by Adrian Ely, Vanesa Lowenstein and Yuhan Bao

As part of the STEPS Centre’s final event on 8 December, we’ll be reflecting on the changes since the Centre’s project ‘Rethinking Regulation’  which took place between 2006 and 2011.

The Rethinking Regulation project compared the regulation of two biotechnologies – transgenic seeds and antibiotics – with the way those technologies are experienced amongst poorer communities in rural Argentina and rural China. An international team explored the gaps between assumptions underlying globally-harmonised regulation – which is often based on the norms of OECD countries – and the more complex realities in which the technologies are adopted and adapted to suit diverse, dynamic contexts.

Rethinking Regulation: seeds and drugs in China and Argentina

A key message from the project was that international and national regulation struggles to address these complexities, and especially to incorporate and prioritise the issues relevant to more vulnerable communities. The project aimed to understand how to improve regulatory capacity, and to identify fruitful ways of rethinking regulation.

In the decade since the project finished, the technologies, institutions and geopolitics around biotechnologies have changed dramatically. In our session, we will be focussing on gene editing and synthetic biology; we’ll consider the challenges of regulation in the domains of biosafety and intellectual property.

Two international frameworks, the WTO TRIPS Agreement (and chapters of intellectual property rights in free trade agreements), and various protocols to the UN Convention on Biological Diversity that we discussed in our book ten years ago, represent areas where Argentina and China are again playing important international roles.

Argentina, regulation and trade

Argentina is in a very interesting position. It has a strong agricultural sector (with agricultural exports in some years making up approximately half its foreign exchange), and it needs to consider the regulation in these export markets in its own regulations. In 2015, Argentina was the first country to codify its biosafety law around gene-edited crops, but uncertainties over equivalent regulations in the European Union, for example, may mean that cultivation requires farmers to go beyond mere compliance.

Similar issues arise around intellectual property. Ten years ago, Monsanto put pressure on shipping companies to ensure licenses had been paid on their proprietary GM soya before they transported shipments from Argentina to the EU. When it comes to gene-edited crops, it’s unclear whether any patent rights on these types of products can or will be enforced. Article 27 (3b) of the TRIPS agreement allows Members to exclude from patentability “plants and animals other than micro-organisms”; Article 28 (1b), however, allows for process patents like those relating to CRISPR-Cas9 (and associated products).

Argentina is responding to various strategic and political pressures in formulating its policies in these areas, which mainly concern large farms serving export markets. However, the extent to which the interests of smallholder farmers are taken into account remains in question. Alternative approaches such as the open source seeds initiative Bioleft attempt to circumvent these IP issues, serving the interests of smaller farmers by seeing genetic information in seed as a protected commons. Bioleft is one of the activities emerging from the ‘Pathways to Sustainability’ network: it represents a more bottom-up attempt to regulate technology, in a way that prioritises the needs of those who are excluded from more formal national approaches, although it works more with conventional seeds and farming techniques.

China’s changing role

China’s role on the international stage is also changing, as the country invests heavily in synthetic biology of different kinds, and assumes a leadership role in terms of patents on gene editing.

China is hosting the UN Convention on Biological Diversity Conference of the Parties in Kunming this year, and ratified the Cartagena Protocol on Biosafety in 2005 (see this paper for a discussion of local implementation).  Following the agreement of the Kunming Declaration in October, biotech regulation, access and benefit sharing are among the many items on the agenda for discussion.

Beyond formal negotiations, the Sharm el Sheikh to Kunming Action Agenda for Nature and People invites stakeholders to come forward with their own voluntary commitments. One among these is a ‘Declaration of China Synthetic Biology Youth Researchers on Responsible Research & Innovations and Biodiversity Protection’, which has the ambition of becoming an international initiative. The effort follows similar processes convened in China, such as the Tianjin Biosecurity Guidelines, which gained international support from the Inter-Academy Partnership earlier this year.  These represent examples of ‘self-regulation’ from within the bioscience community – an idea with a history dating back at least as far to the Gordon Research Conference on Nucleic Acids in 1973.

Relevant lessons

At the same time, these examples – of Bioleft as a platform for open innovation, and of self-regulation in synthetic biology – illustrate that several of the findings from the earlier ‘Rethinking Regulation’ project remain relevant:

• Room to manoeuvre afforded by international law (eg TRIPS and Cartagena) translates to flexibility in national level regulations. Countries set their own formal regulations in a way that responds to domestic strategies, politics and capabilities.
• Beyond this, at subnational/ local levels we see varying (and dynamic) levels of implementation/enforcement of formal regulation, which depend on the financial stakes at play, domestic and international politics and the gaps with ground-level realities.
• In response, we see initiatives that circumvent formal regulatory frameworks in an attempt to deliver technological benefits to poorer communities.
• We also see approaches to ‘self-regulation’ that in some cases aim to go beyond compliance and strive for safer/more responsible forms of research and innovation.

There are also emerging issues that we could not have considered ten years ago. As technological capabilities for gene editing and synthetic biology become more widespread, the challenges of national/international coordination become more acute.

We look forward to discussing some of these challenges at the STEPS Centre’s final event, with a view towards future work that investigates the implications of knowledge, politics and power in the regulation of technology.