sou · GYB381 · 2010-11-29 00:00:00 — The Inquiry proposes that the Biobanks Act is to apply to identifiable tissue samples collected from donors or deceased persons stored by biobanks covered by the Act. The provisions of the Biobanks Act regarding self- determination cannot be applied when tissue samples are taken abroad. Such samples are, however, subject to the provisions of the Act when they are collected for biobanks in . According to the Biobanks Act, tissue samples taken within the framework of one principals activities but collected for another principals biobank are to be regarded as belonging to the latter principal. For example, tissue samples collected within the care system but intended for use in clinical trials at a pharmaceuticals company are regarded as having been collected for the companys biobank and not for the care systems biobank. This means that such samples are not to be regarded as having been released from the care systems biobank. The Inquiry proposes that the Biobanks Act is not to apply to tissue samples that have only been stored while awaiting analysis. The Act is, however, to apply if samples are stored longer than six months of being taken or if they are stored or used for any purpose other than that for which they were taken. The proposed amendments mean that the exception for routine samples is expanded to apply beyond the care system. The exception period begins when the sample is taken and not when the analysis is made, so it will not be possible to store samples for an extended period prior to analysis. At the same time, the time limit is extended from two to six months. The Inquiry proposes that the Biobanks Act is not to apply if a tissue sample has been processed so that its original properties have been changed to a considerable degree. In vitro fertilisation of a human ovum or similar measures is not to mean that the Biobanks Act no longer applies to the ovum. is normal processing of tissue samples at the biobank to result in the Act ceasing to be applicable. It is only when the tissue sample has been processed so that it constitutes a product or a research outcome that it may no longer be appropriate to view it as a tissue sample. For example, a tissue sample that is included in a pharmaceutical or technology product must be regarded as having been changed to such an extent that the Biobanks Act cannot be applicable. The Inquiry considers that the of an identifiable cell line from a fertilised human ovum or from an ovum that has been the object of somatic cell nucleus transfer does not in itself mean that the original properties have been changed to a considerable degree. The Act is thus to apply to such cell lines. The Inquiry proposes that the Biobanks Act is to apply to tissue samples that are collected and stored for transfusion, transplantation, insemination, in vitro fertilisation or for the production of pharmaceutical or technology products only if they are stored longer than six months of being taken or if they are stored or used for any other purpose than that for which they were taken. The Biobanks Act will not apply to blood samples or other tissue samples from a donor when the samples are only stored for quality when used in connection with transfusions or transplantation. This concerns samples that are stored to protect the safety of the recipient. The Inquiry proposes that the Genetic Integrity Act be amended to give donors of sperm for insemination the same privacy protection as donors of sperm for in vitro fertilisation. The Inquiry proposes only minor amendments to the provisions in the Biobanks Act concerning various purposes. concerning clinical trials is to be included in that concerning research. Transfusion and transplantation, as well as production of pharmaceuticals and technology products, are to be listed as individual purposes. The Inquiry proposes differentiation of the regulations for consent in the Biobanks Act. Under the current Act, the consent of the donor to collect and store tissue samples must be obtained for all types of samples. Under the Inquirys proposal, it will be possible to collect and store tissue samples for use in the care and treatment of the donor for certain limited purposes, provided that the donor does not object to this. A sample may not be stored against the donors will. Apart from care and treatment, tissue samples may be stored for quality and development work within the framework of activities as well as for training that is conducted in conjunction with the care system. Furthermore, tissue samples may be stored for later use in research. The donor will be given the opportunity to specifically object to the storage of tissue samples for these purposes. For other purposes, express consent is required, especially when tissue samples are collected for research, including clinical trials. In such cases, the provisions of the Act concerning the involving Humans (2003:460, also known as the Act) and the Act (1992:859) will apply. When samples that have been stored for later use in research are considered for use in a research project, an ethical review board will decide which requirements are to apply regarding information and consent for use of the tissue samples (Section 15 of the Act). Our proposal calls for the collector of tissue samples to be required to inform the donor of the right to self-determination, the reason for collecting and storing the tissue sample and the purpose of the biobank. Since the Inquiry now proposes that samples in many cases may be collected as long as the donor does not object, it is particularly important to ensure that adequate information is always provided. Adequate information will provide the donor with the necessary knowledge to decide whether he or she wants to agree or disagree to the sample being collected and stored in the biobank. Regarding minors, the legal guardian will, as is the case today, have the right to decide whether a tissue