It is amazing how much trouble one paragraph of one article of a single piece of legislation can cause. Such is the case with the soon to be canonised or killed article 53(b) of the European Patent Convention (EPC). It is on its way to causing the downfall of one of the EEC biotech industry's most prized manoeuvres in political history: trying to make life forms patentable despite all the formidable ethical and legal obstacles.
While NGOs have been pointing to the steadfast legal prescriptions of this article for years now, the European Parliament took its first whack at it during two successive public hearings held in Brussels last May. The first took place in the Legal Committee, which is responsible for drawing up the Parliament's report to Council on the proposed EEC directive on patenting in biotechnology. The second was held in the Agricultural Committee, which, responsible for submitting an opinion on the text, has taken a keen interest in the implications of life patenting. The outcome of both sessions can be summed up in one word: conflict. Conflicts of interests, conflicts of analysis, but, especially, a keen and unanimous realisation of how the EEC's proposal itself is in conflict with a binding legal treaty, the EPC's famed 53(b).
Article 53(b) excludes plants and animal varieties from patentability in its contracting states, mostly the EEC. The European Commission's directive would allow for the patenting of all plants and animals that are not called, in the patent application, "varieties". That solves nothing for the farmer, of course, as he can 't plant a "genera" or a "species", but always a well-defined and stable group of seeds that bear consistent characterisistics. That is a "variety" and no super-gene or other biotech breakthrough can make it to the farmer's field if it is not fixed and expressed in a crop variety. While never saying varieties will be patented, the proposed directive neatly provides for the extension of patent rights on genes, gene fragments, processes and so on to the products they are incorporated in, i.e. varieties.
The Parliament was not duped. Their public consultation with invited experts in May brought them to the clear and angry conclusion that the Commission wanted them to blindly approve a text that would bring member states into conflict with binding commitments to the EPC, all to the one-sided satisfaction of a small group of companies that dominate research in biotechnology. Those companies and the Commission tried to find a way around EPC 53(b), through this directive, without renegotiating the European Patent Convention, which would call for tedious and highly visible diplomatic negotiations. They may not succeed, should the Parliament take its role seriously.
Mr. Willi Rothley, who is responsible for drafting the Parliament's report, insisted that the Commission proposal "goes way beyond what is happening in the United States or Japan," in this field. Indeed, the Commission failed to exclude human beings and their parts from patentability which would only "confirm what is happening in practice," according to speaker Marie-Angèle Hermitte. She explained that human cells are being patented already and if no limits are set by the policy-makers, we will have to expect that the human genome -- humanity's genetic blueprint -- will become somebody's property as well.
Discussions in the two hearings focused mostly on ethics and agriculture. Experts explained how plants and animals were originally kept out of the European patent system for ethical reasons regarding the overrriding importance of keeping the food supply away from the abuses of monopoly control. Farmers organisations pleaded for maintaining the integrity of the plant breeders ' rights system, which the patenting directive would effectively undermine. PBR allows breeders to use each others ' protected materials for further improvemnt (the so-called principle of "free access to genetic resources" or breeder's exemption) and permits farmers to re-use harvested seed for future plantings (farmer's privilege). But the biotech industry find these rights rather feeble and wants full patent protection.
In fact, the Commission's entire approach to patenting life forms is that only biotechnology can feed the world. The directive blames traditional plant breeding for all of Europe's agricultural ills, from surpluses to pesticide residues, and claims that biotechnology will be the key to curing these faults. In a most violent fit of political emotion, rare among responsible civil servants, Commission representative Berthold Schwab, from the Industry Directorate which drew up the life patenting proposal, screamed to the hearing participants, "If we want to prevent half of the (world 's) population from dying of starvation in the coming century, then we obviously cannot reach that objective with biological methods alone." In other words, only the genetic engineers can do it and for that to happen, they need to have monopoly protection available. To press the point, Schwab got even redder and angrier, shouting to the Parliamentarians, "If you are saying that we should accept that billions of people die of starvation because we don 't have patent protection available (for biotechnology), the Commission cannot go along with this!"
Now that the Parliament has commenced its deliberations on the proposal, which will take several months, let us hope that they command a bit more intelligence and respect for society at large in their work than the Commission is apparently capable of.
Quotes taken from the recorded transcript of the session.