On 12th October, the Nagoya Protocol entered into force, for its 51 Parties, 4 years after its adoption by the Conference of the Parties to the Convention on Biological Diversity (CBD). It provides a framework which, if it is implemented in a practical manner, will promote the access and benefit sharing objective of the CBD. Many EU industries will be profoundly affected by the Protocol, including cosmetics, horticulture, seeds and medicines (both herbal and prescription). Most, if not all, have endorsed the goals of the Protocol, while fully recognizing that for business, the devil will be in the detail of how it is implemented in national laws.
The detail was always going to be difficult. The most stringent obligations from the EU Regulation implementing the Nagoya Protocol will come into force in one year. Users therefore have one year to work out how to comply with the Regulation, whereas the Protocol took 10 years to negotiate. Challenging. The Protocol is applying global principles where national legislation is often lacking or inconsistent and where questions of application have to be considered in the light of decades, if not centuries, of unregulated transactions. At its heart, the Protocol and the Regulation seek to introduce regulation without undermining the economic activities that create value from genetic resources. But there are EU jobs at stake in how the protocol is implemented. And the Protocol and Regulation may have wider consequences, including for public health.
The drafters of the Protocol did a good job in many respects. They did not seek to get countries to compensate each other for past transfers of genetic resources. They recognized that many commodity genetic resources (apples, oranges) are routinely traded every day and that trade should not be affected by the Protocol. At the same time, by focusing on more complex industries, they created new challenges for those charged with implementation.
The EU started well, taking a rational and balanced approach to implementation in its implementing regulation. However, it is now stepping back and leaving a void for want of being able to follow through on its earlier pragmatism. The example of pathogens is the most telling case. Why pathogens such as the Ebola virus are even included under a regulation dedicated to the conservation of biodiversity has never been satisfactorily explained. There is however a real risk that the Regulation will seriously compromise efforts to timely find new medicines and vaccines, particularly in situations where time is of the essence. All stakeholders in and outside the EU should work together to prevent this from happening.
The EU and Member States have many more choices to make in respect of the scope of implementation of its Regulation and should make them right now. This includes, but is far from being limited to the determination of the final stage of development, which will serve as checkpoint or for Member States, and the determination of potential sanctions.
Compliance must be practical and organisations using genetic resources critically need clarity about their obligations. Some of the clarity must be provided by the EU so as to ensure a uniform interpretation and application of the Regulation across the EU, and EFPIA believes there is a need for extensive guidance to users as to the meaning of important parts of the Regulation. In other cases, either the EU provides the clarity and the circumstances may differ between industry sectors, so this is no small undertaking or it makes it clear that it is ready to see industry sectors come forward with proposals, including best practices and their underlying interpretation, for endorsement by the EU.
In all cases, all stakeholders need to be fully-involved from the start in the implementation process and development of guidance so we can move towards the legal certainty, practicality and clarity that are essential for the achievement of the goals of the Protocol. Otherwise we risk undermining the potentially beneficial impact of the Protocol and killing R&D on genetic resources in the EU.3