Wellcome's response to the Human Fertilisation and Embryology Authority (HFEA): Modernising the regulation of fertility treatment and research involving human embryos

The UK is a leader in stem-cell and developmental biology research. Research in these areas is helping scientists better understand early human development and can potentially inform treatments for infertility and many congenital anomalies.

The robust and responsive regulatory framework in this area has been a key factor for such research to flourish while maintaining public confidence. Nevertheless, the principal legislative instrument, the Human Fertilisation and Embryology Act (HFE Act), was adopted in 1990 and has only been reviewed once since, in 2008.

Drawing on empirical evidence presented by clinics and researchers operating under current rules, the UK Government should review the current regime covering patient donations of gametes and embryos for research purposes, to ensure it remains fit-for-purpose.

Moreover, the absence of recent legislative revisions mean new science and technologies may find themselves either outside or in contravention of existing legal provisions. We urge the UK Government to consider the risks and opportunities associated with emerging approaches and techniques in this area, and if appropriate, develop and evaluate possible legislative amendments to manage these as soon as possible.

The first few weeks after an egg is fertilised are hugely important for human development, as organs are shaped in this period. Nevertheless, little is known about how human embryos develop in the very earliest stages. Research in this area allows scientists to better understand human development, including the causes of infertility, miscarriages and developmental conditions affecting 3% of all babies.

Studies using human embryos are technically complex, require researchers to operate within a regulated environment and adequately address ethical considerations. Research projects requiring HFEA licenses continue to represent a small part of Wellcome’s portfolio.

Wellcome’s major investment in this area is the Human Developmental Biology Initiative (HDBI), a 5-year, £10 million research project involving 25 groups from across the UK and mainland Europe. The study of biological, developmental and physiological aspects associated with pre-implantation embryos is one element of this broader initiative.

One major challenge continues to be the lack of access by research laboratories to pre-implantation human embryos. Fertility patients who want to donate their embryos to research face many challenges, for example, if their clinics do not have links with research projects or these projects are not active at the time the donation is due to take place. Additionally, many donated specimens are never used due to the nature of narrow consent procedures and requirements to re-consent for use in specific studies.     

Wellcome supports the HFEA recommendation that the current rules governing patient consent should be reviewed. While a strong ethical and regulatory framework is needed to protect embryo and gamete donors, it is important that regulators draw on empirical evidence being presented by clinics and researchers on the practical challenges of operating under the current rules and look at ways to make these more flexible where appropriate. This is needed to ensure that the will of donors is carried out, preventing human embryos and gametes from going to waste, and to allow for research in this area to continue to develop.  

We encourage the HFEA to explore all options available to facilitate a better functioning regime for embryo and gamete donation for research purposes. Further and careful consideration should be given to the suitability and feasibility of a centralised repository for research purposes and what it would entail in practice in terms of funding, value for money and appropriate governance rules for procuring and managing embryos and gametes. 

The robust and responsive regulatory framework in this area has been a key factor for such research to flourish while maintaining public confidence. While the UK was a pioneer in this area with the introduction of the Human Fertilisation and Embryology Act in 1990, the regulatory framework has only been reviewed once since, in 2008. Nevertheless, science and technologies in this area continue to develop and may find themselves outside or in contravention of existing legal provisions.

Given rapid scientific developments in this area, Wellcome supports the HFEA‘s recommendation that a more agile regulatory framework is needed. For example, the Government took an anticipatory approach to mitochondrial donation by placing a provision in the HFE Act that allowed research in this area to continue while adding flexibility for the HFEA to consider the need for clinical use in the future. Similar approaches could help ensure that legislation can be kept up to date. The Government must engage all stakeholders in a debate involving novel scientific and technical developments, and if appropriate, put forward proposals for amending the legislation.

Wellcome recommends that regulators follow a model of dynamic oversight towards novel scientific and technological approaches based on the principles of inclusivity, anticipation, innovation and proportionality. In line with the Government’s ambition to make the UK a science superpower, dynamic oversight is needed to foster a strong environment for science and attract more investment, while ensuring emerging technologies reach their full potential, with the public’s trust, both quickly and safely.

In this context, examples of issues that are due consideration include:

The adequacy of current rules limiting the growing of embryos in vitro (e.g. 14-day rule)
The 14-day rule states that no human embryo should be grown in vitro for longer than 14 days after fertilisation or the emergence of the primitive streak, whichever is first. When the 14-day rule was set, it was largely theoretical, as human embryos could not be grown in culture for more than a few days. More recently, there have been calls for the limit to be extended so that scientists can investigate early human development, the causes of early miscarriages and developmental disorders. Given recent improvements in technical capabilities, it would now be an appropriate time for the UK Government to begin dialogue activities to explore the public’s views on the 14-day rule.

How new ‘categories’ of cells should be governed 
As highlighted in this consultation, the HFE Act does not regulate ‘new ‘categories’ of cells such as in-vitro-derived gametes, embryo-like entities, and stem-cell based embryo models, nor it may be the right framework for doing so. Nevertheless, it is important that regulators provide clarity for researchers working in the field.

Interventions in the nuclear DNA of gametes or embryos 
While we recognise the future potential for germline genome editing to prevent inheritance of certain genetic conditions, the therapeutic use of such techniques continues to present significant safety and ethical concerns and should not be permitted at this time. Therefore, we currently support the development and use of these techniques for research purposes only.