In Germany there are no specific legal provisions on the exchange of human samples for research purposes nor specific biobank law. However, we can find in the Federal law (mainly in the Federal Data Protection Act) and some opinions from the German National Ethics Council, regulation and non binding provisions concerning the use and the handling of human biological material and linked data for research purpose including issues related to their international exchange.

In addition, Federated States, Länder, have general protection laws and guidelines enforceable in their own territory to the establishments storing or using human biological materials or biobanks for scientific research purposes. The Länder have also their own data protection laws which are applicable. They tend to be identical or at least very similar to the federal law but in some cases they differ. These laws have to be respected.

In the following parts we are only analysing Federal laws and non-binding opinions related to the matter.

HUMAN SAMPLES

 

• German National Ethics Council, “Nationaler Ethikrat” (NE): Opinion on Human Biobanks for Research; Humanbiobanken für die Forschung, available in German and in English (15/06/2010)

 

Purpose and scope

 

The purpose of the opinion is to provide a suitable legal framework for the interests and rights of personality of the donors, to achieve more legal certainty for biobank research and, at the same time, to facilitate research.

The subject of this Opinion is human biobanks for scientific research (referred to below as biobanks). These are collections of human biological material which is linked to health-related and other information about the donors. Biobanks which store human biological material such as umbilical cord blood for therapeutic purposes are not the subject of this Opinion.

In its Opinion, the German Ethics Council proposes a “five-pillar concept” for biobank regulation.
It includes recommendations on introducing a professional secrecy for biobanks, on defining permissible use, on involving ethics commissions, on quality assurance and on transparency (the “five-pillars”).

The specific issue of the legal framework for international activities of German research biobanks is tackled. 

This Opinion comes in addition to existing Opinion on biobanks of the German National Ethics Council.

 

• German National Ethics Council, “Nationaler Ethikrat” (NE): Opinion on Biobanks for Research; Biobanken für die Forschung, available in English (17/03/2004)

 

Purpose and scope

 

“For the purposes of this Opinion, biobanks are defined as collections of samples of human bodily substances that are or can be associated with personal data and information on their donors. Examples of bodily substances are cells, tissue and blood, as well as DNA as the physical medium of genetic information.

Depending on the purpose of a given biobank, both genetic information on persons and health- and lifestyle-related information on these persons may be associated with the samples. It is this association that makes the sample collections important. The particularity of biobanks, which are the subject of this Opinion, lies in their twofold character, as collections of both samples and data.

This opinion will only deal with biobanks established or used for medical research. Are concerned human embryonic stem cells collections and foetal tissues collection. This opinion is not analysing their particularities in so far as their obtainment and their use are subject to specific regulations which remains unchanged. Biobanks concerned here may be biobanks for diagnosis or therapeutical purposes only if it is planned, contrary to their initial function, to use them in totality or partially for medical research. Biobanks exclusively dedicated to clinical uses and forensic biobanks are not covered by this Opinion.”

 

• Joint document of National Consultative Bioethics Committee (France) and Nationaler Ethikrat (Germany) concerning Ethical problems raised by the collected biological material and associated information data : “biobanks” , “biolibraries”, N°77,  March 20, 2003; Ethische Probleme aufgeworfen durch die gesammelten biologischen materialien und informationen daten verbunden: “biobanken”, biolibraries”. 

 

ASSOCIATED DATA

 

• Federal Data Protection Act of 20^th December 1990 as modified in 2009; Bundesdatenschutzgesetz (BDSG), available in English

 

Purpose and scope

 

The definition of personal data includes human biological material’s linked data as “health data” and “special types of personal data”. A specific protection of these kinds of data is laid down by the Act. However the biological material itself is not included in its scope.

 

 “The purpose of this Act is to protect the individual against his right to privacy being impaired through the handling of his personal data” (Section 1(1)).

This Act applies to public and private bodies implementing research as medical research and to the international data transfer for research purposes.

This Act shall apply to the collection, processing and use of personal data by

1. public bodies of the Federation,
2. public bodies of the Länder, where data protection is not covered by Land legislation and where the Länder

a) execute federal law, or
b) act as judiciary bodies and administrative matters are not involved,

3. private bodies that collect data for use in data processing systems, or use such systems to process or use data, or collect data in or from non-automated filing systems, or use such systems to process or use data,

unless the data are collected, processed or used solely for personal or domestic activities (Section 1(2)).

