Health Minister Maithripala Sirisena, addressing a huge meeting in his home base of Polonnaruwa to mark the 25th year of his work as a parliamentarian, thanked the people for enabling him to do so much for the country with one of the great achievements being the presentation of an Act in March to provide for the establishment of a regulatory authority which shall be responsible for the regulation and control of the import manufacture and other matters relating to medicinal drugs.

While thanking and congratulating the Minister for his struggle to present this 84–page Act, we would like to point out to him some major flaws where some vested interests appear to have diluted vital clauses in the comprehensive draft for the national medicinal drugs policy approved by the Cabinet in October 2005 as a first important step towards restoring a health service where the wellbeing of the patients is given top priority.

Pharmacologists and health rights experts who gathered at a meeting organized by the People’s Health Assembly (PHA) last Friday, said the Act should reflect the thinking behind the NMDP approved in 2005 by the Cabinet.  One senior pharmacologist said the proposed Act went against the main principle of establishing an independent National Medicinal Drugs Regulatory Authority (NMDRA). A standing committee comprising all stakeholders was to be established to define and regularly update the national essential medicines list. It was to formulate, review and update standard treatment guidelines, drug index, the Sri Lankan formulary and Government drug procurement documents. Regulation, quality assurance and implementation of the policy were to be done by the standing committee. But all these procedures have been left out of the proposed Act.

Instead, a National Drugs and Devices Regulatory Authority limited only to a Board of Management is to be set up under the proposed Act. The structure of the Authority has not been mentioned. All functions are to be carried out by a small unit as at present. One of the functions of the standing committee, as proposed in the original draft was to regulate clinical trials. There is no mention of this in the proposed Act.
According to the original draft, all members appointed to the NMDRA should declare conflict of interest statements before accepting the appointment and declare the same every six months during their term in office. These declarations should be publicly available in the NMDRA and the Health Ministry websites. This needs to be incorporated in the proposed Act.

In terms of the proposed Act, the Chairman of the new Authority will be appointed by the Minister of Health, and this is not acceptable as he or she will be a political appointee. Thus the independence of the Authority will be compromised.
What are the minimum criteria to be an Executive Director of the Authority? This needs to be defined in the annexure. The term “Qualified in the field of medical administration” is vague. The maximum number of re-appointments should be stipulated. It should be restricted to two terms.
The expert says the fines for offenders should be increased at least to Rs. 15 million. Prescriptions should be written in the generic names whenever a generic name is available and if a brand name is needed, it could be written within brackets. This is an already existing regulation from 1992.

The expert says the customer should have the right to ask for any generic or brand name instead of the brand name prescribed. The wording of the provision in the proposed Act violates this right. The first part of the section should be removed and the provision should stand as the pharmacist may dispense a generic, the written brand name or any other brand name with the consent of the buyer.
All drug regulation activies and authority should be with the new authority. There should not be a separate division in the Ministry under the Director of Medical Supplies and Technologies. This is violation of the policy adopted in 2005.

If there are two separate entities, the chain of command of drug regulation can get into unnecessary confusion, and the expert feels this has been done to undermine the new regulatory authority.
We hope the Health Minister will consider these and other changes because the Act he has presented should not be portrayed as Senaka Bibile policy which dealt with much larger issues in a comprehensive manner and encompassed a much wider vision than seen by the current piece of legislation.