NMRA appointments draw mixed reactions

by Carol Aloysius

Last week’s appointment of Prof. Asitha de Silva and Dr Kamal Jayasinghe as the new Chairman and CEO of the National Medicines Regulatory Authority ( NMRA) which replaced Prof. Lal Jayakody and Prof. Chrishantha Weerasuriya, has drawn both brickbats and bouquets, with at least one organisation threatening to challenge the appointments in court.

The central figure of the controversial appointments, Prof. Asitha de Silva when contacted by the Sunday Observer, was in a mood to talk candidly. To our initial query, he confirmed he had accepted the new post as Chairman NMRA and begun duties in that capacity from Monday (June 20). The Oxford trained clinical pharmacologist who has 24 years in academia of which 12 was as Professor in Pharmacology, at the University of Kelaniya., commenting on his initial reaction to the offer, said , “ When I was given this offer, I thought about it and asked the Vice Chancellor of the University where I teach, and who is my boss, for his advice. After seeking legal advice, I submitted a letter outlining the details of my professional services. However, due to what was perceived as a conflict of interest, I decided to resign completely from RemeduimOne a private research company established as a public private partnership with the Kelaniya University.” He added, “ This is nothing new or unique in Sri Lanka .We already have one such example at the University of Moratuwa. In fact, the National Research Council encourages this kind of research strongly”.

Asked if he had been coerced into resigning from this company, he replied in the negative, reiterating it was due to the perceived conflict of opinion “.

Senaka Bibile

Responding to a question on whether he was committed to Professor Senaka Bibile’s Drug Policy he said, “ Absolutely. However, making affordable, safe drugs available to all is a challenging task which cannot be solved with mere lip service. However, I can see it becoming a possibility in the near future, perhaps two to three years ahead – if we all work hard and engage all the stakeholders to work together for this common cause”.

He said the Health Ministry had begun addressing this problem by ensuring private enterprises to work with the State Pharmaceutical Manufacturing Corporation (SPMC) to manufacture quality drugs. In addition, it has also invited foreign collaboration requesting any country that has the proper technology and are happy to invest here, to do so.

Health Ministry comments

While Director General Health Services, Dr P.G. Mahipala refused to comment saying the subject was not within his purview Secretary, Ministry of Health, Nutrition and Indigenous Medicine, Dr Anura Jayawickrama was more forthcoming. Confirming that the former Chairman and CEO had resigned on their own, he acknowledge that both were well recognised professors with sound track records. He said, the issue was the large backlog of outstanding cases that had not been settled expeditiously.

“We can help the new management to sort out these issues and have already made some moves in that direction, by getting down safe affordable drugs from other countries to bridge any immediate shortage:. ”, he said, adding , “ We will ensure they are quality drugs”.. Sources at the Medical Drugs Supplies Stores of the Health Ministry said new technology to transfer information about drug status using the hospital network would further facilitate the proper distribution of drugs in all state hospitals and clinics, at the peripheries and in the cities and towns.

“Asked about the controversy with regard to Prof. Asitha’s link to the private/public company RemediumOne , he said, “ He has already resigned from that company, so there is no issue now”.

Prof. Lal Jayakody

Former Chairman Prof. Lal Jayakody in a telephone interview spoke frankly, brushing aside the personal accolades showered on him and his colleague Prof. Chrishantha Weerasooriya by various members of the medical community including some leading newspapers and television companies.

Pointing out that he was still a member of the NMRA as a professor of Pharmacology of the University of Colombo, he seemed resigned to accept his sudden dismissal, to karma, ‘ Change is a part of life and we have to accept that” he said. Asked if there had been complaints as alleged, with regard to his performance, he said, “ I held this post of Chairman for eleven months during which time no one sent me any complaint in writing about any major issues except general issues. Asked about tender issues, he said the Authority was not involved with calling for tenders and that tenders from the Health Ministry for drugs came directly under the Medical Supplies Division. On drug shortages linked allegedly to mismanagement under his regime, he said, “ We have always had drug shortage problems, which may vary with the type of drugs and amounts needed.. e.g. If the country runs short of thyroxin or insulin these become issues as they affect a comparatively smaller number of persons. But, we can always replace or get them down if they are really needed, from abroad. After the recent floods I remember there was a shortage of 2-3,000 drugs and equipment especially when some drug stores went under water, but we were able to replace them . It was an astronomical job which was executed by all our health staff. “

Asked if he would continue working in the field , he said, “ I have been Senior Professor in the University system since 1989 and have helped voluntarily in the drug business to ensure good, affordable, quality, safe drugs. I will continue to do so, in whatever capacity till my retirement which is just 1 ½ years away. As for the new management, it would not be right for me to comment. But let’s be optimistic.”

PMRP

Meanwhile the People’s Movement for the Rights of Patients (PMRP) has decided to strike back and challenge the new appointments. With enough legal armour to back their charges, senior sources from the organisation speaking on grounds of anonymity, told the Sunday Observer, “ Our plan is to go to courts and challenge these appointments as contravening No 5 section 5 of the NMRA Act, which states that members of the Board should not have conflict of interests.”

Acknowledging the fact that both professors were eminently qualified , they said their objection was that Prof. Asitha de Silva was also the Director of a private /public research company dealing with pharmaceuticals.

“This is a violation of the NMRA Act which states under Section 5 Act 5 that, “ persons appointed as chairperson/member to the NMRA should have no conflict of interest in affairs of the Authority, or engage in any employment or assignments in the pharmaceutical trade within a period of three years immediately before taking up the position, or after such a person ceased to be a member of the Authority”.

PMRP sources also rejected charges on the inability of the former Chairman and CEO to perform their duties well. Quoting the Health Minister as making such a statement, they asserted that both of them had done a commendable service in their brief tenure of office and had in the process resolved serious issues for the public benefit.

They said Prof. Lal Jayakody had several times refused permission to suppliers of drugs to bring down certain unwanted drugs thus saving the country much foreign exchange. They reiterated Prof. Lal Jayakody and Prof Chrishantha Weerasooriya were , “persons of the highest integrity who told us they resigned because they were under pressure and not allowed to work independently. They expressed fear that, “ Transnational pharmaceutial companies can undermine the quality and affordability of drugs which Prof. Senaka Bibile wanted, if strict monitoring measures are not put in place immediately”.