TITLE: The Directive That Just Won't Lie Still AUTHOR: Tommy Schweiger and GRAIN PUBLICATION: Jointly elaborated for BIO-IPR DATE: September 2000 NOTE: Fuller reference and contact details below. THE DIRECTIVE THAT JUST WON'T LIE STILL Tommy Schweiger and GRAIN (*) September 2000 If proponents of the European Union's (EU) directive 98/44/EC on "The Legal Protection of Biotechnological Inventions" had thought that its adoption in 1998 was the final step in a tumultuous 10-year saga, they are in for a rude awakening. The directive is back on Europe's political agenda. The deadline for the transposition of the directive into national law was 30 July 2000. But only three countries of the 15 made it. Many European governments have become very reluctant to implement the text which most of them adopted so enthusiastically at the EU level only two years ago. The stumbling block is the question of patenting human genes -- which the directive allows. Cracking the genome cracks the directive Whatever hopes the EU had for smooth transposition of the directive within the deadline were derailed by the announcement on 26 June that the human genome had been decoded. In Europe, this opened up a strong public debate on the question of patentability of human genes. That debate was already on the rise. Just weeks prior to the news that our genetic code had been cracked, US President Bill Clinton and UK Prime Minister Tony Blair called for all human genes to remain in the public domain. And earlier in the year, the publicity over a patent on human embryos, which had been granted by the European Patent Office (EPO) in 1999, caused an unprecedented public outcry. As a result, the German government filed a legal opposition to the patent. Throughout these past months, the anxieties raised by patents on human genes have dug deep into public policy-makers, east and west of the Atlantic. There are several angles to their confusion and doubt: (1) Are human genes inventions or discoveries? Everyone seems to say that "raw" DNA sequences are definitely a matter of discovery. But why would finding out that, say, a protein serves a specific function in the body, and trying to patent its use, amount to an invention? (2) What is the measuring stick of "novelty" and "utility", requirements for patent protection, in the field of gene patenting? The US Patent and Trademark Office is in the process of redefining its very guidelines on this issue. And it is here that the EU directive is notoriously ambiguous. (3) Is it ethical to grant patents over parts of the human genome? Many professional societies, not to mention ordinary citizens, say no. Even the 1997 Universal Declaration on the Human Genome and Human Rights tries to uphold the human genome as "the heritage of humanity". (4) How will medical research proceed if access to information regarding human DNA requires costly licenses and complex negotiations? And what are the implications for the commercial development of new drugs and treatments? To use a famous example, Myriad Genetics in the US holds numerous patents on the BRCA1 and BRCA2 breast and ovarian cancer genes. Myriad has given Eli Lilly and Co., also of the US, exclusive rights to market treatments based on the BRCA I sequence. On its own, Myriad charges $2,400 to $3,500 to sequence a woman's DNA in search of BRCA mutations, which number in the hundreds. The cost is prohibitive, and the company has denied researchers rights to use the test. In the face of these problems, one body after the other has been coming down hard against the patenting of human genes --and the EU directive. The French National Bioethics Committee, under mandate from the Secretary of State for Industry, filed an opinion on 6 June against the directive, calling for a renewal of discussions instead. "Knowledge of a gene sequence," whether of human or non-human origin, the committee stipulated, "cannot in any way be considered an invented product, and is therefore not patentable." Two weeks later, the Ministers of Research of the eight most industrialised countries, the so-called G8, communicated their consensus against the patenting of human genes. Then, on 30 June, the Parliamentary Assembly of the Council of Europe unanimously passed a resolution urging for a moratorium on the patenting of human genes. And if that weren't enough, the Assembly called on EU Member States to renegotiate the directive, not transpose it. The Munich-Brussels fault line If the aim of the EU directive was to harmonise patent law in Europe, it has failed miserably. The situation has become legally more confusing and incoherent than ever before. The European Patent Office (EPO) in Munich has been rolling ahead despite the political wrangling. To date, the EPO has issued hundreds of human gene patents. And it has managed to do so in a very devious way. In June 1999, the Administrative Council of the EPO decided to adopt the EU directive as a guideline for patent examination. That means that the EPO is implementing the rules of directive, even though the EU member states have not accepted it in their national laws! This is all the more twisted since the EPO is not an institution of the European Union. It implements the European Patent Convention (EPC), a treaty drawn by both EU and non-EU countries. To complicate matters further, the parties to the EPC are going to renegotiate their Convention this November. And as far as biotechnology patents are concerned, they do not plan on changing their rules. They plan on sticking with the directive, as adopted by the EU membership in Brussels, as a basis for deciding what is permissible in this field. Even if European governments are not willing to fix the directive in national law? Three strikes, you're out There seems only one way out of the mess: renegotiate the whole directive at European level, for a third time. There are increasingly loud voices calling for this. Several powerful lobby groups, which kept silent during the vote in 1998, have since come out against the directive. Most notably, Germany's very large and influential Farmer's Association recently called for a moratorium on patents on plants and a renegotiation of the directive. The government of Germany is reported to have contacted France and the UK to discuss this possibility as well. To take the challenge seriously, the EU Ministers would need to call on the European Commission to prepare a new proposal. This would appear difficult, since the Commission has always been a strong supporter of the directive. But things might change at the Commission as well. In a recent speech, the Commissioner responsible for Research, Mr. Busquin, implied a need to act: "The rule that the product of a discovery should remain within the public domain but that the fruit of invention work can be protected is clear in terms of principle. However, the conditions under which it is applied in the case of 'genomics' need to be clarified in order to avoid any ambiguity or abuse." Since the biotech directive is Community law in this respect, action is clearly in order. _______________ STATUS OF IMPLEMENTATION OF THE EU PATENTING DIRECTIVE (98/44/EC) Austria Waiting for the outcome of the European Court of Justice's (ECJ) ruling on the Dutch/Italian challenge to the directive before implementation. However, a new debate might be coming up in Parliament over the next months. Belgium After strong internal and public controversy, the Government has put a proposal forward and has asked the public for comments. Denmark After a brief but fierce debate in the Parliament, the directive was narrowly passed, despite its Ethics Committee arguing against it. Finland The directive has been passed by Parliament. France Government officials have spoken out publicly against the directive, saying they do not want to implement it as it stands. In July, the Prime Minister requested the European Commission to issue an interpretation of the directive, without which the French government will not implement. Germany The German government is unhappy with the directive as it stands and, like France, is willing to implement only with major amendments. Is considering renegotiation. Greece The draft law which transposes the directive is at ministry level only, the beginning of a very long process. The government is aware of changing attitudes in other EU countries, but so far has no position on it. Italy The Government is supporting the Dutch challenge against the directive at the ECJ. Before a ruling can be expected, the ECJ will call a public hearing on the case. No date has been set. Luxembourg A national law identical to the directive is due in Parliament mid-October. Netherlands Initiated the challenge at the ECJ, which is based on several legal principles. No concrete plans for national implementation. Norway Norway is not a member of the EU, but as member of the European Economic Area it usually has to implement EU law. The previous government was highly critical of the directive, and did not intend to implement it. The new government can also be expected to be critical. Portugal Currently drafting its national law, which is most likely based on the directive. Spain A first draft law was presented by the government to the European Commission. Brussels determined it was "not appropriate" and sent it back. Sweden A Parliamentary debate is expected not before next year. UK Legislation passed, with hardly any debate, in July. _______________ (*) Jointly elaborated version of an article prepared by Tommy Schweiger for the September 2000 issue of GRAIN's quarterly newsletter "Seedling". It will soon be online at http://www.grain.org. Tommy Schweiger can be contacted at tommyschweiger(at)yahoo.com.