HEALTH, EDUCATION AND YAHAPALANA Part 7
Posted on September 21st, 2019

KAMALIKA  PIERIS

DRUG SHORTAGE

Doctors held media conferences on 1.8.19 and 2.8.19 to inform the public of serious shortage of drugs. This was shown in television news. The doctors said that there were drug shortages at many hospitals. They included Ampara, Anamaduwa, Balapitiya, Chilaw, Galle, Kandy, Karapitiya, Kegalle,  Mahiyangana Matara Naula, Puttalam and Ratnapura.

Lists of the drugs in short supply were shown. There was a shortage of 36 drugs at Matara general hospital, 30 at Anamaduwa and 15 at Kegalle. They included drugs for diabetes, asthma, heart disease urinary infection and emergency medicine, several cancer drugs were in serious shortage. Cancer hospital, Maharagama lacked a drug that was needed for cancer patients who could be cured.

There are two reasons for drug shortages, the doctors said. Firstly, drugs are bought when they are nearing the expiry state. After some time, these drugs are discarded, but by then about 90% of these drugs have been given to the patients. In 2015, there were 1334 ‘no objection’ letters issued by the Health Ministry, permitting such drugs to come in. secondly the drugs are of poor quality and have to be discarded. Health Ministry, however, denied that there was a drug shortage in hospitals.  The Ministry also said that when a hospital runs out of a drug, it is permitted to purchase from private sources.

DRUG PURCHASES (1) Trastuzumab

A tender awarded by Cabinet for the supply of 1,875 vials of Trastuzumab to the lowest bidder, has aroused concern. Conditions that were not part of the original bid document have been imposed after the tender was awarded. State Pharmaceuticals Corporation had introduced a new condition of pre-shipment sample testing at TGA-Australia, which would take three to four months.

Ministry of Health, when told this,   had directed that no new conditions should be included in the contract. This was ignored. The new specifications included the new condition of TGA laboratory testing.

GMOA said this was a “delaying tactic”. There are ongoing moves to offer a 15-year ‘buyback guarantee’ for the product. This was an attempt to buy time until the ‘buyback guarantee’ agreement was pushed through. Big fish’ were involved in this matter.

 The price quoted by the supplier for Trastuzumab is Rs. 95,500 + 20% per vial totaling Rs. 115,000 with the ‘buy back’ price. This would translate into a staggering Rs. 50 billion loss to the country. When there are many globally accepted products offered at more competitive pricing, why should a ‘buy back guarantee’ be given to a Russian product which is not accepted world-wide, asked the doctors.

The ‘buy back guarantee’ spanning such a long period will   deny a level playing field to other stakeholders. It will   shut out new technology, modern drugs to treat cancer patients in Sri Lanka. It will also jeopardize the lives of cancer patients by creating a monopoly to allow a single supplier to import the substandard Russian drugs at relative higher market prices through a 15-year ‘buy back guarantee’. 

This purchase has   come before the Presidential Commission probing corruption  in Yahapalana government.  Oncologists told the Commission that 85% of patients in the country are being treated for early stage breast cancer and therefore an effective drug was needed.

 Oncologists  rejected the Russian made Trastuzumab and Bevacizumab drugs as they remain unproven in terms of clinical efficacy and safety.  For the registration of a drug, a Certificate of Pharmaceutical Products (COPP) is issued by an institution affiliated to the Health Ministry in a country. However, in the case of Trastuzumab, this certificate has been issued by the Industry and Commerce Ministry of Russia. 

The pharmacist who evaluated the Russian drug told the Commission that the product didn’t fulfill many basic regulatory criteria. Among them were the minimum six months stability of the product. The product was launched in Russia in January 2016 and registered in Sri Lanka in February 2016. 

There was also the requirement to have at least three exporting countries. This was totally overlooked. The Russian manufacturer also did not have the basic WHO GMP.  The Russian manufacturer had withdrawn its Indian operations due to possible quality concerns,  said  critics. 

DRUG PURCHASES (2) Flucloxacillin

A  tender for importing 25 million capsules of Flucloxacillin was called in May 2018. The Medical Supplies Division informed the SPC that there was a pressing need for the antibiotic. The tender had been awarded to a company quoting almost double the price of the cheapest bidder. Thereby causing a loss of more than Rs. 70 million to the state.

There were four bids by three companies, Orient, Microlabs and Pharmace. Orient and Pharmace were both going to import the drug from Bangladesh and  there was no difference in quality, either. But for a card of 10 capsules, Orient quoted Rs. 37 while Pharmace quoted Rs. 68 .

The Technical Evaluation Committee (TEC)   rejected Orient, for having a low bid bond, and Microlabs for not being a registered company, and awarded the tender to Pharmace although their quotation was almost twice as Orient’s.

This  tender came before Presidential Commission of Inquiry  investigating corruption in the current administration. Commission found that Technical Evaluation Committee had used non-existing specifications to overlook the bidder who had quoted the lowest price

Orient’s bid had been rejected because it had not provided 2% of the estimate cost as the bid bond, a guarantee that the bidder will undertake the contract if selected, and because they had not quoted the price for the ‘pack size’ that the Ministry wanted.”

“The estimated cost was Rs. 225 million and Orient had not given 2% of the estimate cost as the bid bond. Moreover while the specifications said that the pack should comprise 10 capsules in a card, Orient had listed another amount, said the  TEC.  

The Commission wanted the head of the TEC  who was also a  Deputy Director of Health to show the section  in the bid document, where the estimated cost and pack size was   stated. He could not do so, but instead presented a letter sent by the State Pharmaceutical Corporation  to the Ministry, stating that the estimated cost was Rs. 225 million. The witness also  failed to find the relevant sections of the bid document on the pack size.   He could  not show that these specifications  had been communicated to the bidders, either.

The Commission observed that since there was no evidence to suggest that the  bidders had been informed about estimated cost and  pack size, it would have been absurd to expect  a response from the bidders.

APPOINTMENTS (1) 

Supreme Court has given two historical verdicts” regarding two inappropriate appointments made by the Health Minister,  announced GMOA in May 2019. The two verdicts had been given in connection with appointments made by the Health Minister for the posts of the National Medicine Regulatory Authority (NMRA) Chairman and the Chief Executive Officer. