The EU has taken a step closer to ratifying a protocol that aims to prevent exploitation by the pharma industry and other sectors of the natural resources of indigenous communities around the world.
Members of the European Parliament (MEPs) yesterday voted in favour of adopting the Nagoya convention drawn up by the United Nations (UN) in 2010, an add-on to the Convention on Biological Diversity (CBD) that came into effect in 1993.
The CBD has the objectives of conserving biological diversity, promoting the sustainable use of natural resources, and “fair and equitable” sharing of benefits arising from the use of genetic resources.
The protocol is trying to prevent situations in which a pharma company could – as an example – tap into the traditional medicinal knowledge of a region to create a new medicine based on a compound found in a herbal remedy, without providing fair level of compensation to the indigenous community.
French Green MEP Sandrine Bélier, who has been leading the proposal through the European Parliament, has long argued that European pharma companies have exploited the biodiversity of less developed regimens such as Africa and Asia, illegitimately gaining patents on genetic resources derived from traditional knowledge.
One notable example involved German company Schwabe, which filed patents on a medicine derived from the South African geranium species Pelargonium sidoides and has been selling a branded product derived from it, called Umckaloabo, as a respiratory remedy.
The patents were revoked in 2010 after appeals from the Berne Declaration in Switzerland and the African Centre for Biosafety, despite claims by the company that it used a novel extraction process and that the herb had been used as a remedy in Europe for more than 100 years.
The Nagoyo protocol starts with the premise that the intellectual property (IP) for natural resources defaults to the indigenous communities where they are found. It then provides a legal framework for the ‘fair and equitable’ compensation elements of the CBD and lays out due diligence requirements the users of genetic resources will have to adhere to, or face sanctions.
The MEP vote creates a precedent EU member states must follow when introducing the Nagoyo protocol into their national laws, although it must still be ratified by European Council before passing into EU law.
“The international negotiations which led to the adoption of the Nagoya protocol on access and benefit-sharing was a lengthy process, and the result struck a fair balance between all the interests concerned,” commented Janez Potocnik. European Commissioner for the Environment.
“On the one hand [it] concerns biodiversity conservation and our respect for other countries’ sovereign rights, and the rights of indigenous and local communities related to traditional knowledge associated with genetic resources; and on the other it has important implications for European innovation and economic growth,” he added.
Earlier this year the European Federation of Pharmaceutical Industries & Associations (EFPIA) voiced its support for the Nagoyo protocol in a position paper (PDF), whilst also expressing its concern and regret that the drug industry had been singled out in the text.
EFPIA notes that most of the large pharma companies no longer have active programmes seeking out natural products, and this activity tends to be carried out by smaller drug developers and scientists in academia.
So far, 16 countries around the world have ratified Nagoyo, which must have 50 signatories by July 2014 if it is to come into force.