Scientific progress requires that legislators and regulators around the world recognize and appreciate the value of research and actively support pro-science policies. The ISSCR, through its policy program, champions the advancement of stem cell research and its translation to medicine. On behalf of our members, we:
- develop research guidelines and advocate for their adoption by governments around the world as they promulgate new regulations;
- advocate broadly for increased research funding;
- liaise with policy makers to ensure sound scientific reasoning underlies decisions regarding stem cell research and its translation to the clinic;
- educate patients and the public about stem cells through the A Closer Look at Stem Cells website.
Our advocacy efforts focus on support for basic science research, evidence-based regulation of science as it is translated to the clinic, responsible research freedoms, and increased funding for science.
Our broad support for science funding includes discussion about the tremendous potential that stem cell research has in addressing diseases and disorders for which there are currently no cures. We highlight with legislators and regulators the very real advances taking place every day in labs around the world, and the benefits of investing in science that can transform human health.
While budgetary considerations are always a priority, we also advocate for science to be respected and considered by those in elected and appointed office. It is vitally important for us to communicate effectively with legislators, sharing findings that show the value of research, and advocating for funding necessary to further it. The key role that science should play in informing policy decisions cannot be overstated.
Promulgation of Research & Clinical Standards
The ISSCR’s Guidelines for Stem Cell Research and Clinical Translation remain the standard for scientific integrity and the ethical clinical translation of stem cell research for researchers, regulators, ethics committees, and institutional review boards around the world. They are particularly important as the pace of research accelerates toward the clinic. We were pleased that Nature journals announced a policy encouraging scientists using human embryos and embryonic stem cells to embrace the ISSCR guidelines as they design, execute, and report their research.
Earlier this year, we released Stem Cell-Based Clinical Trials: Practical Advice for Physicians and Ethics/Institutional Review Boards. Developed by the Clinical Translation Committee, this guidebook is designed to help physicians and review boards assess prospective stem cell-based clinical trials. As the science continues to emerge, we endeavor to meet the need for new or updated guidelines.
Advocacy in Europe
In an April comment letter to the European Commission (pictured), we encourage the European Union (EU) to continue its investment in science research, particularly in innovative basic science that can often have far-reaching impacts in unexpected areas. The discoveries of CRISPR and somatic cell reprogramming, for example, show that research in one area may broadly impact understanding in another, with results that fundamentally change the future of medicine. The current 7-year research funding program in the EU is winding down (2014-2020), and our comments are timed to have an impact as the Commission considers budget priorities for the next 7 years in the 9th European Framework Programme for Research and Innovation.
ISSCR members Michele De Luca and Peter Coffey, along with Policy Director Eric Anthony, met with the European Parliament’s Committee on Industry, Research, and Energy to advocate for basic research funding, underscoring the importance of funding the most promising and rigorous research. (De Luca and Coffey pictured here with Vanessa Aulehla and Cecile Heriard of the Committee).
Recent Policy Successes in the US
We joined with several other scientific organizations in successfully advocating for additional research funding in the 2018 US budget. In a letter to House and Senate leadership signed by 217 patient, academic, scientific, and other groups, we advocated to expand the budget for the National Institutes of Health (NIH), and were pleased when Congress passed legislation providing a $3 billion increase. In addition, the ISSCR lead a coalition of science groups in support of fetal tissue research, derailing a proposed funding ban.
International Regulatory Efforts
Regulatory changes in the EU (2015) and the US (2017) addressed areas that have long been concerning to the ISSCR, particularly with the proliferation of clinics marketing and selling unproven stem cell therapies. In clarifying the definition of ‘homologous use’ and ‘minimal manipulation,’ regulators have provided guidance about what products fall under regulatory review. We support these new efforts and hope to work globally with governments to strengthen the regulation of stem cell products and therapies, following the lead of the EU and the US.
Recently we have engaged with Australia and India as they look to rework their cell therapy regulations. In letters to Australia’s Therapeutic Goods Administration (TGA) and to India’s Secretary of the Department of Biotechnology we support fortifying regulations regarding stem cell-related products. In alignment with our advocacy efforts, the TGA has proposed a new framework for stricter regulations concerning autologous human cell and tissue products meant to halt the marketing and administration of unproven therapies. We continue to encourage countries around the world to adopt strong rules to protect patients from predatory stem cell clinics.
If you know of advocacy needs or opportunities in your region of the world, please contact Eric Anthony with those ideas.
Reliable Information About Stem Cells and Their Potential Impact
It has never more important to provide the public with reliable, accurate information about stem cell science and its translation to medicine. We actively maintain and promote the society’s A Closer Look at Stem Cells website to inform the public and patients about stem cells and their potential for use in the clinic.
As a member, you play a critical role in all our efforts. Your voice allows us to be heard in policy and regulatory debates around the world and helps us communicate with the public. This is my final column as president of the ISSCR, and I want to thank you for your support throughout this year. It has truly been an honor to serve.