The Ethics and Deliberate Release of GMOs

- Tade Matthias Spranger, Ph.D.
Research Fellow, University of Bonn,
Institute for Public Law (Dept. Administrative Law),
Adenauerallee 24-42, 53113 Bonn, Germany
Eubios Journal of Asian and International Bioethics 11 (2001), 144-146.

With 'Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EC' (1) the European Union's politics on biotechnology once more executed an important change of course. Just a few years ago, in 1998, by amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (2), the EU gave the impression that it wanted to loose the so-called process approach, according to which every use of genetically modified organisms is estimated to bear a risk. However, Directive 2001/18/EC illustrates that the European Union is still far away from accepting the United States' product approach, which qualifies biotechnology per se as harmless. Instead, once again, the Union strengthens the biotechnology critics' position.

First of all, in its legally non-binding elements, Directive 2001/18/EC states that respect for ethical principles recognised in a Member State is particularly important. Hence, Member States may take into consideration ethical aspects when genetically modified organisms (GMOs) are deliberately released or placed on the market as or in products (3). As a well known example, religious beliefs may influence the dealing with products containing GMOs, especially the labelling of Novel Food. For instance, Jews and Muslims will wish to know if food products contain genes from animals such as pigs (4). In view of consumers' rights, this handling is of paramount importance as far as placing on the market is concerned. However, recital 9 of the Directive expands the ethical aspect's relevance to questions of deliberate release, especially field trials. This leads to the basic question if field trials are 'ethically relevant' in any way and if a vague frightened feeling is qualified as an argument against an intended approval. Although, according to a new understanding, environmental law is not free of ethical implications at all (5), this does not lead to the result that every interference with nature requires an institutionalised ethical examination. Certainly, for thousands of years, the development of law has been influenced by morals (6). Nevertheless, one has to oppose law's necessity to incorporate moral standards as a compulsory exercise.

Therefore, regarding deliberate release of GMOs, the development and definition of legally binding ethical aspects are of paramount importance for the Directive's range. Recital 57 tries to lay the foundations for the necessary dialogue. According to this provision, the Commission's European Group on Ethics and Science and New Technologies should be consulted with a view to obtaining advice on ethical issues of a general nature regarding the deliberate release or placing on the market of GMOs. However, such consultations should be without prejudice to the competence of Member States as regards ethical issues.

However, although the Member States' competence is underlined, the Directive increases the Union's 'ethical competence'. Art. 29 of the Directive elucidates this development. According to Art. 29 sub-section 1 (again without prejudice to the competence of Member States as regards ethical issues) the Commission shall, on its own initiative or at the request of the European Parliament or the Council, consult any committee it has created with a view to obtaining its advice on the ethical implications of biotechnology, such as the European Group on Ethics in Science and New Technologies, on ethical issues of a general nature. Furthermore, this consultation may also take place at the request of a Member State. The mentioning of the European Group is just exemplary. As a result, Art. 29 sub-section 1 extends the objective revealed in recital 57.

In summary it may be said that, to some extent, the Directive generates some kind of bioethical chaos (7): At first sight, the ethical evaluation falls within the original Member States' purview. However, without any restrictions, the European Union's bodies shall consult bioethics advisory boards, too. The problem is that neither quality nor quantity of this bioethical consultation is regulated. As described in its headline, Art. 29 aims at the consultation of committee(s) on ethics. That means the cumulative consultation of several institutions is explicitly allowed. But what happens if the Commission, the European Parliament, the Council and some of the Member States want to question different committees about ethical issues all at a time? And what is the practical outcome if Member States' ethical assessment differs from the Union's point of view? By now, these urging questions remain unresolved. A legal solution should take into consideration that the applicant's justified interests require a concise course of procedure and clear rules of procedure. In addition, in case of errors in procedure, an applicant's remedial right should be granted.

