculture Organisation (FAO) and World Intellectual Property Organisation (WIPO). In particular, the
Community is open to discussing ways to implement TRIPs and the CBD in a mutually supportive manner,
with a view to better recognising traditional knowledge and its assets, preventing abusive patenting of
traditional knowledge and protecting traditional knowledge and farmer’s rights.

In this regard, the Community has been actively involved in the work of the CBD Panel of Experts on
access to genetic resources and sharing of the benefits arising from their use. The outcome of the work of
this Panel provides the basis upon which a CBD Ad hoc Working Group, meeting in Bonn in October
2001, will try to develop guidelines or other approaches in order to address the issue of access to genetic
resources and benefit-sharing, including related traditional knowledge. The Community is ready to play an
active role in the Ad hoc working group in order to contribute to its success. Furthermore, the issue of
in which the
traditional knowledge is also addressed in the CBD Article 8 j) group,
protection of
Community is also involved.

Moreover, the Commission also refers to the Community’s involvement in the negotiation of a revised
International Undertaking on Plant Genetic Resources for Food and Agriculture within FAO (which
addresses, inter alia, facilitated access within a Multilateral System, sharing of benefits, intellectual property
rights and farmers’ rights), and in the new Intergovernmental Committee on Access to Genetic Resources,
Traditional Knowledge and Folklore in the World Intellectual Property Organisation.

It is a fact that the TRIPs Agreement is silent on the issue of ‘informal innovation systems’ or traditional
knowledge. The TRIPs Agreement mainly incorporates intellectual property (IP) rights which have already
been regulated under other international agreements, such as those falling under the auspices of the WIPO.
However, the TRIPs Agreement in no way prevents countries from setting up a national regime for
protection of traditional knowledge. The Community has made clear that it is open to developing country
requests to include the relationship of TRIPs and CBD including the issue of traditional knowledge on the
agenda of a new trade round.

Finally, the Commission does not share the Honourable Member’s view that the morality and ordre public
clauses of Article 27.2 of the TRIPs Agreement are very limited and only apply to the commercialisation of
patented inventions.

Article 27.2 allows WTO Members to exclude otherwise patentable inventions from patentability on
grounds of ordre public or morality, including to protect human, animal or plant life or health or to avoid
serious prejudice to the environment. At the same time Article 27.2 provides that one can only exclude
from patentability products for which commercialisation is also prohibited. The rationale is that it would
be absurd to deny patents to certain inventions (for example certain types of weapons) on morality
grounds, while at the same time allowing their commercialisation.

(2002/C 160 E/007)

WRITTEN QUESTION P-1958/01

by Elspeth Attwooll (ELDR) to the Commission

(3 July 2001)

Subject: GM Field trials

Under Council Directive 90/220/EEC (1), two separate approval procedures are foreseen under Parts B and
C. At the Community level there has been a de facto moratorium on authorisation for the placing on the