{"id":30001,"date":"2014-05-25T23:11:49","date_gmt":"2014-05-26T03:11:49","guid":{"rendered":"http:\/\/dbsjeyaraj.com\/dbsj\/?p=30001"},"modified":"2014-05-25T23:11:49","modified_gmt":"2014-05-26T03:11:49","slug":"rational-principles-enunciated-by-prof-senaka-bibile-on-distribution-of-medical-drugs-are-being-violated","status":"publish","type":"post","link":"https:\/\/dbsjeyaraj.com\/dbsj\/?p=30001","title":{"rendered":"Rational Principles Enunciated by Prof.Senaka Bibile on Distribution of Medical Drugs are Being Violated"},"content":{"rendered":"

BY <\/p>\n

FAIZER SHAHEID<\/strong><\/p>\n

Members of the medical fraternity are seemingly disconcerted by the silence of the authorities in relation to the National Medicinal Drugs, Devices and Cosmetics Regulatory Authority Bill (NMDDCRA) currently being studied by a consultative committee.<\/p>\n

Approximately 15,000 or more registered medicinal drugs are being distributed in Sri Lanka, of which a majority is imported into the country, according to statistics from the Drug Regulatory Authority of Sri Lanka. Over time there has also been a massive influx in new drugs, a majority of which had been deemed unnecessary and expensive.<\/p>\n

<\/p>\n

Having foreseen the impending crisis, the Chandrika Bandaranaike Government in 1996 established a new health policy with the aim of executing a national drug policy for the rational use and distribution of drugs. However, despite the implementation of the policy, the complete effect was not realized.<\/p>\n

Subsequently in 2005, the United Peoples Freedom Alliance (UPFA) Government under the leadership of President Mahinda Rajapaksa established a National Medicinal Drugs Policy (NMDP) for the accomplishment of the same purpose. Following discussions with the World Health Organization (WHO) and the formulation of a constructive mechanism, Cabinet approval was obtained for the implementation of the Policy. A national standing committee was appointed to study the implementation of the principles of rational drug use recommended by Prof. Senaka Bibile.<\/p>\n

The principles of Prof. Senaka Bibile, also referred to as the Bibile Principles, had been incorporated by the Sirimavo Bandaranaike Government of the time. His recommendations had been recognized by the State when he was appointed the first Chairman of the State Pharmaceuticals Corporation in 1971. The significant impact of his proposals had led the WHO to recommend the use of his model in other developing countries as well.<\/p>\n

However, his policies were subsequently scrapped due to pressure from foreign governments, especially that of the United States of America (USA) on which the government of Sri Lanka was heavily dependent. A dejected Prof. Bibile then proceeded to assume a role with the United Nations (UN) in Guyana, where he died rather mysteriously at the age of 57.<\/p>\n

His contribution to the drug industry was highly commended during the 35th World Health Assembly in Geneva in 1982.<\/p>\n


\nThe Bibile Principles<\/strong><\/p>\n

President of the Sri Lanka Medical Council (SLMC), Prof. Carlo Fonseka had been very vocal against the proposed bill labeling it at as a travesty against the Bibile Principles.
\n“The NMDDCRA was to be established in accordance with the Bibile Principles, but we don’t see any relevance,” he said, explaining that prior to understanding the contradictory nature of the NMDDCRA Bill, the principles laid down by Prof. Bibile needs to be understood.<\/p>\n

The first principle, he explained, was the concept of essential drugs. Prof. Bibile had noted that a maximum of 1,000 drugs was sufficient for a developing country like Sri Lanka. At present, with over 15,000 drugs circulating in the Sri Lankan market and a large number of them being overpriced and unnecessary, it was important that people are eased of the burden of paying in excess merely for the brand name, Prof. Fonseka said.<\/p>\n

The second principle dealt with the prescription giving generic names. Prof. Fonseka explained that by generic names, the medicinal drugs were to be regarded by their chemical compound rather than their brands. “Many doctors prescribe drugs by brand name. This could be counterproductive and very costly. Prof. Bibile didn’t want that. He wanted the drugs to be essential, effective, safe and to be sold at affordable prices,” he said.<\/p>\n

