Former MLA Ellio Solomon has drafted a bill that would pave the way to allow medical research companies to conduct clinical drug trials in the Cayman Islands, with the goal of marketing and selling the resulting medications in the US and the UK.

The Medical Research Regulation Bill, once enacted into law, is intended to facilitate the establishment and supervision of research institutions, which will conduct human medical research. The law would also establish the Medical Research Authority (MRA) to license and oversee the research companies.

Solomon collaborated on the bill with Bilika Samamba, who spent 12 years as a legal drafter with the Cayman Islands Government and was recently called to the Bar.

“I believe that the Cayman Islands can be on the cutting edge of research and development, not only in the medical industry but also in such diverse disciplines as energy and information technology,” Solomon said.

He recalled discussions with Dr. Steve Tomlinson, founder of the Chrissie Tomlinson Memorial Hospital, about Cayman’s potential for medical research. As chairman of the Health Practice Commission, Dr. Tomlinson met with companies who came to Cayman to inquire about the possibility of setting up research operations.

“Dr Tomlinson’s experience with those companies and his belief that there was a real opportunity for medical research here inspired me to look seriously into how we could become leaders in this field. This bill would allow that to happen,” Solomon said.

One of the most important functions of the authority as set out in the bill is to ensure the licensed research establishments in Cayman comply with the requirements of the US Food and Drug Administration and the UK Health Care Products Regulatory Agency.  This would in turn ensure that the processes relating to the clinical trials conducted in Cayman would be recognised in those two countries, opening those markets to medications that undergo testing here.

Cayman would be well placed to offer competitive advantages to holding clinical trials, Solomon explained, adding he visited FDA headquarters in December to learn more about their operations and requirements, as well as begin a dialogue on how the two agencies would be able to work closely together. “I wanted to make sure we would be able to check all of their regulatory boxes.”

He came away convinced that Cayman could offer more affordable clinical trials, as well as a more efficient approval process. “The sheer size and bureaucracy of the FDA translates into a much longer timeframe for it to process and approve clinical trials, meaning it typically takes years from the decision to start the testing to giving the go-ahead for production and marketing.”

The size and composition of the MRA would make it a more streamlined regulatory agency than the FDA, Solomon said.

The addition of medical research facilities would also broadly benefit the Cayman Islands economically, boosting government revenue, increasing expenditure in the local market and creating related jobs. Among the associated infrastructure and services that would generate revenue would be the anticipated construction of necessary buildings; the duty collected on the purchase of medical and related equipment; fees for work permits, trade and business licences, and registrations; and opportunities for local insurance companies to provide the required coverage.

In addition, each stage in the research process will require regulatory approval and therefore generate associated fees.

“The medical research industry in the US alone is valued at more than $36 billion,” Solomon added. “Once this law is passed and the MRA is set up, the Cayman Islands will be poised to get a piece of that market; a mere 1% share could potentially put approximately $360 million into the Government coffers, providing well-needed revenues to provide services and opportunities for our people and diversifying our economy.”

Solomon has long been an advocate for enhancing the medical sector in Cayman; the Medical Research Regulation Bill represents a natural progression for him.

Over the years, he has focused on issues that would improve the provision of health care. One notable example: During his time as an MLA, as chair of the relevant committee, he spearheaded the creation of the Human Tissue Transplant Law, 2013 to enable human organ and tissue transplantation.

He also negotiated the agreement that any hospital in Cayman with 25 beds or less would be able to participate in medical tourism, opening the market for greater local participation in the health sector.

For more information on the Medical Research Regulation Bill, contact Ellio Solomon at [email protected] or 923-6844.

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IMAGE: Ellio Solomon