Lithuania: Biobanks – Is Lithuania Ready For Them?

Last Updated: 3 October 2012
Article by Edvinas Meskys

Currently a large part of politicians, economists and lawyers are working hard to ensure that a recent bank bankruptcy story would not repeat itself. Quite often people associate the term "bank" with instability, possibility to lose something or lack of transparent governing. Maybe this is the reason why there are no biobanks in Lithuanian which are wide-spread in the EU and other countries of the world. But maybe the lack of knowledge causes such situation because people often are afraid of things they don't know.

What is a biobank?

There are various definitions of biobanks. One version says that biobank is a well-organized system which stores and manages human biological samples and medical documents for the sole purpose - to achieve scientific research goals. Shortly speaking, a biobank is a place with special tanks where samples of human organs, their parts, tissues, cells or their components, taken from the human body, are stored. All these components have a general name – biological material.

Some people may find the idea of biobanks strange but only this kind of storing and managing system would allow Lithuania to develop new research of cancer, genetic and other diseases, therefore it would serve the interest of the whole society and of each Lithuanian citizen. The purpose of a biobank is to accumulate material for future research after new technologies will be developed or new ways of research will be found, new symptoms of diseases will be discovered, etc. Things that were unclear 20 years ago are easily explainable at present, so we can only guess what kind of possibilities we will have after several decades.

Applicable laws contradict the essence of biobanks' functioning

Under the applicable laws all biomedical researches are conducted only with a written consent of the subject of the research. Before giving the consent, the subject is informed in a form which is comprehendible for him/her and is signed by him/her, about the aim, plan and methods of a particular biomedical research and receives other important information. Biological materials are stored in biobanks and researches in most cases are not planned in advance, therefore there is no possibility to inform the subject who donates the biological material for scientific purposes about the precise details of the research. It is similar to blood donation – a donor does not ask a doctor to which patient his or her blood will be transfused.

Special consent of a person is necessary

A biobank needs a specific-general permit which allows the researcher to conduct a research at any time and as many times as needed in accordance with strict requirements of legal acts and with a consent of the supervising institution. The control of biological material may be ensured by including a provision to the law which would give a possibility for a person to get general information on whether his/her biological material was used for the biomedical research during the last year. Hardly a person who allowed to store in a biobank the sample of the malignant tumour removed during an operation would wish to receive constant calls from the researchers with a request of consent to use the sample. In such cases people wish to forget about the past and the disease and feel happy at the same time that his/her donated medical material could help to find cures or method of treatment of the same disease.

There are numerous ways how biobanks in all over the world carry consents of donors. Some are very liberal "presumed" consents, which allow storing biological material without a consent of a person when it cannot be received because of objective reasons, and later on allow to cancel this consent. Other consents allow to conduct only particular (marked in the consent) actions, e.g. for cancer research.

Lithuania is one out of few countries which do not have biobanks

Despite the evident benefit of biobanks to society, science and even economy (biobanks in foreign countries often encourage international pharmaceutical companies and researchers to establish laboratories for scientific researches which employ local scientists, also patent invented medicaments in those countries and collect taxes, etc.), Lithuanian lags behind, practically and in terms of regulations, the other EU Member States where biobanks operate for a long time. The advantages of biobanks are appreciated not only in the US or Western European countries but also in our neighbouring countries – Latvia and Estonia, which is particularly innovative in this area. Whereas Lithuania languidly solves this problem and therefore science in our country cannot use the potential in the field of biomedicine. Because of that patients cannot approach the most innovative methods of diagnostics and treatment and the objective to attract investments from the largest pharmaceutical companies remains declarative.

Amendment of the law is prepared

This situation could be changed by the working group of the Committee of Health Affairs of the Seimas, which prepares the draft of amendment to the Law on Ethics of Biomedical Research of the Republic of Lithuania in which it is sought to legitimise the activities of biobanks in Lithuania. The draft of the amendment defines rights and duties of biobanks, regulates the issues of collection, storage and handover of human biological samples to researchers, sets a strict protection of interests of a person who's biological material is being processed, includes a special protection for vulnerable persons, solves the problem of coding information about a person so that researchers could not get access to it and determines what part of information should be given to society or a concerned member of it.

Unfortunately, there are obstacles to this draft. Even though Lithuania declares innovative goals, it's not the first time when legal regulations encounter luddites, ultra-conservative provisions and bureaucracy. Legislators are afraid of various risks, hidden interests and worst scenarios (trafficking in human organs, etc.) and because of that it is offered to impose numerous pointless hurdles and bureaucratic control mechanisms on biobanks. Sadly, nobody realises that such regulations may impede the development of biomedical research in general and many doctors and young scholars could be lost because of that.

Development of biobanks in the EU once again discussed in the EU Council

Not only Lithuanian lawyers but also European institutions stress the need for clarity and flexibility in the area of biomedicine. In June a symposium of scholars, lawyers, legislators and representatives from public organisations from all over the world took place in the Council of Europe, Strasbourg. The participants of it were discussing the need to renew the 2006 Recommendation on research on biological materials of human origin. This symposium once again stressed the benefit of biobanks in the entire EU, discussed the possibilities of common biobanks' system, information exchange methods and possible problems.

It is obvious that Lithuania is in the initial status of creation of biobanks and has no possibilities to talk about joining the common EU information system which would be accessed by EU researchers. But observing achievements in other countries we have a chance to use their good practice and stop trying solving problems which have been already solved. For example, one of the biggest issues in Lithuania is the security of person's privacy. There are fears that humans' biological material (samples) could be related to other information such as medical history, personal number, etc. During the symposium attention has been paid to the issue that absolute anonymity does not exist, because a person could be identified after analysis and comparison of biological materials with the DNA of the person. Considering this, we should think hard whether the benefit that we get (e.g. new medicine and ways of treatment) does not counterbalance the possible theoretical risk of the disclosure of personal data. Very often people themselves publish their personal data, for example in the Facebook, so we should ask ourselves what would happen if some scholar would find out my identity.

From lawyers' point of view, nobody denies that personal privacy should be protected as much as it is possible, for example by coding the information transmitted to the scientist. But privacy should not be underestimated by giving up on other possibilities; there are two sides of a coin. Every person makes its own decision whether he/she wants to give samples to the biobank and evaluates every possible consequence. This opinion has been confirmed by one speaker of the symposium which represents an association of people ill with very rare diseases. She said that the majority of the members of the association would accept to give their biological material to a biobank without any confidentiality, i.e. without coding the information, only if it could increase the possibility for scientists to find the cure to their disease and save lives.

The future of Lithuania in the area of biomedical researches depends only on us

It would be very hard to find arguments why Lithuania should remain one of those few countries in the EU and all over the world which do not create new possibilities for science and do not establish biobanks.

Difficult questions had risen in other countries as well, but they had been solved or at least they are being solved. It does not mean that other countries do not respect personal privacy or are not afraid of other problems, but there is a big gap between us and other countries. For example, Malmö Microbiology biobank in Sweden collects samples since 1969, whereas we still discuss whether biobanks are needed at all. The vast majority of society have never heard about biobanks and don't know the benefits it may offer. Maybe in near future it will change because now at least we have discussions on this issue.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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