Where other federal laws apply to personal data [...], they shall take precedence over the provisions of this Act. The obligation to abide by legal obligations of secrecy or professional or special official secrecy not based on law shall remain unaffected (Section 1(3)).

The provisions of this Act shall take precedence over those of the Administrative Procedures Act where personal data are processed in ascertaining the facts (section 1(4)).

This Act shall not apply in so far as a controller located in another European Union (EU) Member State or another state party to the Agreement on the European Economic Area (EEA) collects, processes or uses personal data inside the country, except where such collection, processing or use is carried out by a branch inside the country. This Act shall apply in so far as a controller not located in a European Union Member State or other state party to the Agreement on the European Economic Area collects, processes or uses personal data inside the country. In so far as the controller is to be named under this Act, information on representatives located inside the country shall also be furnished. Sentences 2 and 3 shall not apply where data storage media are used solely for the purpose of transit through the country. Section 38 (1) first sentence shall remain unaffected. (Section 1(5)).

Data transfers include the transfer of personal data to bodies

1. in other European Union Member States,
2. in other states parties to the Agreement on the European Economic Area, or
3. of the institutions of the European Communities
(See section 4b(1))
4. in third countries (non EU Members / EEA)
(See section 4c)

 The German rules to export (updated on 2011-07-28)

DEFINITIONS

According to the German National Ethics Council Opinion on Biobanks for Research of 2004

“Biobanks” are defined as collections of samples of human bodily substances that are or will be associated with personal data and information on the donors. Examples of bodily substances are cells, tissue and blood, as well as DNA as the physical medium of genetic information. Depending on the purpose of a given biobank information on the persons concerned, genetic information as well as health- and lifestyle-related information, may be associated with the samples. It is this association that makes the sample collections important. The particularity of the biobanks, which are the subject of this Opinion, lies in their twofold character, as collections of both samples and data. Are not considered as biobank in this definition a collection containing only personal data, obtained from bodily materials and recorded, as, for example, the results of laboratories’ analyses performed on blood or genetic analyses results. There are pure data bank that should be assessed complying to the data protection rules taking into account particular requirements for genetic data processing.  

 

According to the German National Ethics Council Opinion on Human Biobanks for Research of 2010

“Biobanks”: The term human biobanks usually refers to collections of samples of human body substances (e.g. tissue, blood, DNA) which are linked to personal data and socio-demographic information about the donors of the material. They have a dual nature as collections of samples and data. Most currently existing biobanks are research biobanks, that is, systems which collect samples and data of human origin and either use these for their own research or make them available to third parties for research purposes. Their purpose is the use of the collection for scientific research. They are designed to be used for a variety of research purposes, some of which will only be apparent in the future. They play a central role in research on the causes and mechanisms of a large number of illnesses and their treatment. There are also biobanks containing material which is used for diagnostic and therapeutic purposes. Classic examples of this are pathology departments, blood donor services or umbilical cord blood banks.

 

Every collection should be the subject of the statutory provisions for biobanks proposed below if it satisfies the following three criteria:

a) It contains genetic material originating from humans with related data.

b) Its samples are electronically linked to personal information (possibly pseudonymized) and further information, in particular relating to health.

c) Its samples and data are collected, preserved or used for purposes of scientific research.

 

According to the German Federal Data Protection Act of 1990

“Processing” shall mean the recording, alteration, transfer, blocking and erasure of personal data.

 

“Special categories of personal data” means information on a person’s racial and ethnic origin, political opinions, religious or philosophical convictions, union member-ship, health or sex life.

 

“Data Controller” shall mean any person or body which collects, processes or uses personal data on his, her or its own behalf, or which commissions others to do the same.

 

“Recipient”  shall mean any person or body to whom or which data are disclosed.

 

“Third party” shall mean any person or body other than the controller. Third parties shall not mean the data subject or persons or bodies collecting, processing or using personal data in Germany, in another European Union Member State or another state party to the Agreement on the European Economic Area.

PROCEDURES

Who can export?

 

 There is no specific mention defining the exporter of human biological material for research uses in the German law. The National Ethics Council only defines research biobanks using, and transferring, human biological materials and associated data which may be public legal entities, as university’s institute, or private companies, as for example pharmaceutical companies (German National Ethics Council, “Nationaler Ethikrat” (NE) Opinion on Biobanks for Research of 2004, Summary of the regulatory proposals).

The Federal Data Protection Act allows public and private bodies to collect and use, including transfer, personal sensitive data for research purposes under the responsibility of the data controller (Federal Data Protection Act Part II, and III).

