12 Convention on Biological Diversity:
access to genetic resources and benefit-sharing
| (25243)
5155/04
COM(03) 821
+ ADD 1
| Commission Communication and Staff Working Paper: Implementation by the EC of the 'Bonn Guidelines' on access to genetic resources and benefit-sharing under the Convention on Biological Diversity
|
| Legal base | — |
| Document originated | 23 December 2003
|
| Deposited in Parliament | 13 January 2004
|
| Department | Environment, Food and Rural Affairs
|
| Basis of consideration | EM of 26 February 2004
|
| Previous Committee Report | None
|
| To be discussed in Council | No date set
|
| Committee's assessment | Politically important
|
| Committee's decision | Cleared
|
Background
12.1 According to the Commission, genetic resources are of fundamental
importance for many areas of scientific research, both in agriculture
and in an increasing number of industrial sectors. At the same
time, however, the cost of conservation falls most heavily on
countries which are rich in biodiversity, but which are often
poor economically. It is therefore a central tenet of the Convention
on Biological Diversity (CBD) that the benefits arising from the
use of genetic resources should be shared equitably between users
and providers under what is known as Access and Benefit Sharing
(ABS), and, in April 2002, the CBD adopted the so-called "Bonn
Guidelines". Whilst voluntary, these are designed to assist
parties to the Convention to establish the necessary legislative,
administrative and policy measures, and to give guidance on bilateral
arrangements for the transfer of material. The Commission believes
that it would be right for the Community, as both a user and provider
of genetic resources, to implement the Guidelines as a matter
of equity, and in order to encourage others to do the same.
The current document
12.2 It has therefore sought in this Communication (and annexed
Commission Staff Working Paper) to set out the wider background[26]
to the adoption of the Guidelines, as well as the experience of
the operation of ABS under a range of Community legislative and
other matters. However, and most importantly, it also sets out
ways in which the Community might implement the Guidelines, bearing
in mind the extent to which awareness of their provisions varies
from one user group to another. In particular, it highlights
the requirement in the Guidelines for users to seek prior informed
consent (PIC) for access to genetic resources; to respect the
terms and conditions under which those resources were acquired;
to keep documentary evidence of PIC, and of the origin and use
of (and benefits arising from) genetic resources; and to ensure
the fair and equitable sharing of any benefits in conformity with
mutually agreed terms, as set out in a so-called Material Transfer
Agreement (MTA).
12.3 The Communication also highlights the emphasis
placed in the guidelines on the obligations of those Parties to
the Convention which have users within their jurisdiction. These
include:
- informing users of their obligations,
which the Commission considers should be pursued by establishing
a European network of ABS focal points, which would also provide
information to applicants for access to genetic resources;
- encouraging the disclosure of the country of
origin in applications for intellectual property rights;
- co-operation between Parties to the Convention
in addressing infringement of ABS agreements;
- the development of voluntary certification schemes
for organisations abiding by ABS rules; and
- discouraging unfair trade practices.
12.4 However, the most contentious aspect of the
Communication is the measures which might be taken to prevent
the use of genetic resources obtained without prior informed consent.
The Commission notes that, although Community intellectual property
law already contains disclosure provisions in certain circumstances,[27]
these would not require disclosure of the country of origin in
all cases. It therefore explores others ways in which such disclosure
might be introduced in order to under-pin the CBD.
12.5 It notes that the Community has agreed to examine
within the TRIPS Council of the WTO the introduction of a self-standing
disclosure requirement which would allow members to keep track
at a global level of all patent applications relating to genetic
applications for which they have granted access, but it adds that,
whilst a multilateral solution of this kind would create a level
playing field, it would take a long time to be developed. The
Commission therefore believes that consideration should be given
to the Community adopting unilaterally a self-standing obligation,
similar to that envisaged under TRIPS, on patent applicants to
disclose the origin of known genetic resources (or, where the
country of origin is not known, to indicate from whom they were
obtained). At the same time, the Commission stresses that such
a requirement would not become an additional requirement for patentability,
and that any legal consequences arising if it is not respected
would lie in the realms of civil or administrative, rather than
patent, law. However, it also suggests that the Community should
explore the possibility of introducing in the relevant international
fora this same disclosure requirement, not as a self-standing
obligation, but as a formal condition for patentability,[28]
and that in addition patent offices receiving a declaration disclosing
the origin of genetic resources could notify this to the clearing
house mechanism set up under the CBD, thus making it available
to all parties and to the general public.
12.6 The Communication also examines the possibility
of using a certificate of origin to prevent the use of genetic
resources without PIC. It envisages such a certificate accompanying
a genetic resource from its collection phase until the final product
is marketed, and of patent applicants who make use of the resource
in question being required to present it. However, the Commission
also points out that the CBD recognises the need to examine further
the feasibility of such an approach, given the wide variety of
access laws in the different parties, and the fact that there
is at present no single document which they could all use to provide
evidence of PIC. It therefore suggests that the immediate need
is to explore further within the CBD the development of a certificate
of origin, perhaps in the form of a standard MTA.
The Government's view
12.7 In his Explanatory Memorandum of 26 February
2004, the Minister of State (Environment and Agri-Environment)
at the Department for Environment, Food and Rural Affairs (Mr
Elliot Morley) describes the Communication as an autonomous action
by the Commission, which is not related to any commitment to either
the Council or the European Parliament, but which nevertheless
provides a useful resumé
both of the current situation within the Community, and of the
Commission's thinking on possible future policy development.
He comments that, for the most part, the Communication provides
an objective narrative of current experience, although this is
limited since the Bonn Guidelines were adopted less than two years
ago. However, he also comments on the suggestion set out above
that the Community should consider the possible unilateral adoption
of a self-standing obligation for patent applicants to disclose
the origin of genetic resources, as well as the possibility of
a disclosure requirement being required internationally as a formal
condition of patentability. He says that the former is not inconsistent
with Community pronouncements in the TRIPS Council (which were,
however, made on the assumption of a global agreement to that
effect), but he describes the latter suggestion as going well
beyond agreed Community policy and as having difficult repercussions
for UK patent law. Consequently, he considers that any Commission
proposal along such lines would need careful consideration by
the Council and the European Parliament.
Conclusion
12.8 Although this Communication for the most
part simply provides a description of current developments in
this area, it is clear from the Minister's Explanatory Memorandum
that certain aspects of the Commission's thinking, particularly
as regards ways of preventing the use of genetic resources without
prior informed consent, could create problems were they to be
adopted. We therefore think it right to draw the document to
the attention of the House.
12.9 We have also considered carefully whether
it would be sensible, in view of the Minister's comments, to recommend
that the document be debated. However, since the suggestions
in the document are no more than ideas floated by the Commission
in order to stimulate discussion, and would require a further
proposal if they were to be put into effect, we have on balance
concluded that a debate is not necessary at this stage. We are
therefore clearing the document.
26 This includes measures taken under the FAO, the
World Intellectual Property Organisation (WIPO) and the World
Trade Organisation (WTO), with particular reference to the Trade-related
Intellectual Property Rights Agreement (TRIPS), and following
the World Summit on Sustainable Development (WSSD). Back
27
These include the so-called enabling disclosure under Directive
98/44/EC on the legal protection of biotechnological inventions,
and requirements under the European Patent Convention dealing
with background art and the identification of the true inventor. Back
28
In that event, the Commission says that a patent application would
not be processed until the required declaration had been provided,
and that a patent would be revoked if it had been based on a fraudulent
declaration. Back
|
