1. RESEARCH BIOBANKS IN
LITHUANIA:
A QUESTION OF ITS HISTORICAL,
SOCIAL, ETHICAL & LEGAL
PERCEPTION
Edvinas Meškys
PhD Candidate at Vilnius University Faculty of Law
Head of Legal Department at TEVA Baltics
Edvinas.meskys@lawin.lt

2. CONTENT
1. Introduction
2. A biobank – what is that?
3. A specific vs. traditional informed consent
4. Additional legal safeguards for biobank
participants (data protection, prohibition of discrimination,
right to get the results, right to revoke a consent, prohibition to get
financial gain from the body, etc.)
5. Conclusion
6. Questions
1

3. 1. INTRODUCTION
• Historical perspective – from moral habits to
laws
• Nowadays – from laws to society habits
A risk: a pollution of law with unnecessary and (or) non-
applicable laws.
2

4. 1.1. REGULATION OF BIOBANKS IN LITHUANIA
• Draft Law on the Law on Biobanks No. XIIP-
1522 as of 21-02-2014 (hereinafter – Biobanks’
law)
• Draft Law on the Law on Ethics of Biomedical
Research No. XIIP-2855 as of 24-03-2015
(hereinafter – LEBR)
3

5. 1.2. WHY LITHUANIA IS STILL A RED MARK
IN THE RESEARCH BIOBANKS’ MAP?
• History
• Lack of knowledge
• Unsolved legal
questions
4

6. 2. WHAT IS
A RESEARCH BIOBANK?
5

7. 2.1. A DEFINITION OF A BIOBANK
Possible four theoretical categories:
1. A direct definition of the biobank in
legislation (e.g., Norway);
2. An indirect definition of the
biobank in legislation (e.g., Estonian
gene bank; Latvian database of genes’
donors);
3. A definition related with the object
(e.g., “biolibraries”);
4. A definition related with the
possibility to identify the person
(e.g., Sweden’s one sample).
6

8. 2.2. A DEFINITION OF A BIOBANK
• Two major tendencies in regulation:
1.
2.
• EC’s recommendations of biobank’s criteria:
1. a quantity criterion;
2. a purpose criterion;
3. a relational criterion;
4. an organizational criterion.
Medical
information
Human biological
materials
Human biological
materials
Medical
information
7

9. 2.3. A DEFINITION OF A BIOBANK
• Tendencies are influenced by different law traditions as
well as constant change of the science, which has a direct
impact for a certain understanding of the biobank, e.g.:
(i) genetics is about the family;
(ii) treatment of separated body parts as the human.
• Conclusion: a biobank ≠ a constant
8

10. 2.4. THE DEFINITION OF “A BIOBANK”
BY LEBR
A biobank – a public legal entity, acting as a
budgetary or public institution, which has a health
care license to engage in activities involving:
• the management of human biological samples and
health information for the purposes set forth in
this law;
• the performance of biomedical research
(hereinafter - the license to engage in biobank
activities).
9

11. 2.5. THE DEFINITION OF “A BIOBANK”
BY BIOBANKS’ LAW
A biobank – health care institution’s, which founders or
shareholders are the State and University, department or:
• its established public institution,
• state budgetary research institution’s, licensed to provide
health care services, department;
• or budgetary forensic institution’s department,
which are licensed to manage human biological material
and (or) medical information for biomedical research
purposes under the laws of the Republic of Lithuania.
10

12. 3. A SPECIFIC CONSENT FOR
RESEARCH BIOBANK
vs.
A TRADITIONAL INFORMED CONSENT
FOR THE TREATMENT
11

13. 3.1. A TRADITIONAL INFORMED CONSENT
• A consent - a fundamental principal, a legal and ethical
ground for modern medicine and biomedical research
(e.g., Nuremberg code; Declaration of Helsinki; the Law on Ethics of
biomedical research of the Republic of Lithuania).
• A voluntary and wilful approval based on information
about:
(i) purpose of the research;
(ii) procedures;
(iii) possible risks and benefits.
12

14. 3.2. BALANCING BETWEEN AUTONOMY
AND SPECIFICITY
Specificity
Autonomy
13

15. 3.3. A TRADITIONAL INFORMED CONSENT
– NOT APPLICABLE FOR RESEARCH
BIOBANKS?
• Is historical ground for a consent in medicine also
justifiable and needed in research?
• Practical problems:
(i) an unknown purpose of a research;
(ii) an unknown period of storage;
(iii) unknown other purposes of usage of the samples and data;
(iv) lack of specific knowledge of the science.
14

16. 3.4. DIFFERENT CONSENT MODELS –
A COMMON AIM?
• Countries in which the biobanks are operated under
different consent models, such as a public agreement with
“opt-out” right, presumed consent, authorization of the supervisor,
broad, open consent or multi-layered, have the same legal and
ethical aim – to protect human rights and comply
with internationally acceptable bioethical
standards and ensure the potential of researches.
• Supervision by institutions and self-control bodies
instead of autonomy to give a specific consent.
15

