Yesterday , Today and Tomorrow : an ethical future for SynBio ?


Recommendation No 1:
The Group recommends that any use of synthetic biology should be conditional on specific safety issues identified in this Opinion. Therefore the Group asks:
1) The Commission to initiate a study on current risk assessment procedures in the EU. The study should (a) make a survey of relevant bio-safety procedures, (b) identify possible gaps in the current bio-safety regulation to effectively assess organisms and novel products developed through synthetic biology; (c) indicate the mechanism to fill the identified gaps.
2) The identified risk assessment procedure should then be carried out by the competent Authorities within the EU (e.g. EC, EMEA and EFSA) and National Authorities.
3) This should be conditional for financing of synthetic biology research and the marketing of synthetic biology products in the EU.

Recommendation No 2:
The Group proposes that, when the above biosafety rules are defined, the Commission starts an international debate with relevant counterparts to facilitate a standardized approach to bio-safety of synthetic biology for public and private funded trials. Instruments for the monitoring of the implementation of such provisions should be conceived as integral part of the bio-safety rules (including fiability issues).

Recommendation No 3:
The Group advocates that a Code of Conduct for research on synthetic microorganisms should be prepared by the Commission. The Code should, for example, assure that synthetic biology organisms are manufactured in a way that they cannot autonomously survive if accidental release into the environment would take place.

Environment applications

Recommendation No 4:
The Group recommends that before an organism, fabricated or modified via synthetic biology, is released into the environment, ecological long term impact assessment studies must be carried out. Data resulting from such studies should then be evaluated taking into account the precautionary principle (214) and the measures foreseen in the EU legislation (Directive on the deliberate release into the environment of genetically modified organisms). In the absence of a favorable assessment the release of organisms fabricated or modified should not be authorized.

Energy and sustainable chemical industry

Recommendation No 5:
The Group proposes that the use of synthetic biology for alternative energy supply in EU Member States would be complementary to the EU renewable energy plan, and that international research trials (e.g. EU-USA) be promoted and co-financed to favor an integrated international approach.

Recommendation No 6:
The Group recommends that competent authorities properly monitor the authorization procedures for the production of synthetic biology-derived chemicals and materials, if not identical to equivalent substances, by taking into consideration (a) risk assessment factors and (b) safety of workers exposed to synthetic biology chemical agents and (c) environment protection.

Recommendation No 7:
The Group asserts that the protection of consumers´ rights is a key factor to consider in EU market and stresses that labeling of specific synthetic biology products, such as cosmetics and textiles, should be explored.

Biomedicine and biopharmaceuticals production

Recommendation No 8:
The Group recommends that further to the application of scientific and legal frameworks, specific ethics considerations have also to be addressed by the competent Authorities (such as EMEA(217)) when drugs and medical products will result from synthetic biology protocols. Data on medical applications of synthetic biology carried out in EU MS or resulting from EU funding should be collected by relevant bodies in the countries where such trials take place and made available internationally.

Biosecurity, prevention of bioterrorism and dual uses

Recommendation No 9:
The Group recommends that the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction should incorporate provisions on the limitation or prohibition of research in synthetic biology.

Recommendation No 10:
The Group asks the Commission to define, in consultation with the EGE, a comprehensive security and ethics framework for synthetic biology.

Recommendation No 11:
The Group recommends that the European Commission:
1) Ensures that databases are available to all who use them;
2) Provides the legal systems for companies to report to Competent Authorities when asked to synthesize suspicious sequences whilst ensuring privacy;
3) Identifies the chain of responsibility for placing particular sequences in the database(s) and identifying them as potentially harmful.


Recommendation No 13:
The Group urges the Commission to propose a robust governance framework for synthetic biology and put it in place in the EU. The Commission should review the legislation applicable to synthetic biology and assess its relevance to address the issues raised by synthetic biology. The above framework should address relevant stakeholders (scientists, industries, military agents, and political and administrative agents) and clearly indicate their responsibilities.

Recommendation No 14:
The relevant science communities should be encouraged to establish ethical, preferably global, guidelines which may act as signposts and lead science institutions and individual researchers to assess the impact of their work including the consequences of misuse (221).

Recommendation No 15:
EGE Proposes that the EU takes up the question of governance of synthetic biology in relevant global fora.

Intellectual property

Recommendation No 16:
The EGE proposes that debates on the most appropriate ways to ensure the public access to the results of synthetic biology is launched. These debates should include also what can be object of patent and what should be available through open access.

Recommendation No 17:
The EU Patent Directive (98/44/EC) defines the EGE as the Body to assess ethics implications related to patents. The Group urges the European Patent Office and the National Patent Offices to take account of Article 7 of the Patent Directive and refer contentious ethical issues of a general relevance to the EGE for consideration. This is particularly important if a class of inventions that ought not to be directly exploited commercially (222) has to be defined.

Recommendation No 18:
The EGE recommends that when synthetic biology is discussed at international level, including the WTO, the ethical issues associated to the technology should be addressed (226). This should be taken into account in the Doha round negotiations.

Recommendation No 19:
The EGE urges that EU Biosafety standards for synthetic biology products as identified in Recommendations N°1, 2 and 5 of this Opinion are adopted as minimal standards for EU import-export of synthetic biology products.

Science and society dialogue

Recommendation No 20:
The Group recommends specific EU actions to avoid new gaps between EU and developing and emerging countries, or within EU Members States, and to put into effect the Recommendations expressed in this Opinion. Such actions should be introduced in bilateral and multilateral science programs of the EU and in the EU policies concerning

Recommendation No 21:
The Group asks the EU and EU Member States to take actions to promote public debates and engagement amongst the stakeholders in order to identify main societal concerns in the different areas covered by synthetic biology.

Recommendation No 22:
The Group recommends that journalists, editors, including science editors, and other stakeholders promote responsible reporting on synthetic biology.

Recommendation No 23:
In order to promote a comprehensive approach to new technologies by the media the Group asks the Commission to stimulate specific actions, such as, inter alia, creating fora, seminars and courses, addressing the implications of synthetic biology in the media.


Recommendation No 24:
The Group invites the Commission to support basic research in the fields of biology, chemistry, energy and materials science and engineering and applied research as identified in this Opinion. This should be reflected in the R&D EU research Framework Programs budget. A similar invitation is addressed to EU member states in their national R&D programs.

Recommendation No 25:
The Group requests the EU to properly finance interdisciplinary research on the following aspects of synthetic biology:

  1. - Risk assessment and safety;
  2. - Security uses of synthetic biology;
  3. - Ethical, legal and social implications
  4. - Governance;
  5. - Science and society (including media and the public).

This should be reflected in the R&D EU research Framework Programs budget. Similar request is addressed to EU MS in their national R&D programs.

Recommendation No 26:
The Group notes that synthetic biology could lead, in the future, to a paradigm shift in understanding concepts of life. It therefore calls on the Commission to initiate an open intercultural forum to address the issues, to include philosophical and religious input.

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