Authorisations

No specific licence is required

The establishment does not need to detain a specific legal license to use and export human biological material and/or associated data for research over and above the generally applicable requirements of registration and approval. Creation of such specific legal license is not planned in Federal laws but this possibility is discussed in connection with large-scale biobanks. (NE Opinion on Biobanks for Research of 2004, regulatory proposal 15 and section D point 6.3.1.).

Ethical approval of the research

Prior to the conduct of a research project involving the use of biobank samples and data, it should be necessary for the approval of an ethics committee to be obtained where

• bodily substances are to be collected from a donor’s body for research purposes;
• the project calls for the linking of samples to personalized data;
• bodily substances in personalized or pseudonymized form are to be transferred to external researchers;
• existing biobanks are to be transferred in toto to third parties with the inclusion of personalized donor data;
• exceptional situations are to be invoked (see NE Opinion on Biobanks for Research of 2004, regulatory proposal 4)
   

This approval would be given after a risk assessment, a legal control and an ethical review of the project (NE Opinion on Human Biobanks for Research of 2010, 4.2.3; II.3; NE Opinion on Biobanks for Research of 2004, 6.3.3, regulatory proposals 17). The ethics commissions which have local competence for a biobank, the ethics commissions which are competent for the researchers involved should also become involved in consulting on biobank projects (NE Opinion on Human Biobanks for Research of 2010, 4.2.3). Biobanks affiliated with large hospitals or universities may also be subject to ethics review boards of these institutions.
 

An ethics commission does not need to be involved if samples and data are totally anonymised AND it is not planned to re-identify the donor in the research (NE Opinion on Biobanks for Research of 2004, regulatory proposals 18 and section D, 6.3.3).

Where biobank secrecy applies, it is not necessary to provide for the approval of an ethics commission for every individual research project which is to work with biobank samples or data. Biobank secrecy averts a large proportion of the endangerment of donors’ personality rights that is entailed by biobank research. It protects the samples and data against non-authorised external access and prevents them being used for purposes other than research. Biobank secrecy can be introduced only by statute (NE opinion on Human Biobanks for Research of 2010, 4.2.3; II.3).

The German National Ethics Council (NE) only gives advice, it is not involved here.

Registries

Transparency of aims and procedures of a biobank should be ensured.

Public registry providing complete information on biobanks which are not restricted in their purposes and duration

Biobanks which are not restricted in purpose and duration have further requirements, for transparency. This includes in particular complete documentation and regular publication of the activities of the biobank, and the setting up of a publicly accessible biobank registry. The documentation includes, among others, information on the regulations on the collection, use and transfer of samples and data whith which the biobank shall respect and a clear, generally intelligible and up-to-date account of the purposes for which samples and data have been used or transferred (NE, Opinion on Human Biobanks for Research of 2010, Recommendation II.5; the content of the public registry is further described in the same document, point 4.2.5.).

German Biobanks Registry

A Federal Biobank Register available online for Germany. This registering is not a legal requirement but can answer to a need for transparency; biobanks and individuals having access to useful information.

A further important tool is the CRIP platform at the Fraunhofer Gesellschaft. The Ethics Policies of CRIP are often referred to as a benchmark in Germany although CRIP itself is not subject to data protection regulations.

Contract

The export operation shall be formalised in a written cooperation agreement between partners. A Material Transfer Agreement (MTA) could be used. Find more practical information concerning research biobanks on the TMF website and in the “BMB-EUCoop” documents. 

Samples such as blood or tissue fall under property law in Germany. Thus, for the export, the contract needs to address both the obligation to transfer the samples and the actual transfer itself. Clinical data which are attached to the samples do not fall under property law, therefore the legal construct needs to be carefully developed.

 

The standard contractual clauses developed by the European Union concerning international data transfers could also be used in relation with the research purposes and methods (available here).

Binding corporate rules (BRCs) could also be relevant for such exchanges.

 

The limitation of use to a specific purpose must be structured by statute or contract in such a way that not only the biobank operators are bound by it, but also all persons who have access to the samples and data. The terms of use, together with the consent, should be directly connected to the data, so that the relevant information is available every time the biobank is used, and they should automatically be transferred together with biobanks or individual records or samples which are transferred to other institutions (NE Opinion on Human Biobanks for Research of 2010, II.2).

Informed consent

 

The essential requirement for the use of the samples and data in biobanks should be the donors’ consent (NE Opinion on Human Biobanks for Research of 2010, II.2). However, all uses of human samples and associated personal data in research are not mandatorily subject to the consent of the individual concerned (e.g. anonymous data). This is qualified case-by-case according to a risk assessment.

