A new biobank law
Translated from Swedish by AI; the translation may contain errors. The Swedish text is the original.
Summary AI, written in advance
The debate concerned a new biobank law intended to replace the current law in order to strengthen Swedish healthcare and research 1 2. S moved for approval of the bill as it meets the needs of patients and research 1. SD moved for approval of the committee's proposal and emphasized that biobanks are crucial for medical progress and that the new law strengthens and clarifies the regulation 3. M moved for approval and stated that research on biological material is important, especially for incapacitated persons where the marginal benefit must be weighed against privacy 4. KD moved for approval and argued that the law strengthens healthcare and research 2. MP moved for approval 5. L thanked for the bill and emphasized the importance of including incapacitated persons in the research 6.
Written by AI in advance and may contain errors. The numbers lead to the speech a statement builds on; check against the text below.
Dzenan Cisija (S)
Madam Speaker! The previous Social Democratic government proposed that the Riksdag should decide to replace the current law on biobanks in health and medical care with a new biobank law but also fine-tune a number of related laws, such as the Ethical Review Act for research involving human subjects, the Genetic Integrity Act, the Public Access to Information and Secrecy Act, and the Patient Act.
The new biobank law is a modern law that is applied directly to identifiable samples collected for care, research, or product manufacturing, but also for education, quality assurance, and the development of healthcare operations.
The new biobank law takes precedence over other laws that may conflict with it. The law no longer recognizes the system of primary and secondary biobanks, and these are removed.
If the patient has already given their consent according to the Patient Act or the Dental Care Act, no further consent is required to collect, preserve, and use samples for the patient's care. If it concerns the use of samples for research purposes, approval will be granted by the Ethical Review Authority or the Appeals Board for Ethical Review.
We are removing the prohibition on storing samples abroad. The rules regarding making samples available outside the biobank will become clearer, and it will be possible to send samples for certain measures, for example for research, identification of the deceased, or investigation of patient injury.
Madam Speaker! I am pleased that the Committee on Health and Welfare has not tabled any motion opposing the Riksdag's adoption of the previous government's bill, not least because the proposals do indeed meet the needs of patients, research, and healthcare.
On behalf of the Social Democrats, I move for the approval of the bill.
I would then like to add that the Social Democrats support what is stated in the motion regarding research on samples from incapacitated persons. We do not consider this to contravene the spirit of the Ethical Review Act to protect the individual and respect human dignity in research.
Anna-Lena Blomkvist (SD)
Madam Speaker! Today we are debating the Social Affairs Committee's report SoU4 A new biobank law, and I would like to begin by moving for the approval of the committee's proposed decision.
Madam Speaker! Biobanks are needed because they enable the preservation of samples while, with the support of the Biobank Act, safeguarding everyone's privacy and right to self-determination. Above all, it is about the patient having the opportunity to receive the best possible care and that the valuable knowledge accompanying a biobank sample is not lost.
We have probably all in here, in one way or another, been touched by the biobank and its significance. Perhaps we ourselves or a close relative have benefited from all the research conducted with the help of the nearly 150 million samples that have been saved in Sweden.
There are several examples of important discoveries through biobank samples. For example, the HPV vaccine could be developed thanks to saved samples. The HPV virus can, in rare cases, cause cervical cancer, but today both girls and boys are offered vaccination against the virus. It is a fantastic way to save lives and a discovery that was made thanks to the biobank.
We also have the important PKU tests, which have been taken on newborns in Sweden since 1968 and still today ensure that children who are born have a lower risk of developing a number of serious diseases. These samples have been stored in a biobank since 1975, which has had a major impact on research on diseases in children in Sweden.
Research contributes to both today's and future's solutions within healthcare. I read a funny analogy somewhere – that a biobank "can be likened to a time machine where the possibility of going back in time makes it possible to find answers to medical riddles." It is a quote that evokes both one and two thoughts in me, Madam Speaker, and which at least gives me great hope for future research in Sweden as an important part of healthcare.
In order for us in Sweden to be able to have a secure, regulated and ethical biobank, we have had a Biobank Act since 2003. It is with this as a basis that the government now proposes a new Biobank Act, which the committee has unanimously chosen to support, with an addition in the form of the follow-up motion from the Liberals where we also support the proposal regarding the changed regulation concerning research on samples from incapacitated persons.
The purpose of the Biobank Act is that biobanks shall make human biological material available for research, development, care and treatment without the individual's privacy being compromised.
The most important part of the biobank laws is how the samples may be collected, stored, and used, and with today's amendment of this through the new biobank law, it will be further strengthened and clarified.
What is proposed in the new biobank law includes, among other things, a new law with an amendment to the act on ethical review of research concerning human beings and a new law on an amendment to the act on genetic integrity. All of this is done to conduct research and interpretations of the law and the biobank in an ethical, safe, and regulated manner, and so that healthcare can create a secure management of our important biobank.
As I began by saying, we have all been more or less affected by biobanks and their samples. Many in the chamber may, like me, have been born before 1975, when one began to store PKU samples in a biobank, but many of us have instead had children after 1975 and had our children's samples stored there. All of this is done in order to detect diseases in our children in time or so that researchers can help us see where potential future diseases come from and if they were already present from the beginning of life.
Madam Speaker! The Sweden Democrats view positively that we have a Biobank Act and that we are now strengthening it further through amendments in a new Biobank Act, where important changes are seen from a research perspective, with expanded areas of application, new exemptions, accessibility, application, preservation, etc.
The Sweden Democrats see this as crucial for us to receive valuable care and treatment, but also for the development and future of medical research with the help of the biobank's history. All of this happens with the biobank laws, which provide protection and ensure that we and our integrity and security are not subjected to violations.
