Top
medical academics have warned of the danger of hasty legalization of clinical
trials on new drugs using Sri Lankans as guinea pigs and urged the government
to put on hold a Bill it was planning to present to Parliament to that effect.
Some medical experts who have read the draft
Bill said that there were provisions that would endanger the lives of patients.
Those provisions overlooked the issues such as accountability, compensation and
managing patients in the event of an adverse reaction following a clinical
trial, a senior doctor said.
The process of legalizing the clinical trials
began about two years ago, according to doctors. Now the Bill had been drafted.
The first draft had been presented to a select group of persons and
organizations.
There were major deficiencies in the make-up
of the so called 'regulatory committees' and 'expert panels', said doctors,
claiming that the government had not entertained comments from medical experts.
Instead the government had promised to obviate shortcomings and present a
revised draft for comments.
"Now the final draft has been prepared
but it has not been made available for comment; only synopsis of the Bill is
being circulated for comment among a small group of people," a medical
expert said adding that there was no point in asking comments on a synopsis.
The draft should be available in full for
observation and comment. It should be made public and its provisions should be
openly debated as it directly involved the life and death of the people of this
country, he said.
Another doctor said that there were strong
suspicions that some vested interests were trying to rush the Bill through
Parliament without giving the people an opportunity to study it. Urgent action
was needed to safeguard people against the harmful effects of clinical trials,
he said.
Additional Secretary to the Health Ministry
Dr. Palitha Maheepala, when contacted by The Island for comment, said that the
drafting of the Bill was nearing completion and it would be presented to
Parliament shortly.
Dr. Maheepala claimed that the Health Ministry
had consulted all experts in the field including university professors, Sri
Lanka Medical Association (SLMA), Drug Regulatory Authority, etc. and the final
draft was yet to be released by the Legal Draftsman's Department.
According to him, it would be presented for
public comment, Parliament's consultative committee and Cabinet of ministers
prior to being tabled in Parliament.
The Government Medical Officers Association
(GMOA) said they were not aware of any such Bill, but they had heard that the
ministry was preparing something during the last few years.
GMOA General Secretary Dr. Chandika
Epitakaduwa said that according to their information university teachers in the
medical field were mostly involved in compiling it.
"We don't know the content of the draft
Bill so far," he said, adding that therefore it was difficult to say
whether it was good or bad.
However, the GMOA would make its position
known after studying the Bill, Dr. Epitakaduwa said.
General Secretary of the All Ceylon Health
Services Union Gamini Kumarasinghe, asked why there was such a hurry to compile
an act at a time a vast amount of malpractices were taking place in the health
sector said the government had to attend to the burning problems the health
sector was facing without being preoccupied with clinical trials on new drugs.
He said he had not seen the Bill.
A senior doctor, speaking to The Island on condition
of anonymity alleged that at present some consultant doctors were paid as much
as Rs. 150,000 (US$1,317) by drug companies for using a patient for clinical
trial. He said according to media reports the Indian government had admitted
that 1,725 persons had lost their lives due to drug trials during the last four
years.
According to reports submitted to Indian
Parliament by their Health Minister, the number of deaths has risen from 132 in
2007 (288 in 2008) to 668 in 2010 (637 in 2009), indicating flaws in regulatory
controls over the US$ 400 mn sector.
Prof. Asitha de Silva of the Department of
Pharmacology of the Ragama Medical Faculty said that they provided technical
information to prepare the bill.
He said that there were no guidelines or
ethical framework to carry out clinical trial in Sri Lanka and it was a minus
point of the country's health sector.
"This act is much needed now," Prof.
de Silva said.
According to him several bills were stuck in
the ministry at the moment and they sought immediate action from the ministry
to implement drafted bills.
Prof. de Silva said that there were laws for
doing clinical trails in other countries, but it was a shame that Sri Lanka did
not have such laws.
President of the Sri Lanka Medical Association
(SLMA) Prof. Vajira Dissanayake when contacted by The Island said that they
received a synopsis of the draft bill from the ministry, but the SLMA Drugs
Committee asked for the entire bill to discuss.
"Around one year ago, the SLMA drugs
committee discussed the bill and sent out proposals," he said adding
however, the SLMA was yet to receive the new bill with the changes.
Dr. Dissanayake said however, a special
meeting scheduled to be held last week in this regard with the Minister was
postponed.
Dasun Edirisinghe
The Island
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