Industry perceptions of barriers to commercialization of regenerative medicine products in the UK.

AIMS: Regenerative medicine is an emerging field with the potential to provide widespread improvement in healthcare and patient wellbeing via the delivery of therapies that can restore, regenerate or repair damaged tissue. As an industry, it could significantly contribute to economic growth if products are successfully commercialized. However, to date, relatively few products have reached the market owing to a variety of barriers, including a lack of funding and regulatory hurdles. The present study analyzes industry perceptions of the barriers to commercialization that currently impede the success of the regenerative medicine industry in the UK. MATERIALS & METHODS: The analysis is based on 20 interviews with leading industrialists in the field. RESULTS: The study revealed that scientific research in regenerative medicine is thriving in the UK. Unfortunately, lack of access to capital, regulatory hurdles, lack of clinical evidence leading to problems with reimbursement, as well as the culture of the NHS do not provide a good environment for the commercialization of regenerative medicine products. CONCLUSION: Policy interventions, including increased translational government funding, a change in NHS and NICE organization and policies, and regulatory clarity, would likely improve the general outcomes for the regenerative medicine industry in the UK.

What can be learnt from the Japanese regulatory approach to tissue engineered products?

The Japanese government has recognized the challenges its rapidly aging population presents, especially in terms of healthcare provision, and is focusing on the potential of regenerative medicine to address them. The country has consequently embarked upon a national program to support development of this field. In 1999 Japan initiated a national research project in science and technology, known as the Millennium Project, whose areas of research include tissue engineering covering skin, cornea, bone, cartilage, blood vessels, nerves and bone marrow. In this context, at a time when regulations for tissue engineered products are being developed and revised in the USA and at the European level, it is interesting to investigate what type of framework Japanese regulators have designed to deal with these products in order to see what lessons might be learnt by UK, US and EU regulators. This paper reviews negative and positive aspects of the current regulatory situation that applies to tissue engineered products in Japan but will mostly focus on examples of good practice, such as the pragmatism that underpins the Japanese regulatory strategy, the international involvement of the country when it comes to developing regulatory standards and the promotion of a supportive public environment.

Will regulation determine the science agenda? A look at hESCs.

Given the significant controversy over human embryonic stem cell (hESC) isolation and research, regulation of such work around the world has proceeded in an uncoordinated manner. In general, advances in science cause a need or desire for regulation; however, it has been the opposite for hESC research--regulation and policy have set certain boundaries for scientific research and defined other research questions. This is especially evident in the USA, where federal funding policies have engendered specific research towards novel methods for isolating such cells that do not require destruction of human embryos. Due to the multiplicity of national policies, it will be almost impossible to reach global consensus in the near future. Nonetheless, this paradigm of regulation leading science may have significant implications for future research projects. Changes in hESC policy in the short term will influence longer-term research potential.

Regulation of tissue-engineered products in the European Union: where are we heading?

The emergence of tissue-engineered products (TEPs) raises a standard question for regulators: is the existing regulatory regime appropriate or is there a case for a new regulatory framework? In the USA, the FDA has developed a risk-based approach to TEPs, whereas in Europe, a common regulatory strategy for these products has not yet been implemented. In order to fill this perceived gap, member states have set up domestic rules, which has led to an unclear and patchy regulatory situation. The Regulation on Advanced Therapy Medicinal Products, voted on by the European Commission in November 2005, has been developed by European Union regulators to provide the necessary framework to regulate TEPs. As the text is still to be discussed and to be passed, many concerns have been raised regarding the appropriateness of the proposed framework.