17. 3.5. RECOMMENDATIONS ON THE CONSENT
IN LITHUANIA
• The combination of a few consent models together
with the granted right to revoke the consent at any
time.
• Importance of social sciences – various social studies
should be conducted analysing the trust level of the
society on biobanks, perception of certain degree of the
risks, economical situation, etc.
16

18. 3.6. THE ESSENCE OF CONSENTS IN
THE DRAFT LAWS OF THE REPUBLIC
OF LITHUANIA AS THE PRIMARY
RIGHT OF THE BIOBANK
PARTICIPANTS
17

19. 3.6.1. A CONSENT UNDER LEBR
Informed consent of the person for participation in the
activities of the biobank – a voluntary given, clear, conscious
written express of the will for the participation in the biomedical
research, signed by:
• the person itself, or
• another person, who is authorized under this law to act on behalf
of the person, or
• the spouse of the dead person, or if such person doesn’t exist;
• by a close relative,
to allow the management of the human biological sample (-es) and
health information, after clear and sufficient information, which
is needed in order to make the decision regarding such consent, is
provided. 18

20. 3.6.2. A CONSENT UNDER BIOBANKS’ LAW
Human’s informed consent for the biobank – voluntary, clear
and wilfully given written express of the will by:
• the person (i.e., biobank participant) or
• its lawful representative (in case of the person’s death – by its
spouse or close relatives)
for the biobank to get, manage and provide the human biomedical
material and (or) medical information, which will be used for the
biomedical researches,
when at the time when the consent is given the purposes of a
biomedical research are unknown or cannot be indicated for the
person.
19

21. 3.7. IS IT RIGHT TO CALL THE
CONSENT FOR BIOBANKS “INFORMED”?
20

22. 3.7.1. THE SCOPE OF PROVIDED INFO BY
LEBR
1) Info about biobank’s nature, possible benefits, discomfort
and risks;
2) Purposes and methods for the management of samples
and info and the fact that such purposes and methods
might be unknown due to the lack of development level of
the research or technology and other objective purposes;
3) Possibility to get the info about the use of samples and
info;
4) Confidentiality guaranties;
5) Right to revoke the consent.
21

23. 3.7.2. THE SCOPE OF PROVIDED INFO
BY BIOBANKS’ LAW
1) Purposes of the management of the samples and info and
the provision of the info for the third persons;
2) The essence of the consent;
3) Right to get the info from biobank about the use of
samples and info and the purposes of such use;
4) Right to revoke the consent;
5) Info about biobank’s right to collect info from person’s or
public health care institutions, public registers and other
places. Also about the right to prohibit such collection of
additional info or limit the scope of the information.
(is it a form of multi-layer consent?)
22

24. 3.7.3. LEGAL “TRAP” IN THE DRAFT LAWS
Art. 5 (4) of the Biobanks’ law indicates that:
“by signing the consent for biobank the person or its
representative confirms that he / she was properly
informed, understood the essence of the consent and
received written information about the use of the
biomaterials and medical information and agrees, that
the biobank would receive and manage the biomaterial and
(or) medical information, which will be used in biomedical
research”.
23

25. 4. ADDITIONAL LEGAL
SAFEGUARDS FOR BIOBANK
PARTICIPANS
24

26. 4.1. A NEED FOR ADDITIONAL LEGAL
SAFEGUARDS
• A consent – not the only safeguard needed.
• Development of genetics, informatics (“data
mining”), nanotechnologies and
microelectronics raises data protection and
possible genetic discrimination problems.
e.g., by the banks / insurance companies.
25

27. 4.2. PROTECTION OF DATA AND
PRIVACY AS THE ADDITIONAL
SAFEGUARD
26

28. 4.2.1. PROTECTION OF DATA AND
PRIVACY
• Article 2(1) of Law on Protection of Legal Protection
of Personal Data: “the personal data - is any information
relating to a person who can be identified directly or indirectly by
reference to certain data”.
• What about –
bio samples?
27

29. 4.2.2. A SPECIAL STATUS OF BIOMATERIAL
• Biomaterial operates as an USB or a hard drive from
which the genetic data could be extracted.
Example: DNA in a glass of water.
• S and Marper v. UK case – a tendency to broaden the data
protection and right to privacy.
• Implications:
(i) codification / anonymisation of data;
(ii) proper supervisory system.
28

30. 4.2.3. DATA PROTECTION BY BIOBANKS’
LAW
According to Art. 11:
• Biobank can store only medical info, which is needed
for the identification, description and research
qualification of the human biological material.
• Medical information is confidential and can be
provided only according to the laws, i.e., codified.
• It should be codified in such a way that the person’s
identity could not be verified.
• Both biosamples and medical info should be codified.
29

31. 4.2.4. DATA PROTECTION BY LEBR
• Art. 9 (1): “Health information, received when
performing biomedical research, which allows to identify
the person, is confidential… […]”.
• Art. 16 (3): “Health information in biobank is
confidential.”
Legal safeguard for informational discrimination –
“The confidentiality should be guaranteed by any natural or
legal persons, who are using the health information” (e.g.,
banks, insurance companies?).
30

