Two weeks ago, I attended the 8th Berlin conference on IP in Life Sciences, hosted by the South African Embassy in Berlin, Germany. Besides the wonderful setting for the conference, the quality of the presentations and discussion was of the highest standard, which is increasingly rare, especially on such a topic. The audience consisted of explorers, scientists, entrepreneurs, innovators and lawyers, who were enthusiastic about the potential and value of natural products and trying to understand what they may or may not do, and how to do what they have to. As is often the case, I’m afraid, we all left the room with a few new answers to old questions, and yet more questions.
We all agreed on the amazing potential of natural resources, whose biological structure and function have evolved into something close to perfection. Worldwide biodiversity suggests an endless reservoir of resources, some known but most unknown, which are certainly worth exploring after all the low-hanging fruit has been picked and we are striving to come up with the next generation of medicines e.g. antibiotics.
This potential however is difficult to reveal and to harness. Firstly, because most of these resources are neither easily available nor accessible and that is why it is critical that SMEs, universities and collaborations can continue to bio-prospect, to collect, to document and to study unknown areas of our world. Secondly, because using this potential and translating it into an effective and safe medicine is a long and difficult process.
With this come more challenges for those we call “users”. Patentability is just one of them but a good deal prior to that, it is worth noting that the legal framework for access to and use of genetic resources is a new and major unknown for all stakeholders. Building on the Convention on Biological Diversity, whose core objective was to encourage the sustainable use of natural resources worldwide, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilisation was adopted in 2010, and provided a framework on which to build. This Protocol entered into force in July 2014, and now needs to be implemented by its parties. As usual, though, the devil lies in the details. This truth was borne out by three speakers arriving at the same conclusion.
This is certainly true for EU Regulation no. 511/2014 on compliance measures for users from the Nagoya Protocol which, as is the case with the CBD and the Nagoya Protocol, relies on a very traditional and old-school model of bio-prospecting. Here, a single scientist would collect, research and develop a natural resource into a product.
The way pharmaceutical companies operate has nothing to do with that anymore. The Regulation failed to account for the complex commercial reality that R&D has on natural resources today. The fact is that genetic resources used within the EU are obtained from many different countries, and rarely directly in their country of origin by the users who would be utilising them. They are often traded via various parties and various countries before the user wishing to utilise them in the EU actually acquires it.
Though the Impact Assessment and the Proposal pointed towards a flexible and low-cost due diligence obligation on users to satisfy the compliance pillar of the Nagoya Protocol, the reality of the upcoming system is unfortunately very different. As a result, research opportunities and innovation involving natural products in the EU are seriously threatened. So what has been achieved is actually the opposite of what global and EU policy-makers intended. What users need is a clear legal framework, which offers all users certainty and trust when using natural resources.
In a field in which collaboration between all stakeholders is crucial – from upstream acquirers to downstream users – awareness is key. However, most links in the value chain are clueless as to what the Protocol implies or actually lack the resources to play their part in the due diligence process. Perhaps the biggest challenge is therefore to get everyone on board. Above all, understanding is key and sharing the burden is critical if the EU wants to encourage the utilisation of natural products, and if their potential is to be transformed into something useful to the citizens of the world.3