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The Nagoya protocol on access to genetic resources – The important issues behind a big name

On July 4th, the European Parliament will vote on a regulation to implement The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity. Behind the long name lie three issues of great importance.

The first is biodiversity itself. As human impact on the planet increases, biodiversity declines. The World Wildlife Fund notes that the loss of species we are seeing today is estimated to be between 1,000 and 10,000 times higher than the natural extinction rate. These losses matter because they affect ecological sustainability and may erode the livelihoods of those who depend on biodiversity.

That’s where the protocol comes in. Its objective is to ensure fair and equitable sharing of benefits arising from the utilisation of genetic resources. The idea is that this will encourage people to conserve biodiversity, not just because it’s the right thing to do, but because it delivers benefits. How great those benefits are has been the subject of much debate. Issue two is whether it is feasible to use an instrument like the Protocol to encourage this responsible economic activity. That depends on what you think the protocol is trying to achieve. The protocol’s negotiators, over the course of ten years of negotiation, developed a strong sense of the complexity of the issues and that the sustainable exploitation of biodiversity requires space for flexible collaboration as well as the platform of principles provided by the protocol. What we see in the final text strikes a careful balance between competing considerations. The same approach was evident in the Commission’s proposal.

The Parliament has had much less time to absorb these issues. Despite doubts expressed by some potential users of genetic resources, it has taken a more regulatory approach, equating the level of regulation with the provision of legal certainty and introducing a concept of retroactivity which will impact badly on business planning and discourage investment in this area. From the pharmaceutical industry perspective, the proposals represent a significant deterrent to engage in a specialised form of research (for which alternatives exist). Equally controversial (particularly for patient health) are the proposals for sanctions for non-compliance to include withdrawal from the market.

The Parliament is attempting to impose equity through regulation. Everyone agrees that the parties to a transaction should get something from it that reflects their contribution. The question is how do you compare the contribution represented by the existence of genetic resource in a particular location with the investment needed to turn that resource into a product and commercialise it successfully? Get it wrong and you devalue either people’s investment in conservation or the added value delivered by their partners in the European Union.

In the pharmaceutical industry the potential links between a genetic resource and a marketed medicine are almost infinitely diverse. Some are so remote that they are not even within the scope of the protocol. For all of these reasons, a contract-based approach, backed by principles and reasonable levels of transparency, should be preferred over regulation and the introduction of arbitrary checkpoints with no competence in biodiversity issues.

EFPIA Communication Team

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