Fostering Good Bioethics Practices Among the European Biotechnology Industry: Bioethics Report on Biobanks
The project: “From GMP to GBP – From Good Manufacturing Practices To Good Bioethical Practices" is a Specific Targeted Research Project funded by the European Commission, Sixth Framework Programme.
The project aims at integrating bioethical practices as an intrinsic part of industrial standards, just as Good Clinical Practices (GCP) or Good Manufacturing Practices (GMP) are. These standards of Good Bioethical Practices (GBP) would allow the industry to define its own issues and recommendations inform to European Union legislators and relevant authorities. The project also aims to improve understanding of bioethical issues, based on the current practices of biotech companies, as well as to elaborate clear and independent positions on bioethics, based on regularly updated scientific and technological data.
The final step will involve disseminating this information to the industry and to society. The project is piloted by the French biotechnology association, France Biotech, in partnership with a consortium comprising the European Association of Bioindustries, EuropaBio, and national biotechnology associations from Estonia (the Estonian Biotechnology Association), France (France Biotech), Hungary (the Hungarian Biotechnology Association), Sweden (SwedenBio) and Spain (ASEBIO), as well as the French Institute for Health and Medical Research (INSERM U558).
The definition of a biobank varies between European countries. In some countries, the term does not exist in any legislation. Two trends however are evident with respect to the way countries view biological samples and data:
• The first makes a distinction between the physical biological samples themselves, which together constitute a sample collection, and the database made up of the information derived from these samples and their donors.
• The second trend, which currently predominates in the world of genomics, uses the term ‘‘database’’ to denote the physical samples as well as the information derived from them.
The issues most commonly mentioned by stakeholders in the European biotech industry regarding biobanks are:
The definition of biobanks
The absence of a common definition is a source of problems and difficulties in an international context where exchange plays an important role, as well as the harmonisation of regulatory modalities, organisations and operations.
The lack of international regulation
Currently there is no international, legally binding, instrument that applies to biobanks. Instead, biobanks are nationally regulated, through a combination of general and specific laws and oversight bodies, all of which differ greatly from one another. There is a need for a clearer framework and for tools to facilitate the exchange of relevant information.
Informed consent of donors
As described in the Nuremberg Code and the Declaration of Helsinki, the principle of informed consent has largely been recognised and is considered a pillar in the practice of bioethics. Although it does not in itself protect a person, informed consent allows individuals to exercise their fundamental right to decide whether, and how, their body, body parts and associated data can be used in research. The principle of informed consent is applicable for any research on human beings or on human material.
However, how is consent to be given? In general, blanket terms? Or are there some operations (transfer to another country, new kinds of experiments, another domain of application, etc.) where consent should be repeated? For what length of time is consent valid? It is also important to point out that whilst one might assume that most donors are anxious that their samples not be used broadly without their consent, others are anxious about the opposite: that their sample be used as much as possible to help.
The property rights of an individual
Two issues must be addressed regarding property. The first is the individuals’ right concerning their own biological material. The legal approaches to property rights cannot apply and should be adapted for biobank activities. In general there are no property rights on biological samples, as they are body parts that should not be placed in the commercial circuit, but individuals retain a right of control over the use of their body parts.
The second is collaboration between academic researchers and private companies in the development of biobank research. Here, the question of ownership of the collections and intellectual property rights needs to be addressed.
Addressing the confidentiality issue is central to current legislation on biobanks. From the storage of human biological material to its exchange among researchers, confidentiality must be protected.
Access to data
To encourage the production of useful data for research, the number of people available and therefore the number of related samples is increasing. However, the policy by which access is determined needs to be inclusive and systematically defined for each biobank and communicated to the participants at the time of consent, or as early as possible.