The transfer of samples and related data should be clearly documented (NE Opinion on Biobanks for Research of 2004, regulatory proposal 7; section D, 2.3; 2.4; 3; 4; NE Opinion on Human Biobanks for Research of 2010, points 2.5., 4.2.2.).

Consent should include, among others, information about the “extent of, and conditions for, the possible transfer of samples and data, perhaps abroad, in Europe or outside Europe; the form of data storage and combination; anonymisation or pseudonymisation of samples and data” (NE Opinion on Biobanks for Research of 2004, regulatory proposal 11; NE Opinion on Human Biobanks for Research of 2010, points 4.2.2.). Where the identity of cooperating partners is known at the time of establishment of a biobank, subjects should be informed of this. However, it should also be possible to consent to the transfer of samples and data to as yet unknown researchers. The same applies to transfers to the privately funded research sector (NE Opinion on Biobanks for Research of 2004, point 2.3).

Freely given informed consent from the data subject is a requirement to use identifiable personal data in research. Conditions and information process are laid down in the Federal Data Protection Act and enforceable both to public and private bodies (See Federal Data Protection Act Section 4, as well as specific rules laid down for transfer in section 4b, 15, 16, 29, 30 and 40 according to your situation).

Where special categories of personal data (see definitions above) are used the consent must specifically refer to these data (Federal Data Protection Act Section 4a al.3).

Consent shall be given in writing unless special circumstances warrant any other form. If consent is to be given together with other written declarations, the declaration of consent concerning personal sensitive data shall be made distinguishable in its appearance (Federal Data Protection Act, section 4a al. 1; and for a specification of “special circumstances” in the field of scientific research see the Federal Data Protection Act, section 4a al. 2).

In certain cases, consent can be given by the legal representative of the donor incapable or deceased (NE Opinion on Biobanks for Research of 2004, regulatory proposal 25; section D, point 9).

Consent to use samples and data in research can be more or less large but reasonable in its scope and duration (e.g. NE Opinion on Biobanks for Research of 2004, regulatory proposal 6, 20, section D, point 2.2).

The partners must act in accordance with the terms of the given consent (e.g. limitations on storage and use purposes).

Cession of a biobank, associated data and identification codes should be subject to a specific mention on the consent form approved by the donor. A non-specific consent by a donor to transfer should, as a rule, be interpreted as meaning that samples and data may be transferred only to an equivalent institution (NE Opinion on Biobanks for Research of 2004, regulatory proposals 7, 8; section D, point 2.4).

The donor has the right to withdraw his/her consent. It should be possible to agree with the donors that in the case of a revocation of consent, samples and data must only be anonymised, not destroyed; however, it must be clearly explained to the donor in this circumstance that in many cases an absolutely watertight anonymisation is not possible (NE Opinion on Human Biobanks for Research of 2010, 4.2.2.). Donor’s rights of withdrawal shall be guaranteed whenever samples and data are transferred. Withdrawal can relate only to identifiable or not yet anonymised samples and data (NE Opinion on Biobanks for Research, 2004, section D, point 2.3 and 6.1).

Informed consent for secondary use of the biological sample and linked data

 

The wish of the donor expressed in the original informed consent gathered at the time of the collection of the samples and related data must always be respected (NE Opinion on Biobanks for Research of 2004, section D, point 1.).

 

The issue of the secondary uses of human biological material and related data remains discussed (NE Opinion on Human Biobanks for Research of 2010, 2.2.) even if several possibilities are planned through non-binding recommendations (See the provisions in the NE Opinion on Biobanks for Research of 2004, section D, point 1 and in NE Opinion on Human Biobanks for Research of 2010, point 3.).

 

However, the Data Protection Act allows public bodies (Data Protection Act, section 14) and private bodies (Data Protection Act, section 28 point 4) to use personal data for other purpose than those expressed in the original consent form without seeking new specific donor's consent where:

• This is necessary for the conduct of scientific research,
• Scientific interest in conduct of the research project substantially outweighs the interest of the data subject in excluding the change of purpose and
• The research purpose cannot be attained by other means or can be attained thus only with disproportionate effort.

All the conditions must be met to justify the use of data for secondary purposes without the consent of the data subject. Alternatively the secondary use is justified if it is foreseen in the law. Requirements for an ethical approval from a competent Ethics Commission should be satisfied. 