Another specific problem concerns the committees' proceedings. Certainly, the Directive tries to defuse the risk of opaque procedures. In its Art. 29 sub-section 2 the Directive states that the consultation is conducted under clear rules of openness, transparency and public accessibility. Furthermore, its outcome shall be accessible to the public. Nevertheless, the rules of openness, transparency and public accessibility could be object of extensive interpretation. Therefore, the definition of these basic terms is of outstanding importance. According to the EU-U.S. Biotechnology Consultative Forum's Final Report (8) regulatory processes should be and be understood to be, open, transparent and inclusive. These characteristics are declared as inherently appropriate in democratic societies. Moreover, not insignificantly, the inclusion of a wider range of views throughout the process may raise substantive issues that might otherwise have been overlooked. According to the Forum's recommendations, elements associated with openness and transparency include requirements that the regulatory authority:

- Notify the public that a new application for product approval has been received.

- Place all relevant non-confidential scientific information about application in the public record and on the Internet immediately upon receipt.

- Discourage the maintenance of information as confidential, unless confidentiality serves an essential business purpose.

- Accept comments in writing.

- Hold formal public meetings and use other mechanisms of public participation to provide the opportunity to offer comments and address regulators and scientists performing risk assessments.

- Publish a final decision, the reasons for it and the supporting data.

- Accept written comments and consider holding a public meeting before the decision becomes effective.

- Provide an opportunity for the public to note concerns that may arise after the product is on the market (9).

Although the applicant's legal interests are clearly subordinate to the public interest in information, this regulatory framework, as a general arrangement, reflects the minimum standard of what rules of openness, transparency and public accessibility may be. Hence, Art. 29 sub-section 2 of the Directive should not remain under this level.

Despite these, at present, theoretical concerns, with regard to International Trade Regulation (10), the Directive's glaring potential for trade-related conflicts has to be mentioned. Because of their non-scientific character, ethically based restrictions may constitute trade barriers. Just as the labelling of Novel Food in compliance with socio-economic considerations collides with WTO law, i.e. the WTO's Agreement on the Application of Sanitary and Phytosanitary Measures (11), a European authorities' observance of a committee's veto may establish an inadmissible non-tariff measure.

As a r_sum_, the situation created by Directive 2001/18/EC is out-of-balance. The clash of individual and common interests calls for a righteous consideration of all facts and circumstances. However, reservations against the deliberate release of GMOs because of expected, vague adverse effects which are far away from being proved cannot outweigh the applicant's rights. To put it the other way around: Mere ethical considerations are not qualified for balancing of lawful interests in the context of licensing procedures. Therefore, a useful and valid execution of Art. 29 of the Directive requires the fulfilment of the following four conditions: a.) The possibility of unlimited interposition of committees by different parties has to be restricted; b.) The committees proceedings should be strictly formalized; c.) The applicant's rights, e.g. committee's obligation to hear the parties or legal action, have to be strengthened; and finally d.) Compatibility with International Trade Regulation has to be guaranteed.


1) O.J. L 106/1 17.4.2001.
2) Council Directive 98/81/EC of 26 October 1998, O.J. L 330/13 5.12.1998.
3) Recital 9 of Directive 2001/18/EC.
4) Murphy, Biotechnology and International Law, [2001] 42 Harvard International Law Journal, 47, 74 (footnote 107).
5) Cf. Alder/Wilkinson, Environmental Law & Ethics, 1999.
6), Hart, Law, Liberty, and Morality, 1971, 1; Lyons, Ethics and the rule of law, 1984, 7 et seq.
7) In general: McLean, Controlling the Future ? \ Human Rights and Biotechnology, [1999] 6 Maastrict Journal of European and Comparative Law 299, 302.
8) The EU-U.S. Biotechnology Consultative Forum, Final Report, December 2000 ( [29 June 2001].
9) The EU-U.S. Biotechnology Consultative Forum, Final Report, December 2000, 14 et seq.
10) In-depth: Mc Govern, International Trade Regulation, Issue 10 (November 2000).
11) Cf. Spranger, WTO-rechtliche Probleme der Genehmigungspflicht f_r neuartige Lebensmittel im Hinblick auf das SPS-_bereinkommen, [2000] 27 Zeitschrift f_r das gesamte Lebensmittelrecht 111.

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