sample is collected and stored in a biobank until the minor has reached an age and maturity where he or she can make a decision on their own. The Inquiry proposes, however, that a tissue sample from a minor may be collected and stored in a biobank against the wishes of the legal guardian if a clear risk of damage to the health of the minor would otherwise arise. In such cases, the tissue sample may only be used for the care and treatment of the minor. The Inquiry proposes that a tissue sample may be collected and stored in a biobank even if the donor, due to illness, mental disturbance, weakened state of health or similar circumstances, cannot take a decision on the issue (lacks decision-making capacity). As a general rule, such samples may only be used for purposes that do not require the express consent of the donor. Swedish law does not yet contain an arrangement regarding the representation of those who lack decision-making capacity that is appropriate for use in the Biobanks Act. Those who lack decision- making capacity must nevertheless have access to good quality care on the same terms as everyone else. Such tissue samples may, in the Inquirys view, also be stored for future research, since research into people with dementia-related illnesses, for example, would otherwise suffer considerably. The Inquiry proposes that the Biobanks Act makes clear that special provisions in other acts concerning the taking of tissue samples, with or without consent that differ from what is stated in the Biobanks Act are also to apply to the collection and storage of the samples. A tissue sample that was taken with the support of such a provision may be stored and used for the purpose for which it was taken under the conditions that apply to the taking of the sample. This concerns such matters as communicable disease regulations and provisions on compulsory mental care. Under these regulations, samples may be taken regardless of the donors position. In addition, there are regulations with stricter or different requirements concerning consent than those of the Biobanks Act, such as Chapters 5–7 of the Genetic Integrity Act. Under these regulations on assisted fertilisation and other issues, consent is also required from the individual in the couple being treated who is not These regulations, too, are to be applied rather than the provisions of the Biobanks Act. In principle, however, tissue samples may not be stored or used for any new purpose without adhering to the provisions of the Biobanks Act. The Inquiry proposes that a tissue sample may be used for another purpose than that for which it was previously stored only if the provisions of the Biobanks Act concerning collection and storage are followed for the new purpose. Concerning new purposes for tissue samples from deceased persons, close relatives of the deceased are to be given the opportunity to object to the purpose. The Inquiry proposes that the donor can, at any time, decide that a collected tissue sample is to be destroyed or only used for certain purposes. The proposal gives the donor the unconditional right to have the tissue sample destroyed. Consent can also be withdrawn under the current Act, but then the biobank has the option of de- identifying the sample rather than destroying it. The tissue sample is to be destroyed as soon as is possible after notification is given, rather than immediately, which is the requirement of the current text of the Act. The Inquiry proposes that a tissue sample that is stored in a biobank may be de-identified only if the provisions of the Biobanks Act concerning collection and storage are followed with regard to de-identification. However, this is not to apply when the tissue sample is from a deceased person. Compared with the current Act, the proposal increases the donors right to self- determination. Traceability and processing of personal data The Inquiry proposes that the Swedish Biobank Registry be regulated by law. The registry is to contain enough information to allow every tissue sample that belongs to or has belonged to any of the participating biobanks to be retrieved. Information such as the donors position is to be registered. All care providers – but not others – are to be obliged to provide this information to the Swedish Biobank Registry. If a donor objects to a tissue sample being stored, it will then not be registered in the Swedish Biobank Registry. It will also be possible for the registered person to specifically object to information about a tissue sample being registered in the Swedish Biobank Registry. In this case, information is only registered within the organisation where the sample was taken. The Inquiry has been tasked with proposing traceability regulations for tissue samples The Inquiry considers that adequate documentation must always exist to enable the identification of every tissue sample that belongs to, or has belonged to, the biobanks, so that donors are able to utilise their right to self- determination. Under its terms of reference, the Inquiry has also been tasked with considering the of regional biobank registries. has, however, already done considerable work on establishing the Swedish Biobank Registry. This work is now so advanced that the system will soon be launched. The Inquiry has weighed the pros and cons of registering all tissue samples in the Swedish Biobank Registry and found that the benefits prevail when samples are collected within the care system. The main benefit is that it will become easier for donors who want to change their position on whether a sample may continue to be stored if it is registered in the Swedish Biobank Registry. This is particularly relevant when a donor has given samples in a number of different circumstances, such as at a private clinic, then at a clinic at a county hospital and then within the highly specialist care system of another county council. It can also be the case that the donor has moved and thus given samples in different parts of the country. It cannot be assumed that a donor remembers the circumstances under which the samples were taken for storage at the biobank. The Inquiry proposes that biobanks – outside the care system – that collect or store tissue samples without registering them in the Swedish Biobank Registry are to be required to keep a registry (biobank register) with data that are equivalent to that stored in the Swedish Biobank Registry. When tissue samples that are not registered in the Swedish Biobank Registry are collected for a biobank that has another principal than the one collecting the samples, they are also to be registered where they are collected. The reason for registration of this kind is to ensure that the biobanks provide adequate traceability. The Inquiry proposes special provisions on the processing of personal data in the Biobanks Act. The provisions are to provide privacy protection for the individual when personal data is processed at the biobank. The provisions on personal data in the Biobanks Act are not to apply to the processing of personal data relating to care and treatment, research or other such activities that are conducted in connection with the biobank. The Inquiry proposes that a biobank may process personal data for the following reasons: -to guarantee the traceability of tissue samples in activities conducted in accordance with the Biobanks Act, -for the submission of information and the release of tissue samples that take place in accordance with acts or ordinances, and -for supervision, research and the generation of statistics. The Inquiry proposes that a biobank may only process personal data concerning: -the donors identity, -other people involved in a decision on the storage of the sample tissues, -the position taken regarding the storage of tissue samples, -the identity, character and use of tissue samples, -who processes information or tissue samples, and -to whom the tissue sample is released, transferred or provided. Information concerning analysis results, diagnoses or similar matters may not be processed. The Inquiry proposes that personal data may not be processed if the individual objects in cases where the storage of the associated tissue sample is dependent on the individual's position on storage. If, in such a case, the individual opposes the processing of personal data after it has begun, the data is to be destroyed as soon as possible. Other forms of processing personal data that are permissible under the Biobanks Act are to be permitted even if the individual is opposed to such action. The proposal introduces a right to self-determination which prevents the Swedish Biobank Registry and other biobank registries from processing personal data against the wishes of the donor except in cases when tissue samples may be stored regardless of the donors position (for example, in communicable disease control and compulsory mental care). The Inquiry proposes regulations requiring the party responsible for personal data to provide a high level of IT security. The Inquiry proposes less formal yet clearer requirements concerning the release of tissue samples from biobanks. The current Biobanks in Care Act contains restrictions on the types of samples that may be released and a ban on the release of tissue samples that have already been released. The Inquiry proposes that these regulations be revoked. Instead, the Inquiry proposes the introduction of a series of new and adjusted requirements. The Biobanks Act is to stipulate that tissue samples belonging to a biobank may not be released for purposes that are contrary to the purposes for which the biobank is registered or contrary to the purposes for which the tissue samples are stored. In addition, tissue samples are not to be released if there is reason to assume that the recipient lacks the ability to handle the tissue samples in accordance with the requirements of the Biobanks Act. Before tissue samples are released, the releasing biobank is to be required to make it conditional that the receiver may only store and use the released tissue samples for the purposes for which they have been released to them. Furthermore, prior to the release of the tissue samples, the releasing biobank is to be required to set the following conditions for a recipient that is not a biobank according to the Biobanks Act: -The recipient is to maintain adequate documentation so that every released tissue sample can be retrieved on request from the releasing biobank. -The recipient is to guarantee that the donor of the released tissue samples is, at minimum, given a corresponding right as that stated in the Biobanks Act to object to the storage of a tissue sample at any time. The reason for this amendment is that the Inquiry believes that the emphasis in the regulation should not lie on forms for making tissue samples available. Rather, the emphasis should lie on meeting the requirements to protect the individual before a tissue sample may be made available to a third party. It is also important to facilitate access to tissue samples from biobanks for use in research. The Inquiry proposes that the current obstacles to sending tissue samples to recipients in other countries be removed. They are to be replaced by a provision that tissue samples belonging to a biobank may not be made available to a third party recipient if this involves personal data being processed in breach of the regulations contained in the Act (1998:204) concerning the transfer of personal data to countries outside the EU and EEA. In addition, the Inquirys proposal concerning requirements on contractual terms regarding traceability and self-determination applies with regard to all recipients abroad. As is the case today, the Inquiry considers that permission from is to be required before a biobank or tissue samples may be transferred to another principal. Special grounds will still be required before granting