In a strange twist of events, the proposed Clinical Drug Act will not be supervised by the Ministry of Health, but instead by the Ministry of Finance, professionals in the health sector claim.
The Act, still in draft form, will provide guidelines to allow for drugs to be tested on humans. On condition of anonymity, a source who works in the health sector explained that this law could risk lives. Human drug trials are heavily regulated in areas like Europe and Japan, making them costly, he said.

As such, in an effort to save money, several companies were interested in shifting towards the subcontinent, where there are more patients.
“We may have a high literacy rate, but there is a difference between reading and actually understanding complex information,” the source said.

As such, Sri Lankans could be signing up for clinical trials in the future, while being totally unaware of the risks involved. The patient load for instance could make it hard for local doctors to maintain the same standards when conducting drug trials as in the West.

To make matters worse, heavy emphasis is being placed on foreign investment and money. Hospitals and doctors who provide patients for clinical trials can expect to receive a lump sum between Rs. 100,000 and Rs. 150,000 per patient.

Several newly-opened companies and physicians have already set up practices and are ready for small-scale human trials, knowing that the Act will soon be in place, the source said.
At present, the pharmaceuticals industry is governed by the 1980 Act. The new Act will be separate to this, and will also allow for foreign-based companies to conduct clinical trials in Sri Lanka.
The major issues in the pharmaceutical industry centre around drug quality and affordability. However, instead of addressing these basic issues, it had been decided to focus solely on clinical trials, as they could prove a lucrative source of money, the health sector official accused.
Several ethical considerations were outlined. One was the issue that trials only last for a limited period. Patients might receive a drug that helped them immensely, only to have it discontinued at the end of the trial, leaving the less well-off to rely on more inferior drugs, to the detriment of their health. In addition, those drugs that are registered abroad would likely be more expensive, and once again the subject would have to revert to buying cheaper drugs once the trial period is over, if it was too expensive.

The question of what happens in the event of an allergic reaction to the drugs, and whether the cost would be borne by the hospital, the drug company or the patient needs to be addressed. It was also asked if medical costs would be borne by the state in the event of this happening, and whether there would be funds allocated for this purpose.

The reason all these questions are being raised is mainly because the health sector has had limited access to the draft for the proposed Act. A two page synopsis has been provided, but as the source noted, the actual wording of the laws were a mystery. A small focus group of health sector professionals had been consulted, and had raised myriad concerns in terms of ethics. It was not even known if there would be a regulatory body to oversee the trials, it was noted.

In the meantime, answers were not immediately forthcoming from the Ministry of
Health. Secretary Dr. Ravindra Ruberu, Additional Secretary Dr. Mahipala and Deputy Minister Mahinda Amaraweera were all unavailable for comment, as were members of the Government Medical Officers Association. However, Dr. Mahipala has gone on record saying that experts in the field including university professors, members of the Sri Lanka Medical Association (SLMA) and Drug Regulatory Authority had been consulted. He had added that the Bill would be presented for public consensus before being tabled in Parliament.

Professor Asitha de Silva of the Ragama Department of Pharmacology, had reportedly said that Sri Lanka was badly in need of ethical guidelines for clinical trials in Sri Lanka, and that a new Act was sorely needed.

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