WRITTEN QUESTION E-1915/01 by Salvador Garriga Polledo (PPE-DE) to the Commission. Reform of price-fixing policy for pharmaceuticals.
Date: 2001-06-28
Institutions: European Parliament, Provisional data
Subjects: fixing of prices, health policy, intellectual property, market stabilisation, pharmaceutical industry, pharmaceutical product, prices policy

4.7.2002

EN

Official Journal of the European Communities

C 160 E/5

Will the Commission say what the findings and the figures are in this respect in the other Member States,
and whether the level of tax evasion affects the VAT base and, consequently, the level of the Union’s own
resources?

Answer given by Mr Bolkestein on behalf of the Commission

(24 September 2001)

The Commission is aware of several national studies on VAT fraud. However, these studies are very
approximate and may have sharp diverging results. Since no reliable and comparable methods measuring
the level of fraud are available, the Commission cannot draw firm conclusions in this respect for other
Member States.

VAT fraud can influence the overall financial weight of Member States contributions to the Community’s
budget. Member States’ budget contributions are determined on the basis of the best available information.
Several types of fraud have been detected in the present VAT system, affecting pure domestic trade as well
as intra-community and international trade. Moreover an increasing problem of fraud affecting intra-
community trade and international trade has been identified. The Commission has analysed Member States
VAT receipts and has concluded that, although detected fraud in intra-Community trade accounts for a
considerable loss of receipts in absolute terms, it does not appear to have a tangible impact on VAT
receipts. In this context, the Commission would recall that on 28 January 2000 it submitted to the Council
and the Parliament a report constituting a comprehensive examination of each Member State’s VAT
control system and that it has therefore fulfilled its undertaking (1).

(1) COM(2000) 28 final.

(2002/C 160 E/005)

WRITTEN QUESTION E-1915/01

by Salvador Garriga Polledo (PPE-DE) to the Commission

Subject: Reform of price-fixing policy for pharmaceuticals

(28 June 2001)

Recent developments in the pharmaceuticals sector have pointed up the need for a collective and global
approach to the problem of price-fixing policy for pharmaceutical products, with a view to adapting that
policy to new circumstances and events in the health field at world level.

It is already clear that the international agreements on patents need reforming and that the pharmaceutical
industry must operate a change in attitudes which is more than thirty years overdue.

In view of these developments in the sector and the major impact which a reformed regulation of the
market in pharmaceuticals would have at world level, does the Commission believe it should make a
particular contribution by calling for a global debate and a set of proposals aimed at achieving a fair
balance between the health needs of today’s world and the business practices of the pharmaceutical
industry?

Answer given by Mr Lamy on behalf of the Commission

(12 September 2001)

Universal access to basic health services is extremely important, and achieving that goal in a way which
will make a significant contribution to poverty reduction will require a strong international effort. In the
context of the fight against the three main communicable diseases (human immunodeficiency virus/
acquired immune deficiency syndrome (HIV/AIDS), malaria and tuberculosis), the Commission has called
for global tiered pricing to be applied in order to bring about a significant reduction in the cost of key
pharmaceuticals to sufferers in developing countries. However, the Commission has not called for ‘a
reformed regulation of the market in pharmaceuticals’, nor does it advocate any kind of mandatory price-
fixing.

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 @ 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.