permission for a transfer. The Inquiry proposes that when assessing whether or not there are special grounds for a transfer, the extent to which the donors interests can be upheld following the transfer are to be considered. Permission from is also to be required for a biobank to be made available to others, for example rented out. It is thus to be treated in the same way as a transfer. Identifying deceased persons, paternity investigation and criminal investigation The inquiry proposes that tissue samples from a biobank may be released for the identification of deceased persons, both when a need has arisen following a major disaster and for individual deaths. Release may only be allowed if the identity of the deceased has been preliminary confirmed. A tissue sample and the associated personal data may only be released following a request from or a authority, including and the Disaster Victim Identification unit. Biobanks are to be obliged to release samples and information to these authorities upon request. The Inquiry proposes that tissue samples from a biobank may be released for investigations into paternity or parenthood under Chapter 1, Section 9 of the Children and Parents Code, but only if the tissue sample to be released comes from someone who is deceased or whose whereabouts are unknown. A tissue sample and the associated personal data may only be released to , and only after a court hearing. The Inquiry proposes that the Swedish Code of Judicial Procedure stipulate that tissue samples covered by the Biobanks Act may not be confiscated for the investigation of crime. This provision means that tissue samples from biobanks covered by the Biobanks Act may not be used for the investigation of crime. BetydelseEn åtgärd som medför att ett vävnadsprov är identifierbart.En samling bevarade vävnads- prover och den organisation som hanterar dessa.Vårdgivare, forskningsinstitution eller annan som innehar en biobank.Verksamhet som omfattas av hälso- och sjukvårdslagen (1982:763) eller tandvårdslagen (1985:125).43 1 Förslag till biobankslag (2011:000) Härigenom föreskrivs följande. 1 kap. Allmänna bestämmelser 1 § I denna lag regleras hur humanbiologiskt material, med respekt för den enskilda människans integritet, ska få samlas in, bevaras och användas för vissa ändamål. 2 § I denna lag används följande beteckningar med nedan angiven betydelse. Huvudman för en biobank Identifierbart vävnadsprov Vävnadsprov vars ursprung direkt eller indirekt kan härledas till den eller de människor eller från vilka det härrör. En åtgärd vid hanteringen av uppgifter med en kod som inte är vilken ett vävnadsprov har tagits, burit ett från vilket ett vävnadsprov har tagits. och kommun i fråga om sådan kommunen har ansvar för samt annan juridisk person eller enskild näringsidkare som bedriver hälso- eller från ett , oavsett om materialet består av vävnad, celler eller beståndsdelar av vävnad eller 3 § Lagen är tillämplig på 1. biobanker i för identifierbara vävnadsprover a)i hälso- och sjukvårdsverksamhet, b)i forskning och utbildning, c)i verksamhet som avser framställning av läkemedel och medicintekniska produkter, och d)i annan därmed jämförlig verksamhet, samt 2. identifierbara vävnadsprover som samlas in från provgivare eller avlidna till sådana biobanker som avses under 1. 4 § Lagen är inte tillämplig på vävnadsprover som endast bevaras i avvaktan på analys. Lagen är dock tillämplig även på sådana vävnadsprover, om de bevaras från provtagningstillfället eller om de bevaras eller används för något annat ändamål än det för vilket de har tagits. 5 § Lagen är tillämplig på vävnadsprover som samlas in och bevaras för transfusion, transplantation, insemination, befruktning utanför kroppen eller framställning av läkemedel eller medicintekniska produkter endast om de bevaras från provtagningstillfället eller om de bevaras eller används för något annat ändamål än det för vilket de har tagits. Lagen är inte tillämplig på vävnadsprover som endast bevaras för kvalitetssäkring vid transfusion eller transplantation. 6 § Har ett vävnadsprov bearbetats så att dess ursprungliga egenskaper har förändrats i avsevärd utsträckning, är lagen inte längre tillämplig på det. Befruktning utanför kroppen av ett mänskligt ägg eller andra liknande åtgärder medför inte att lagen upphör att vara tillämplig på ägget. 1 § När verksamheten i biobanken har påbörjats ska huvudmannen för biobanken ta ställning till vilket eller vilka ändamål som biobanken ska användas för samt vem som ska vara ansvarig för biobanken. 2 § Huvudmannen för biobanken ska se till att det finns förutsättningar för att lagens krav ska kunna uppfyllas i verksamheten. Den ansvarige för biobanken ska leda verksamheten i enlighet med lagens krav och ska se till att det finns en fortlöpande kontroll av att lagen följs. Dessutom har huvudmannen för biobanken och den ansvarige för biobanken uppgifter enligt 5 kap. 7 §. 3 § Vävnadsprover får endast samlas in, bevaras och användas för vård, behandling, kvalitetssäkring, transfusion, transplantation, framställning av läkemedel och medicintekniska produkter, andra medicinska ändamål, utvecklingsarbete, utbildning, forskning eller ändamål som avser annan därmed jämförlig verksamhet. 4 § Vävnadsprover får samlas in och bevaras vid en biobank för ändamål som avser forskning endast om insamlingen och bevarandet av vävnadsprover och känsliga personuppgifter enligt 13 § personuppgiftslagen (1998:204) har prövats och godkänts av en etikprövningsnämnd. Vid prövningen och godkännandet tillämpas vad som föreskrivs om utgångspunkter för etikprövningen i 7-11 §§ lagen (2003:460) om etikprövning av forskning som avser människor. I fråga om handläggningsordningen för prövning och godkännande samt om överklagande tillämpas föreskrifterna i 24-33 §§ samt 36 och 37 §§ samma lag. 5 § De vävnadsprover som hör till en biobank ska förvaras på ett sådant sätt att de inte riskerar att förstöras och obehöriga inte får tillgång till dem.