32. 4.5. PROHIBITION OF DISCRIMINATION
AS THE ADDITIONAL SAFEGUARD
31

33. 4.5.1. PROHIBITION OF DISCRIMINATION
• Art. 4 of LEBR: “It is prohibited to discriminate the
person, limit its rights and legal interests:
(i) due to the fact that the biobank manages the biosamples
and info or the person refused to give the consent;
(ii) based on the biosamples and information in the biobank;
(iii) due to the fact that the person agrees or disagrees to
participate in the biomedical research;
(iv) based on the results of the biomedical research”.
• Biobanks’ law – no specific clauses on prohibition of
discrimination.
32

34. 4.6. PROTECTION OF VULNARABLE
PERSONS
AS THE ADDITIONAL SAFEGUARD
33

35. 4.6.1. PROTECTION OF VULNERABLE GROUPS
• LEBR:
1) Persons, who are not able to evaluate its interests due to their health condition;
2) Children;
3) Students, if their participation is related with studies;
4) Persons, who live in the social foster home institutions;
5) Soldiers, during their true military service;
6) Employees of the health care institutions, in which the biomedical research is performed;
7) Imprisoned persons;
8) Other persons – if decided by the Biomedical research ethics institutions.
• Biobanks’ law:
1) Persons, who are not able to evaluate its interests due to their health condition;
2) Persons, having psychic deceases, if they are able to give their wilful consent for the
biobank;
3) Minors;
4) Legally incompetent persons.
34

36. 4.7. THE RIGHT TO RECEIVE VALUABE
INFORMATION ABOUT THE HEALTH
AS THE ADDITIONAL SAFEGUARD
35

37. 4.7.1. THE RIGHT TO GET THE RESEARCH
RESULTS
Rules in Art. 17(6) of LEBR:
• Researcher should provide to the biobank important
information about the person’s health, which became known after
conducting the research on biosamples and info.
• Biobank evaluates the info according to special criterion.
• If the criterion are met, the biobank must provide it to the
biobank participant, its authorized representative or the doctor,
who treat the biobank participant.
Art. 17 of the Biobanks’ law - such right is not
granted by the law.
36

38. 4.7.2. PRACTICAL QUESTIONS RELATED
WITH OBLIGATIONS TO PROVIDE THE
RESULTS
• Is it justifiable to oblige the biobank to provide the
results, which are based on hypothetical limited-scope
research?
• Is there a possible civil responsibility?
• Who would be the responsible party for the damages:
the biobank and (or) researcher and (or) the customer
of the research and (or) the doctor?
37

39. 4.8. THE RIGHT TO REVOKE THE
CONSENT
AS THE ADDITIONAL SAFEGUARD
38

40. 4.8.1. THE RIGHT TO REVOKE THE CONSENT
Art. 8(10) of LEBR:
• Biobank grants a right for the person (its
representative), or the spouse of the dead person, or a
close relative, a free and easily manageable right by
the written consent to revoke the consent.
• After receiving the request:
– the biobank cannot manage the samples and
information, and
– in case it is provided for the research – it cannot be used
for research and should be immediately destroyed.
Biobank participant is informed about it.
• The results of the research shall not be destroyed. 39

41. 4.8.2. THE RIGHT TO REVOKE THE CONSENT
Art. 6 of Biobanks’ law:
• The person should be granted a clear, free and easily
manageable right to revoke the consent.
• Biological material and medical information shall be
destroyed within 1 month.
• If destruction is not possible due to technological
matters, the samples can be stored in biobank max. 6
months, but such samples and info cannot be given for
the research.
• The results of the research and the advanced therapy
pharmaceuticals should not be destroyed. 40

42. 4.9. PROHIBITION TO RECEIVE
FINANCIAL BENEFITS FROM
BIOSAMPLES
41

43. 4.9.1. PROHIBITION TO GET FINANCIAL
BENEFITS FROM THE BODY IN LAWS
• According to Art. 2.25 (5) of the Civil Code “Human
body, its parts or organs and tissues cannot be a matter of
commercial agreements. Such agreements are void”.
• Art. 21 of Oviedo convention “human body and its parts
cannot be a source for financial benefit”.
• Art. 3(2c) of EU Charter on Fundamental Rights “in the
fields of medicine and biology, the following must be respected in
particular […] the prohibition on making the human body and
its parts as such a source of financial gain”.
42

44. 4.9.2. PROHIBITION OF FINANCIAL GAIN
IN THE DRAFT LAWS
• LEBR: financial gain is not prohibited directly.
• Art. 3(3) of Biobanks’ law: “The biobanks shall
perform its activities exclusively based on non-commercial
basis. The biomaterial and (or) medical information
stored in the biobank cannot be pledged, taken as a
guarantee for the debenture or passed to the creditors”.
43

45. 5. CONCLUSIONS
44

46. 5.1. LEGAL AND / OR MORAL REGULATION?
• Social, historical and economical studies – as the base of
regulation.
• Legal norms – as the base for protection and balancing of
rights and interests.
• Principles such as priority of individual vs. the interests of the
society and science, autonomy, justice, openness to the public,
transparency shall be combined together in each case.
• Proper supervisory and implementation of legal norms and
principles by special institutions.
45

47. 46

48. Thank You!
47