About 40 years after the then Sirimavo Bandaranaike Government was virtually forced by the United States to scrap the Essential Medicines Concept of the revered Professor Senaka Bibile and nine years after the Cabinet approved a National Medicinal Drugs Policy (NMDP) based on this concept, the Health Minister on March 11 presented a new Bill with a lot of publicity.
The 84-page Bill for the setting up of a National Medicinal Drugs, Devices and Cosmetics Regulatory Authority (NMDDCRA) to monitor the import and sale of medicinal drugs and devices is now before the Cabinet. But pharmacology professionals and health rights groups have written to Health Minister Maithripala Sirisena warning that if this Bill is enacted in the present form, the whole nation will suffer for generations and the free health service may collapse.
In the letter the professionals say it appears that only a few individuals have drafted this Bill and it has been kept as a secret from most of the citizens of Sri Lanka. The Bill deals with life or death for millions of people and therefore the people and health rights professionals should be given a full opportunity to diagnose it and propose changes.
The purpose of this Bill was to implement the 2005 NMDP which was approved by the Cabinet and was based on Prof. Bibile’s Essential Medicines Concept. However, the proposed Bill clearly violates the principles of the 2005 NMDP.
The main intention of establishing the NMDDCRA is to rectify the major issues in drug regulation in the country. It is widely known that the present system is not effective and leads to corrupt practices, thousands of substandard drugs being imported, frequent quality issues, frequent shortages and a huge financial burden for the Ministry of Health. The NMDP had proposed the setting up of a National Medicinal Drugs Regulatory Authority (NMDRA) under the Minister of Health but outside the departmental structure of the Ministry. The initial draft done in the 2007-2009 period had clearly outlined an independent structure for the new regulatory authority but that draft mysteriously disappeared—obviously through the influence of multi-million dollar vested interests. The new draft has totally changed this structure and proposes an authority merely to endorse the work done by the existing Drugs Regulatory Authority, the professionals say. According to the new Bill, the NMDDCRA is only a Board of Management with a Chief Executive Officer but the structure of the authority is not spelt out. The proposed new authority is only a matter of changing the name of the present authority and it will come under the purview of the the Director General of Health Services. Hence, the new Bill continues to have the actual drug regulatory work within the existing system without handing over to the proposed independent authority. This is a clear violation of the national policy and an attempt to mislead the nation by claiming a new authority is being established.
The professionals have urged the Health Minister to present this Bill for public debate and comment and to rectify the major errors through a dialogue. The professionals say that they have shown only a few of the fundamental flaws in the Bill and there are many more which need to be corrected if this Bill is to achieve the aim of restoring a health service where the well-being of the patients is given top priority.
According to Prof. Bibile’s vision and the Essential Medicines Concept, Sri Lanka would be able to reduce the number of drugs being imported to about 1000 essential drugs. Today a record number of about 15,000 medicinal drugs are registered and the new Bill makes no provision to reduce the number. Prof. Bibile’s vision was for the prescription of drugs under their generic names with provision for a cost-effective brand name if the patient wishes to have it. The new Bill has no such provision for generic prescription. Prof. Bibile’s vision was for the State to have a monopoly in the import of drugs and for the State Pharmaceuticals Manufacturing Corporation to use Sri Lanka’s human and natural resources to produce hundreds of drugs locally, thus enabling the country to save millions of dollars in foreign exchange. The new Bill makes no such provision and thus health rights groups say it is a distortion of Prof. Bibile’s vision and an attempt to deceive the nation because even the Mahinda Chinthanaya of 2005 promised that the Senaka Bibile medicinal policy would be implemented.