A critical analysis of the Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin on the basis of the comments made by the experts participating in its public consultation process
| Autor | Iñigo De Miguel Beriain/Simone Penasa |
| Páginas | 121-141 |
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On 11 May 2016, the Council of Europe adopted the Recommendation CM/Rec(2016)6 of the Committee of Ministers to member States on research on biological materials of human origin. This new legal tool updates the previously existing Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin of 15 March 2006 by taking into consideration new developments in the field of biobanking1. It is meant to play a key role in the harmonisation of the regulation on the topic addressed in the Council of Europe geograph-ical scope, and even beyond.
The main purpose of this paper consists of developing a critical analysis of the new Recommendation on the basis of the comments made by aca-demics, representatives of the biotechnology industry, members of the ethics committees, professional and patient associations, national agencies, etc. in a public consultation organized to refine the preliminary draft of the document. Indeed, in the next pages we will offer a detailed account of its main clauses while comparing them with the suggestions made by the participants in the consultation, highlighting the main disagreements that remained in its final versión. In this way, we will contribute to the most recent stage of development by performing a valuable analysis of the document and by including a critical comment on the utility of the public consultation made during the process.
The elaboration of Recommendation CM/Rec(2016)6 was the logical consequence of the provisión included in Article 26 of Recommendation (2006)4 of the Committee of Ministers on research on biological materials of human origin, which stated that "This recommendation should be re-examined not more than five years after its adoption, notably in the light of the experience acquired in the implementation of its guidelines". The revisión process, however, was not launched until 2012. At that moment, the DH-BIO división of the Council organized the Symposium on biobanks and biomedical collections: an ethical framework for future research, which drew a very interesting analysis of the scientific, social, ethical, and legal background that had been raised in the aftermath of the redaction of the original Recommendation. Soon afterwards, in December 2012, the DH-BIO created a working group entrusted to prepare proposals for the revisión of Recommendation (2006)4.
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The group presented a preliminary draft of a revised Recommendation which was discussed by the DH-BIO during its third (28-30 May 2013) and fourth (26-28 November 2013) plenary meetings. It was the Council's decisión to complement these meetings with a public consultation process that involved a considerable number of academics, members of the industry, patient organisations, national agency representatives, ethics committee members, etc. The consultation was held between March and August 2014, and the comments submitted to the Consultative Committee of the Conven-tion for the Protection of Individuáis with regard to Automatic Processing of Personal data (T-PD), which was responsible for integrating the comments in the final versión of the Recommendation. The final content of the Recommendation was mainly decided in the DH-BIO meetings held on 4-7 May 2015 and 1-4 December 2015. An Explanatory Memorándum2 was written in order to provide detailed explanations on the Recommendation, including the purposes that justified its concrete clauses and its most suitable inter-pretations.
As mentioned, the Public Consultation was made on a preliminary draft of the new Recommendation, a working document redacted by the working group. This preliminary versión was divided into six chapters containing twenty-five articles in total. At the time of writing the terms of the consultation, the working group stated that it would be particularly interested in receiving comments on three main issues: Storage for future research of residual biological materials (Article 13); Removal, storage and use of biological materials from persons not able to consent (Articles 12, 14 and 17, paragraph 4); and Govemance (Articles 20, 21, 22, 23 and 24). In practice, most of the commentators felt free to introduce further comments. Indeed, the consultation generated a broad document3, in which most of the articles were carefully analyzed and an impressive number of suggestions to im-prove them obtained. Moreover, it is relevant to remember that the range of experts consulted included representatives of different social agents, such as the biotechnology industry, patient and professional associations, academics, policy makers (including members of national agencies and ethics
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committees), etc. Therefore, the feedback received was extremely valuable on the basis of its multidisciplinary nature and cross-sectorial provenance.
The consultation brought different type of responses. Some of the comments made were very critical of the document4, while some others generally supported the fundamentáis of the text5. There was fairly general agreement on the adequate balance between the significant room for na-tional interpretation and the common floor regulation set by the Recommendation6. Even if harmonisation was an essential objective of the document, it seems clear that cultural differences existing at the national level7 would have made impossible a fixed, not flexible, common regulation. However, experts criticised the fact that the Recommendation did not properly take into account the existence of different legal tools devoted to guaranteeing an adequate regulation of biological materials treatment at both the national and regional levéis. Similarly, criticism was made regard-ing the way in which the document addressed issues posed by biological materials related to rare diseases, which are in need of broad informed consents8. Experts also urged the responsible group to improve the part of the draft Recommendation referring to their international mobility9.
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The final versión of the Recommendation introduced some changes that correspond in some way with the opinions received, even if it is impossible to know to what point they were the triggering factor. Firstly, a change in the order of the articles was made, including the cancellation of Article 7, related to identifiability, which reflected a clause that already existed in the Recommendation of 2006, but which was generally criticised by the ex-perts. Secondly, the use of the concept of anonymisation was generally avoided, a circumstance that worked well with the opinión expressed by a vast majority of the experts who participated in the consultation. Some other issues, however, remained. In the next pages, we will make a detailed com-ment on them, while exposing the fundamentáis of the Recommendation.
The new Recommendation is divided into several different parts. It in-cludes a Preamble, which is devoted to explaining the main aims of the document, and an Annex (the Guidelines) comprised of five main sepárate chapters that constitute the main body of the Recommendation. These are entitled "Object and scope", "General provisions", "Obtaining and storage for future research", "Govemance of collections", and "Use of biological materials in a research project". A final chapter, "Re-examination of the recommendation", has been included in order to ask for a regular re-examination of the document, in the light of new developments in the field and the experience acquired in the implementation of its guidelines, follow-ing the path traced by Recommendation Rec(2006)4. The only relevant difference is that the new versión does not include a precise period of time in which the review should take place, most probably because experience has demonstrated that this does not work well in practice (let us bear in mind that the provisión included in Recommendation Rec(2006)4 -five years- was not followed by the Council).
According to the Preamble, the aim of the document is twofold. On the one hand, it recommends that the governments of the Council of Europe Member States adapt their laws and practices to ensure the implementation of the guidelines and to promote the establishment of codes of good practice to ensure compliance with those guidelines. On the other hand, it entrusts the Secretary General of the Council of Europe with transmitting the Recommendation to the governments of the non-member States of the Council of Europe, and to other relevant govemmental and non-govemmental intemational organisations. In this way, the Recommendation follows the spirit of all legal documents produced by the Council of Europe, which are traditionally open to third parties. However, the deeper reasons and principies that guided the redaction of the document are included in the previous lines of the Preamble and, more clearly, in the web page of the
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Council, where this can be read: "The purpose of these new recommenda-tions is to spell out and safeguard fundamental rights of the persons whose biological materials are intended for biomedical research. Their dignity, integrity and privacy must be guaranteed, while at the same time the...
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