New Stem Cell Legislation in Europe: Are You Ready?

Stem Cell Technology Alert

by Helen G. Smith. June 2007


Three key legislative and regulatory changes affecting human stem cell regulation will occur in the UK and Europe over the next few months. Companies involved in providing materials for and researching and developing advanced therapies incorporating the latest cell and tissue technologies for use in humans, including stem cell therapies, need to be aware of these changes. Failure to comply with new regulations has serious implications and may result in criminal sanctions including significant fines. Obtaining the necessary licenses and complying with license conditions is essential.

Impact
The regulatory changes should assist in clarifying and streamlining the process for getting stem cell therapies from the R&D stage through to market. The European legislation sets minimum standards for safety, quality and related matters in the interests of safeguarding public health in the use of emerging therapies. Individual Member States are left with a wide discretion about whether to allow particular types of research and use of specific cell types. This leaves the morally vexing question of whether to permit human embryonic stem cell work to be decided on a national basis. The UK continues as one of the most permissive and supportive nations for human embryonic stem cell work and has a number of centres of excellence leading the field in this and other stem cell research. It is hoped that the upcoming changes in UK legislation will serve to further extend the UK's competitive advantage in this exciting and continually evolving field.

New Legislation
The three key changes in legislation comprise:

• UK Quality and Safety Regulations (implementing the EU Tissues and Cells Directive): comes into force July 2007;
• UK Draft Human Tissue and Embryos Bill: undergoing consultation, implementation expected 2007/2008; and
• Europe-wide Advanced Therapy Medicinal Products Regulations: due to come into force by the end of 2007.

UK Quality and Safety Regulations
The current regulatory framework for regulation of human stem cell research is split into two, governing, firstly, storage and use of human embryos¹ and, secondly, storage and use of human tissues and somatic cells.²

On 5 July 2007, new regulations further implementing the EU Tissues and Cells Directive³ come into force in the UK. The Human Tissue (Quality and Safety) Regulations 2007 and the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007 amend the current regulatory regime governing the licensing of facilities in carrying out work in relation to human tissues and cells intended to be used in human applications.

The Directive sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. The Directive's stated purpose includes establishing a unified EU framework to ensure high standards of quality and safety in the transplantation of human cells and to facilitate safer international exchange of such cells. The Regulations also implement the Technical Annexes to the Directive, which specify technical requirements for the donation, procurement and testing of human tissues and cells;⁴ and traceability requirements, notifications of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells.⁵ Due to the distinction between embryonic and other tissue types under current UK law, the Regulations have been split to reflect that. However, the two sets of Regulations are in similar terms and come into force at the same time.

The Regulations set out requirements for obtaining a license from the relevant authority (either the Human Fertilisation and Embryology Authority (HFEA) or the Human Tissue Authority (HTA) in order to carry out the various acts covered by the Directive in relation to human derived tissues and cells which are intended for use in human applications. Failure to obtain a license from the competent authority for work in this area may result in criminal conviction, with the imposition of an unlimited fine and/or up to two years imprisonment. The HFEA and HTA are also issuing revised Codes of Practice on 7 July 2007.⁶

The Draft UK Human Tissue and Embryos Bill
Further regulation in this area is on the way in the UK and across Europe. In the UK, the draft Human Tissue and Embryos Bill is currently being scrutinised by a joint House of Lords and Commons Committee, which is due to report its findings by 25 July 2007. If the bill goes through, it will create a single regulatory body, the Regulatory Authority for Tissues and Embryos (RATE) to replace the currently separate functions of the HFEA and HTA and to take over regulation currently conducted by the Medicines and Healthcare products Regulatory Agency (MHRA) in relation to blood and blood derivative work under the EU Blood Directive.⁷ The HTA, HFEA and MHRA last month issued a joint position statement on regulating stem cell research. The statement sets out the intention of the regulators to work together, in the context of the draft Bill, to streamline the regulatory process in relation to stem cell research for human application. To that end a meeting between the three regulatory bodies and the UK stem cell bank community will take place in June 2007 with the aim of clarifying the regulatory arrangements. It is anticipated that, in accordance with the draft Bill, all such regulatory functions will be undertaken by RATE. It is expected that RATE will be established in 2009 following passing of the draft Human Tissue and Embryos Bill, which is currently scheduled to take place in 2007/8.

The EC Advanced Therapy Medicinal Products Regulations
In Europe, the Council of Ministers approved the EC Regulation on Advanced Therapy Medicinal Products on 31 May 2007. All Member States supported the Regulation, which is expected to come into force across the European Union by the end of 2007. The Commission is already beginning implementation work with the European Medicines Agency. The Regulation will govern production, distribution, and use of advanced therapies, including stem cell therapies, for treating or preventing diseases in humans. It should address the current problems created by the lack of specific regulations governing emerging tissue engineering therapies and cell therapy medicinal products. The Regulation also brings all innovative therapies into a single legislative framework and sets up a centralised marketing authorisation procedure for such treatments.

Conclusion
There are dissenters to the forthcoming changes, perhaps most significantly the British Medical Association, which is urging against introduction of the single regulatory authority RATE in the UK. However, the overall effect of the changes to UK and EU Regulatory frameworks and the introduction of a single authority in the UK should considerably streamline and update the current process for licensing research and development in the advanced therapies arena. The new legislation should also mean that the regulations, to the extent that the rapid evolution of science in this area allows, remain applicable to the many new and rapidly emerging therapies likely to be created over the coming years.

Notes:
1. Derivation of human embryo stem cells is governed by the Human Fertilisation and Embryology Authority under the Human Fertilisation and Embryology Act 1990.
2. Somatic human tissue and cell use, and use of embryonic stem cell lines following derivation, is governed by the Human Tissue Authority under the Human Tissues Act 2004.
3. European Parliament Directive (2004/23/EC). These regulations also implement two technical annexes to the Directive.
4. Commission Directive 2006/17/EC.
5. Commission Directive 2006/86/EC.
6. The Codes of Practice will be published on each of the HFEA and HTA websites.
7. 2002/98/EC.

Contacts:
Sanford B. Ferguson, +1.412.355.6494, sandy.ferguson@klgates.com
Helen G. Smith, +44.(0)20.7360.8148, helen.smith@klgates.com

This publication/newsletter is for informational purposes and does not contain or convey legal advice. The information herein should not be used or relied upon in regard to any particular facts or circumstances without first consulting a lawyer