 

In view of the purpose of use of biobank samples and data which cannot be specified in detail in advance, the donors must have the possibility for the complete duration of use of the samples and data to understand the procedures of collection, storage and transfer, and also the research purposes (including secondary research) for which individual samples and data are used (NE Opinion on Human Biobanks for Research of 2010, point 4.2.5.). 

Data transfer requirements

 

The data transfer for research must be necessary, legitimate and can be performed with public or private bodies. Legal requirements are varying according to the public or private statute of the data contoller.

 

Notification

Prior to putting automated processing procedures into operation the exporter has to notify such procedures, including data transfer, to the competent supervisory authority (for private controllers), to the competent data protection office of Länder or to the Federal Commissioner for Data Protection and Freedom of Information (for federal, public controllers). Obligatory notification shall not apply if the controller has appointed a data protection official (Federal Data Protection Act, section 4d) or when data are anonymised.

 

The notification will trigger a prior checking carried out in particular if
1. special categories of personal data (Section 3 (9)) are to be processed, or
2. the processing of personal data is intended to assess the data subject’s personality and his/her abilities, performance or behaviour,
unless a statutory obligation applies, the data subject’s consent has been given, or the collection, processing or use is needed to create, carry out or terminate a legal obligation or quasi-legal obligation with the data subject (Federal Data Protection Act, section 4d(5)).

 

To notify this data transfer procedure the information mentioned in the Federal Data Protection Act, section 4e, must to be provided to the competent authority:

• Name or title and adress of the controller,
• Owners, managing boards, managing directors or other lawfully or constitutionally appointed managers and the persons placed in charge of data processing,
• Purposes of collecting, processing or using data,
• A description of the groups of data subjects and the appurtenant data or categories of data,
• Recipients or categories of recipients to whom the data may be transferred,
• Standard periods for the erasure data,
• Any planned data transfer in third states,
• A general description enabling preliminary assessment as to whether the measures in accordance to Section 9 to guarantee the safety of processing are adequate.

 

Any amendment of declared elements must to be reported.

 

Data protection

It is necessary to ensure the donor’s protection internationally concerning the samples and their linked data (NE Opinion on Human Biobanks for Research of 2010, 4.3.). Health and genetic data are sensitive data particularly protected under the Federal Data Protection Act and Ethical standards as “special categories of personal data”.

 

As a principle, associated data should leave the biobank in anonymised or coded (pseudonymised/aliased) form. External partner should not have access to the code. Personal data such as names, birth dates and addresses should not be passed on to third parties, except where this has been authorised for the purpose of the research (NE Opinion on Biobanks research, section D, point 2.3 and 6.2).

 

Personal data transferred shall be processed or used by the third party only for the purpose for which they were consented and transferred (Federal Data Protection Act, section 39, 40; NE Opinion on Biobanks for Research of 2004, section D, point 2.3).

 

It is an obligation to maintain secrecy for all partners involved in the research project. The duty of discretion concerning personal data should be specifically imposed by statutory or contractual provisions (NE Opinion on Biobanks for Research of 2004, regulatory proposal 19; section D, 6.4.). The medical secrecy regarding biobank should restrict the processing and transmission of samples and related data for the duration of their existence to the purposes of scientific research and guarantee that they are inaccessible to all non-research third-parties. In its Opinion of 2010, the Council presents the content of biobank secrecy and a number of proposals for safeguarding medical secrecy regarding biobank when samples and data are exchanged with partners abroad (NE Opinion on Human Biobanks for Research, 2010, points 4.2.1.; 4.3. and III).

 

In addition, the data subject detains “inalienable rights” of access, correction, erasure, blocking and request for information concerning his/her personal data (Federal Data Protection Act, section 6).

 

Personal data related to a human biological sample can be exported to other EU’s countries and to non-EU’s countries.

 

DATA TRANSFER INSIDE THE EU / EEA

 

EU Member States are deemed as sufficiently protective of data subject's privacy. Personal data exchanges with these countries are free under the respect of the EU Data protection Directive 95/46/EC.

 

DATA TRANSFER OUTSIDE THE EU / EEA

 

Non EU’s countries must have an adequate level of personal data protection. External recipient shall be submitted to adequate standards of privacy protection and quality assurance. An assessment of this level of protection shall be considered regarding the specific nature of biological material and linked data transferred (Federal Data Protection Act, section 4b, point 2, 3 and 4c).

 

Where the level of protection abroad is not comparable to that in Germany, the transfer shall be lawful under the condition displayed in the article 4c of the Federal Data Protection Act, and with the authorisation of the competent authority.