Thomas Ragnarsson (M)
Madam Speaker! The matter of a new biobank law has been treated in the Committee on Health and Welfare, and a unanimous committee stands behind the announcement. I think it is a strength that the committee has been able to reach an agreement on a question as important as this.
By having access to biological material, research within pathology can advance, and the possibilities for new medical breakthroughs increase.
I am also pleased that we, through a motion, were alerted to the fact that according to the initial proposal, one would not be allowed to save biological material without the individual's consent. I believe that most of us in here cherish the individual's privacy. But in this case, it would mean major problems for research within certain areas, for example dementia and severe psychiatric conditions where the patient may be completely incapable of making decisions.
The committee has therefore rejected this part of the motion, and thus biological material can be collected even if consent is lacking from the individual.
Madam Speaker! This is obviously an ethical dilemma, and it is something that healthcare encounters every day. But sometimes the marginal utility of a decision must be weighed against, as in this case, the individual's personal privacy. And here we have landed on the fact that research within these disease areas would be very negatively affected if organic material were not available. That research on these medical conditions should be hindered is not reasonable, neither for those who are affected nor for those who will be affected in the future. Therefore, I move for approval of the committee's proposal.
Dan Hovskär (KD)
Madam Speaker! The proposal for a new biobank Act is now before the House for debate. The proposal means that a new biobank Act shall replace the current Act on biobanks in health care etc. from 2003.
The new law shall also regulate how identifiable human biological material, so-called samples, shall be collected, preserved, and used for certain purposes, with respect for the individual's privacy.
The new biobank law has an expanded scope of application as these provisions shall be applied directly to identifiable samples that are collected, preserved, and used for care, research, and product manufacturing, or for education, quality assurance, and development work in such activities.
Deviating provisions in other laws may not generally take precedence over the new law. And the system of primary and secondary biobanks shall be removed.
Consent to collect and retain samples for the donor's care or treatment shall not be required if the patient has consented to care or treatment according to the Patient Act or the Dental Care Act and received certain information. The Ethical Review Authority and the Appeals Board for Ethical Review shall apply for information and consent to sample handling for research.
The rules regarding the making available of samples outside the biobank are clarified, and a new possibility to send samples for certain measures is introduced.
The general prohibition on storing samples abroad was removed, and the rules for the PKU biobank are transferred to the new law largely unchanged.
The new law contains provisions on supervision, appeal, penalties and damages.
The purpose of the new law is the same as before, but some rules have been changed. It concerns regulating how identifiable, human biological material, with respect for the individual's integrity, may be collected, preserved, and used for certain purposes.
Mr. Speaker! According to the proposal, the new law shall contain provisions on how human biological material may be collected and preserved in a biobank for certain purposes and used.
The Government proposes that the new biobank law shall be applicable to identifiable samples that are collected and stored in a biobank or that are used for care, treatment, and other medical purposes in a healthcare provider's operations, for research, for product manufacturing, as well as for education, quality assurance, and development work within the framework of any of the purposes I have specified. This is a good development and something that will strengthen Swedish healthcare and research.
I move for approval of the Social Affairs Committee's proposal.
Ulrika Westerlund (MP)
Mr. Speaker! This will be a very short contribution from Miljöpartiet. I was a bit unsure whether I had to give a speech to ensure that it is clear that Miljöpartiet stands behind this. Therefore, I signed up for the speakers' list.
While I am standing here, I can take the opportunity to tell a little bit about an event one evening last week where some of our colleagues participated. We received a, for my part, advanced lecture on clinical drug trials from a company that is conducting research and which did its best to convince us that some changes are required for Sweden to be able to be considered to a greater extent for specifically clinical drug trials.
One of the things the company highlighted was exactly what Lina Nordquist has now submitted a motion on. It was then pleasing for us to be able to say that we had a debate and a decision in progress on exactly this issue. It felt a bit amusing that Lina Nordquist was a bit on her toes and that we jointly made a decision to stand behind not only the bill but also parts of Lina Nordquist's follow-up motion.
I just want to say that Miljöpartiet is pleased with this and that we also approve of the committee's proposal.
Lina Nordquist (L)
Mr. Speaker! I stand here to say thank you. The Biobank Act was needed to ensure that we can save samples for healthcare, that we can find new treatments for severe diseases, that we can ensure quality in care and perform other difficult and important tasks, for example, identifying deceased persons.
These samples play a major role. Of course, it also plays an equally large role that in all handling and use, we take care of the samples with great consideration for confidentiality and privacy, and that those who can give informed consent can say: Yes, you may take my samples, for my sake or for the sake of others.
Mr. Speaker! From the beginning, there was a gap in this bill, where the most vulnerable among us risked falling through. It was, of course, no one's intention. But the proposal meant that one could never preserve or use samples from persons who cannot give consent themselves. That may sound reasonable. But it made it extremely difficult to seek new and effective treatment for diseases that affect precisely self-determination and decision-making capacity - dementia, stroke, psychoses, and severe tumors. The disease that took these people's decision-making capacity from them would thus also prevent the possibility of finding better treatments for just this disease.
We in the Liberals therefore wrote a motion which is now the entire committee's joint proposal. It aims to try to find a cautious separate regulation when it comes to research on samples from incapacitated persons.
Each of us members realizes that this is a sensitive balance. It requires great consideration for privacy. At the same time, all of us in the committee see that patients with the diseases that affect self-determination must, of course, have good chances of receiving better treatment tomorrow.
So warm thanks, colleagues! Thank you kindly for once again showing me politics for knowledge and health when it is at its very best! Thank you so much for the craftsmanship, and thank you for the bill!
The deliberation was hereby concluded.
(Decisions were made under § 12.)
Source: The Swedish Parliament. The speeches come from the open data of the Riksdag, translated into English by AI, which may contain errors.