This page lists the laws and official bodies in the Atlas that relate to prion disease. Each entry has its own page with the source text. The entries describe what a rule says. They do not tell you how a rule applies to your situation. A lawyer or the relevant authority can do that.
Which rules are in the Atlas?
How are blood and tissue regulated in the UK?
Blood services work under the Blood Safety and Quality Regulations 2005, and the Medicines and Healthcare products Regulatory Agency is the competent authority. Tissue services work under the Human Tissue (Quality and Safety for Human Application) Regulations 2007, and the Human Tissue Authority is the competent authority. The Advisory Committee on the Safety of Blood, Tissues and Organs advises ministers and does not regulate services.
How are medicines advised on in the UK?
The Commission on Human Medicines was established in October 2005. It advises ministers and the licensing authority on the safety, efficacy and quality of medicines, and it promotes the collection of information about adverse reactions.
What is the EU baseline for tissues and cells?
Directive 2004/23/EC is the main EU law on tissues and cells, from donation to distribution. Several further directives set technical requirements for donation, testing, traceability, processing and imports. These rules are a common baseline, and Member States may apply stricter rules.
What does Canadian law say about genetic testing?
The Genetic Non-Discrimination Act bars requiring a genetic test as a condition of receiving goods or services or of entering a contract. It also bars refusing those things because a person declined a test. It sets rules on sharing results as well, and requires written consent before test results are collected, used or disclosed in those dealings. Whether to have a genetic test is a personal choice, and genetic counselling comes first.
Where can I read more?
The studies behind these rules are on Key papers. Sources are listed on Sources. The Atlas home has the other sections.
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- Genetic Non-Discrimination Act of Canada (2017)The Genetic Non-Discrimination Act (S.C. 2017, c.
- Arbeitskreis Blut statement S 27 on variant CJD: exclusion criteria for blood and plasma donation (Germany, 6 December 2024)S 27 is a statement of the Arbeitskreis Blut, the national expert advisory committee on blood that sits at the Robert Koch Institute, on donor exclusi
- Real Decreto 21/2013, Spanish national programme of genetic selection for TSE resistance in sheepReal Decreto 21/2013 of 18 January 2013 is the Spanish royal decree that runs the national programme for breeding sheep that resist transmissible spon
- Real Decreto 3454/2000, Spanish integrated programme for surveillance and control of animal TSEsReal Decreto 3454/2000 of 22 December 2000 is the Spanish royal decree that set up the coordinated national programme for surveillance and control of
- Regulation (EC) No 999/2001, EU rules for the prevention, control and eradication of TSEsRegulation (EC) No 999/2001 is the EU framework law for transmissible spongiform encephalopathies (TSEs) in animals.
- CHMP reflection paper on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products, revision 3 (EMA, 2024)This is the European Medicines Agency text that sets the EU scientific position on prion risk for medicines made from human plasma (such as immunoglob
- Commission Directive 2004/33/EC on technical requirements for blood and blood components (EU donor eligibility, including permanent TSE deferral criteria)Commission Directive 2004/33/EC of 22 March 2004 is the EU implementing act that sets who may give blood and blood components.
- Commission Directive 2006/17/EC on technical requirements for donation, procurement and testing of human tissues and cells (donor exclusion criteria including prion disease)Commission Directive 2006/17/EC of 8 February 2006 is the EU implementing act that sets who may donate human tissues and cells and which tests donors must have.
- EMA guideline on the investigation of manufacturing processes for plasma-derived medicinal products with regard to vCJD risk (EMEA/CPMP/BWP/5136/03, October 2004)This is the European Medicines Agency method guideline that tells makers of medicines from human plasma (such as clotting factors, immunoglobulins and
- Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin (SoHO Regulation)Regulation (EU) 2024/1938, the SoHO Regulation, is the single EU law that will govern the quality and safety of blood, tissues, cells, reproductive ce
- Protocole standard prion (PSP), French standard protocol for judging prion inactivation products for reusable medical devices (ANSM, v2011 and v2018)The protocole standard prion (PSP) is the French laboratory method that a manufacturer must follow to show that a cleaning, disinfection or sterilisat
- HFEA, Human Fertilisation and Embryology Authority (UK fertility regulator), PGT-M condition approvalsThe HFEA is the UK's independent statutory regulator of fertility treatment and research using human embryos, an arm's length body of the Department o
- Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), United KingdomSaBTO is the UK expert advisory committee that advises ministers and health departments on how to keep blood, cells, tissues and organs used for trans
- UK Code on Genetic Testing and InsuranceThe Code is a voluntary, open-ended agreement between the UK government and the Association of British Insurers (ABI), published in October 2018, whic
- Genetic Information Nondiscrimination Act of 2008 (US)GINA is a US federal statute, approved on 21 May 2008, with two working parts: Title I on health coverage and Title II on employment.