Three years ago, Brazil launched a television soap opera highlighting the social and ethical issues raised by human cloning. To many, the dilemmas raised by the decision of a geneticist to clone a friend's son (in order to replace another son killed in a helicopter accident) proved an imaginative and innovative way of promoting public discussion on a key issue raised by modern science (see Soap opera puts human cloning in the public eye). Others, however — including, but not restricted to, members of the scientific community — criticised the programme for both overdramatising and oversimplifying the issues, for example, by ignoring the medical risks of the procedures involved.
Similar criticisms have now resurfaced in a real-life soap opera, this one taking place in Brazil's National Congress. Last month, the Chamber of Deputies, the lower of the two houses in the congress, passed a broad-ranging biosafety bill that is intended to set a new framework for regulating a wide range of biological techniques and their applications. In principle, the new bill is due to be discussed shortly in the Senate, whose approval is needed to pass it into law.
In practice, however, given the uncertainty and opposition that the draft has provoked, the next step remains highly uncertain. The challenge to the Brazilian government is to find a strategy that is in the best interests of its citizens, and avoids giving in to those who would place ideological commitment above either good science or responsible democratic control. Unfortunately it is not yet clear that it has managed to do either.
The overall goals of the bill are entirely sensible. Given the increasing number of ways in which modern genetics is having an impact on our lives, it makes sense to establish some broad parameters defining how decisions about the relevant issues should be taken. The bill is intended to replace the current biosafety legislation, which was passed in 1995. In particular, it establishes safety norms and monitoring procedures for activities involving genetically modified organisms (GMOs).
There are, however, two major risks that the government faces in seeking to introduce legislation that will do this both effectively and efficiently. The first is that, by grouping together a set of complex safety and ethical issues into a single, overarching piece of legislation, the government risks losing the flexibility that is needed to cope with individual issues in a more pragmatic way.
This has already happened in the case of cloning, for example, where those who fail to recognise (or accept) the important distinction between reproductive and therapeutic cloning make the task of regulating research in this area much more difficult (and controversial) than it needs to be. There is for example, already considerable ambiguity about the precise wording of the bill in its current form, which has given rise in the scientific community to uncertainty over whether, under the current draft, research on embryonic stem cells will or will not be allowed. For instance, the current bill forbids the production of human embryos intended to be used as biological material; but — in apparent contradiction — it allows for exemptions for therapeutic cloning using pluripotent cells.
Who should regulate?
The second risk lies in the way that the government is shifting to a new, highly political way of taking decisions in this area. At the heart of the new procedures will be a proposed National Council of Biosafety. This body will be directly linked to the office of the president, and will be responsible for both formulating and implementing national biosafety policy. It will be made up of 15 ministers (or their political equivalents) involved in the various areas affected by GM-related issues, including those of science and technology, environment, health, agriculture and justice. And one of its key roles will be to authorise all activities involving the commercial use of GM crops and foods.
In future, the role of the National Technical Commission of Biosafety (CTNBio) — the body that, up to now, has been responsible for giving permission for any research or commercial use of GMOs — will be restricted to giving technical advice to the government and to the new council. Even so, the commission's advice will continue to have a political flavour. Although 12 of its members will be drawn from the scientific community, the remaining 27 members will be directly nominated by individual ministries.
CTNBio will remain responsible for setting the detailed rules under which research with GMOs can be carried out. It will also be responsible for giving permission for research projects involving GM crops, as well as evaluating the risks of such projects and monitoring how they are carried out, seeking out peer-review opinion for commercial requests. But the final decision in all such cases will be taken by the new council.
In many ways, this is a sensible arrangement. The role of any government is to adjudicate on competing claims between different stakeholders, and these are frequently represented by different government ministries. At the highest level of political decision-making, this is what happens around the cabinet table. And, given the fierce public controversies that surround the issues covered by the legislation — particularly the commercialisation of GM crops — it would be short-sighted to ignore the fact that the ultimate decision in this area needs to be political.
But that is not the same as saying that each individual decision should also be taken on political grounds, with the danger that such decisions could each end up the result of political horse-trading rather than clear and transparent reasoning. Furthermore, there is a danger that, in the proposed system, the voice of the public will be ignored, as there will be no opportunity for public hearings on issues facing the new council (these will be restricted to issues that are addressed by the newly-demoted CTNBio).
Local biosafety committees
The new law contains many sensible developments. For example, all institutions engaged in genetics-related research will be required to establish their own biosafety committees, in order to inform workers and other members of society of the potential health and safety hazards associated with such research. These committees will also be responsible for setting up risk prevention programmes, carrying out safety inspections, and investigating accidents involving GM plants or other organisms, or diseases that might be the result of exposure to them.
The proposed legislation also creates a fund for supporting the development of biosafety and biotechnology for research in public organisations, mainly to develop and support products that are used by families of smallholder farmers, and form part of the so-called "basic basket" (the main food products used by poor families, such as rice, beans, and cooking oil).
Yet the government's strategy means that those who have legitimate concerns about the potential environmental threats of GM crops find themselves in an uneasy political alliance with opponents of all research using embryonic stem cells. Furthermore the scientific community is protesting strongly that some of the proposals contained in the draft legislation would significantly impact on the conventional freedom of researchers – although their critics argue that this is essentially a smokescreen to protect research that is being carried out with the support of private companies, making arguments over academic freedom irrelevant.
It would be wrong to underestimate the complexity of these issues. But that is all the more reason for allowing them to remain as open as possible to public debate, and not to foreclose the opportunity for such debate by adopting rigid, if unfocused, criteria for what is and what is not allowed.Link to the final text of the legislation approved by the Chamber of Deputies (in Portuguese)
David Dickson and Luisa Massarani