An excellent workshop on the regulation of animal biotechnology occurred in Brasilia August 18-21. It was the second international workshop on the topic, and was attended by the best specialists in the area of regulatory framework in biotechnology. I was invited to deal with challenges and opportunities for harmonization in the animal biotech field.
The theme is extremely complex. So much so that specialists agreed that a third workshop will be needed shortly. The problem is that animal biotech is a newcomer in this business. Few products have been registered by the FDA, and some have been waiting for years, such as the GM salmon of Aqua Bounty. When recombinant DNA technology started early in the seventies, the concern from scientists was over the possible use of virus as vectors in projects related to genetic engineering, which didn’t come to fruition until two decades later. A moratorium was established, until the US National Institutes of Health put forth guidelines, which were adopted globally.
Science and technology has moved fast since then, faster than we are capable of building regulations to oversee it. In fact, we are still discussing genetic engineering in many countries, with new technologies emerging – synthetic biology and gene editing, to name a few – for which a regulatory framework has not yet been built.
In my last post, I mentioned that paradigms were shifting to allow the expression of genes coding for monoclonal antibodies in the milk of mammals, and in plants. Since then Mapp Biopharmaceutical and LeafBio used a tobacco-plant strain found in Australia to create a cocktail that fuses three monoclonal antibodies, which was shown to be capable of protecting monkeys from Ebola virus when administered immediately after exposure. FDA approved the use of this experimental drug without data from clinical trials, considering the urgency of the Ebola crisis in Africa.
This decision is under severe criticism by those with other experimental vaccines under development. The issue is that there is no regulatory framework available for these nascent technologies. As biotechnology moves along new avenues, it will be harder to create and harmonize regulations. The regulatory framework to deal with biosimilar monoclonal antibodies is not yet in place but the products will be to the market soon.
Another issue is how to define international harmonization. There are international guidelines that are not obligatory but facultative in nature, such as the Codex Alimentarius, and there are protocols, such as the Cartagena , Nagoya and Kuala Lumpur Protocols related to the Convention of Biological Diversity. Protocols may become legal instruments after being adopted by countries, but this takes time and does not satisfy the urgent need of “harmonization” demanded by nascent technologies and/or Ebola epidemics.
How to manage this complex issue? I’d suggest it be done on a case-by-case basis. Biotechnology is science but also a business. When one country wants to adopt a new technology from another, the law to be adopted is that of the first country by the second. The country transferring the technology will have its own legislation about the matter, and the two legislations must be harmonized. Or at least compatible, for if they are not, then the transfer won’t happen and both sides will lose.
The role of countries at the forefront of science and emerging technologies is to anticipate adopting new technologies and have the appropriate rules at the ready. This way laws can be harmonized and tweaked when opportunities for international technology transfer arise.
Luiz Antonio Barreto de Castro