Furthermore, in such a case, the cooperation with researchers or with research institutions abroad should be carried out only subject to the following conditions (NE Opinion on Human Biobanks for Research of 2010, 4.3, III.2):

a) There should be a strict separation of biobank materials and data on the one hand and reference lists which can be used to allocate the pseudonymized samples and data to the relevant donors on the other hand. The reference lists, or the connections to personal data contained in them, should not be permitted to be transferred abroad.

b) It should be specified that the persons who deal with samples and data should before receiving them at all events agree to observe biobank secrecy, provided this is permitted by their respective legal systems. If it is not possible for them to enter into this agreement, the biobank must examine whether in the individual case transfer should be refused on account of danger to donor protection.

c) Where a State has access, biobank secrecy should be protected against differences in legal systems in such a way that information obtained by foreign access to samples and data is at all events inadmissible as evidence in criminal proceedings in Germany where there would have been no lawful right of access to the samples and data in Germany.

Internal control

An appointment in writing of an internal person responsible for the data transfer (a data controller) is required.

Where necessary under the Data Protection Act, section 4f, the research establishment shall also appoint in writing a data official which is responsible for the compliance to the Data Protection Act. The data official is independent and has legal duties (Federal Data Act, Section 4g). Furthermore he has to keep a register of the transfer operations and the data processing systems used. The data controller and the data official must cooperate referring to the law (Data Protection Act, section 4g(2)).

 

The responsible person is the data transfer superintendent of the transfer security. Therefore this person:

• Shall inform the body to which data are transferred of the purpose of the transfer (Federal Data Protection Act, section 4b point 6),
• Shall be subject to the obligation of confidentiality (Federal Data Protection Act Section 39; NE Opinion on Human Biobanks for Research of 2010, II.1; NE Opinion on Biobanks research of 2004, regulatory proposals 19 and section D, point 6.4),
• Shall use (together with foreign partner) operational security system for data processing. The access of data must be limited (Data Protection Act, section 9 and Annex, section 42a; NE Opinion on research biobanks, point 11) but the donor has the right to access to his own data,
• Must ensure that the organisational system used provides for separate storage and administration of the code and of the encrypted data as regards to the authorised research purposes (Data Protection Act, section 40 and NE Opinion on Biobanks for Research of 2004, point 6.2). 

 

After the transfer of the human biological material and linked data to third party the exporter is in charge of the correction of incorrect data, the blocking of disputed data and the erasure or blocking of data due to inadmissible storage. These elements shall be notified to the bodies to which these data are transmitted for storage within the framework of regular data transfer (Federal Data Protection Act, Section 20, point 8).

 

The internal control required by law is supplemented by external supervision.

External supervision

This external control is exercised in the public sector by competent data protection office(s) (for federal public research bodies by the Federal Data Commissioner, Der Bundesbeauftragte für den Datenschutz und die Informationsfreiheit)(Federal Data Protection Act, section 24) and in the private sector by special supervisory authorities (Federal Data Protection Act, section 38).

 

Each of the Länder has its own data protection office. Thus, supervision depends on the seat of the organisation/ institution where the data are processed / stored. In the case of collaborative research projects different supervisory authorities may be in charge. Each private entity needs to ensure its own compliance with the applicable data protection law.

 

Find interlocutor to register and monitor your data transfer operation according with your own status (public/private).

 

For more information on the German data protection rules you can consult the legal pathways website. 

Transport and exchange biosafety

Exporter is responsible for the transport security. He has to respect International, European and German transport regulations concerning biological material.

This exporter’s responsibility concerns the packaging and the labelling of the container in order to allow to avoid any predicable biological risks and ensure traceability. These elements should be checked during export controls at the border crossing.

More information on the transport of biological material.

Biobanks raise ethical and legal questions which extend from the protection of individual rights to the global control of research infrastructures. The Gendiagnostikgesetz [Gene Diagnostics Act], which entered into force in February 2010, does not deal with these questions. To date research biobanks are only governed by general legal provisions. In view of the growing challenges, the German Ethics Council considers it is necessary to create specific provisions for human biobanks.

 

There is a lack of legal instruments regulating research biobanks activity, this including human biological material exchange, export or import. Members of the German National Ethics Council are convinced that these questions need clear ethical and legal regulation by law. They propose the issue to be addressed by German policymakers (See the opinion adopted in June 2010 concerning human biobanks for research  dealing with the main principles that should form a starting point for new law[s]).