Biological materials, including genetic resources, are frequently used in the development of new medicines and vaccines. They are obtained from different sources and from different trade channels, and are used in different ways and at different stages of the development cycle. If appropriate national laws are in place, industry may access genetic resources and create benefits that could be shared. As such, the pharmaceutical industry’s activities may be regulated by the international regime. It is critical that the industry’s views on how the proposed International Regime can facilitate access and sharing of benefits are taken into account in devising the Regime.
National laws For the pharmaceutical industry, the best way of achieving the ABS provisions of the Convention is for countries to introduce national laws facilitating access to their genetic resources and for users and providers to reach appropriate mutually agreed terms on how benefits, if any, should be shared. This approach allows national governments the flexibility to determine what guidelines will best serve their national interests and allows users the ability to reach agreements that are appropriate to each particular case.
There has been a great deal of rhetoric to the effect that this approach is not enough. However, there is no evidence that, once fully implemented, this approach will not achieve the Convention’s objectives. Many countries have yet to put in place national ABS laws and, in some cases where they have, they have created conditions that hinder, rather than facilitate, access. This suggests that there is a need to implement, refine and improve national laws, not that the national law approach is inadequate to achieve the Convention’s objectives.
Despite patchy national implementation and the industry’s continued support for national laws and mutually agreed terms, the R&D-based industry acknowledges the CBD’s mandate to “elaborate and negotiate an international regime on access and benefit-sharing”. By engaging in the process aimed at developing the Regime, we recognise the fundamental principle that, as the Ad Hoc Working Group’s mandate makes clear, the Regime is intended to “effectively implement” Articles 15 and 8(j) of the CBD and its three objectives.
To this end, the regime must respect and reflect — not rewrite or contradict — the underlying tenets of the CBD and the guidance already set out in the Bonn Guidelines. These include the principle of national sovereignty over genetic resources, the obligation to create conditions which facilitate access on the basis of prior informed consent and the obligation to ensure fair and equitable benefit sharing on mutually agreed terms. The ABS Working Group must also ensure that a full evidence-based gap analysis is carried out as an integral part of devising the regime. If any problems that might arise from the existing CBD scheme and the way it has (or has not) been implemented are not clearly identified, no international regime can hope to solve them.
The proposed regime can best respect the principle of sovereignty by ensuring flexibility so as to enable provider countries to put in place laws which suit their particular conditions. It must also facilitate the creation of user-friendly conditions that encourage users to access and develop genetic resources. Fundamental to this approach must be the principle of mutually agreed terms between users and providers.
A wide range of users and uses The regime must be founded on practicality, not theory or rhetoric. While I write today on behalf of the R&D-based pharmaceutical industry, it will be vital for any Regime to take into account a wide range of users. They include agriculture, horticulture, chemicals, cosmetics and the biopharmaceutical industries — and they range from the largest multinationals through SMEs through academic and non-profit organisations.
Each will use genetic resources and materials which are made from them or using them (often loosely and unhelpfully referred to by the general term “derivatives”) in a wide variety of ways. For example, in the pharmaceutical industry, genetic resources and “derivatives” may be used as the starting point to develop active compounds, as elements of vaccines, as inactive parts of a final product or as tools used in the research or production processes which do not end up in the final product.
Given these realities, Parties must consider how the regime can provide flexibility and user friendliness in a way that reflects the principle of sovereignty, facilitated access and benefit sharing on mutually agreed terms?
To guide, not prescribe The fundamental principle must be that the regime should guide, not prescribe or dictate. It should not seek to regulate unless it is clearly demonstrated there is no other way of achieving CBD objectives. Instead, it should seek to assist countries to devise national ABS regimes that best suit their circumstances and will facilitate access and benefit creation. This respects the principle of sovereignty. And it should not seek to regulate how any benefits are to be shared as this would be contrary to the principle that benefit sharing should be on mutually agreed terms. Capacity building in the fields of national laws and benefit sharing agreements could be an important feature of the Regime.
If potential ‘users’ are to be attracted to ‘providers’, the regime will have to display three features. Its scope must be appropriate; its substance must be balanced and it must offer legal and commercial security. It is vital that negotiators bear in mind this ‘3 S’ rule (Scope, Substance and Security) if they wish the regime effectively to promote the CBD objectives.
I list here specific features of the international regime that the pharmaceutical industry regards as important to include (see box, previous page). The R&D-based pharmaceutical industry believes that constructive, evidence-based discussions which bear in mind these points will make it possible to agree a Regime which meets the mandate of the Working Group. We look forward to contributing our expertise to this process.
Essential features of an ABS regime It should confirm the existing COP decision that human genetic resources are outside the scope of the CBD.
It should not seek to regulate the arrangements that providers and users reach relating to derivatives or the benefits they create. It is clear from the CBD and the Terms of Reference of the Working Group, that these are to be subject to mutually agreed, not mandated, terms.
To the extent that any elements of the Regime are to be binding, they should operate prospectively from the time of agreement of the regime and only apply to genetic resources acquired from in situ or ex situ locations after that date.
The Regime should not seek to include or recommend any obligation that patent applicants disclose the source or origin of genetic resources that are in some way used in the invention. Such obligations serve no useful policy purpose and cannot be drafted in such a way as to lead to sufficient business certainty. If discussions about such an obligation are to take place at all, they should take place in WIPO, the institution that has the appropriate technical intellectual property expertise.
Any further discussion of certificates of origin or similar measures must take into account the possible benefits of the proposed measure and the real cost of setting up and operating the measure, both to providers and to users. These discussions must take into account the fact that there are millions of transactions involving genetic resources and “derivatives” every day. Indeed, every purchase of a bunch of flowers or loaf of bread or bottle of wine is a transaction involving one or more genetic resources or “derivative”.
is Director-General,
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