The third principle was for the monopolization of drug imports and distribution to be minimized through the use of worldwide tenders. Prof. Bibile had also recommended the manufacturing of drugs as opposed to importation.<\/p>\n

The principles also sought to control the drug mafia, where overpriced drugs dominates other equally capable drugs. Prof. Carlo Fonseka explained that many drug companies were in the habit of promoting their drugs to an extent where other drugs with a similar chemical composition would not be able to compete.<\/p>\n

“By enabling a local manufacture of drugs, we could avoid this disparity and the unnecessary excess money paid to drug companies,” he said. Adding that there was an inundation of overpriced branded drugs in the market, and doctors and drug companies are scoring the most at the cost of the patients.<\/p>\n

Lastly, the Bibile Principles had recommended that the patent laws be reviewed. Most drug companies in the market had the tendency to patent their drugs in the market to avoid competition. As such, when a drug company had decided to introduce a new drug to the Sri Lankan market, competition would be avoided for a period of an estimated 10 years on average at a massive cost.<\/p>\n

However, such a move would ensure that other drugs would not give rise to competition and hence permit the monopoly of the drug. Such moves eventually led to the multiplication of the ordinary price.<\/p>\n

The perspectives<\/strong><\/p>\n

Prof. Carlo Fonseka went on to criticize the NMDDCRA bill stating that it was not in conformity with the Bibile Principles. There was neither a concept nor a quality control mechanism nor a regulatory mechanism stated in the 84 page draft bill, he claimed.<\/p>\n

However, Spokesman for the Ministryof Health, Dharma Wanninayake, was quick to refute the disparaging remarks. He said, “Nobody outside of the ministry has seen this 84 page draft bill. I wonder how they could make any remarks as such without having seen the content of the draft bill.”<\/p>\n

He reiterated that a standing committee had been appointed by the State to study the directives of Prof. Bibile and formulate a policy accordingly. The draft bill had subsequently been presented to the Attorney General’s Department for approval and thence proceeded to President Mahinda Rajapaksa, who had appointed a consultative committee for further study. He claimed that the passing of the bill was highly anticipated and will be welcomed by the general public.<\/p>\n

Despite the Wanninayake assurances, Prof. Fonseka expressed his scepticism towards the bill. “This is supposed to be an independent regulatory authority, but there is to be a chairman appointed by the Minister himself and there is no regulatory mechanism for the authority to make decisions.<\/p>\n

“This is not in accordance with the Bibile Principles,” he said and claimed that the Bill had been short of specifying a structure for the soon to be established authority. When asked if he had studied the draft bill, Prof. Carlo Fonseka said he had not personally studied the bill but he had been reliably informed of the flaws in the bill.<\/p>\n

He went on to question as to why the bill was not circulated among any individual or professional bodies and asked why the emergence of a bill concerning drastic changes in the medical drug industry was being kept a secret.<\/p>\n

Wanninayake dismissed the comments and stated that the bill was fully in conformity with the Bibile Principles. “The committee has been studying these Principles for a long time, and the instruction was clear that the bill should be in conformity with the Bibile principles. I can be certain that there has been no deviation from that goal,” he said.<\/p>\n

Prof. Fonseka stated that if the bill was enacted into law in a faulty manner, it may derogate all medical procedure and decapitate the Sri Lankan health system as a whole.<\/p>\n

The Peoples Movement for the Rights of Patients (PMRP) and other respected personalities in the medical fraternity also expressed similar fears in relation to the bill. Health Minister, Maithripala Sirisena, could not be contacted for comment in this regard.<\/p>\n

COURTESY:CEYLON TODAY<\/em><\/p>\n

Tweet<\/a><\/div>","protected":false},"excerpt":{"rendered":"

BY FAIZER SHAHEID Members of the medical fraternity are seemingly disconcerted by the silence of the authorities in relation to the National Medicinal Drugs, Devices and Cosmetics Regulatory Authority Bill (NMDDCRA) currently being studied by a consultative committee. Approximately 15,000 or more registered medicinal drugs are being distributed in Sri Lanka, of which a majority …<\/p>\n

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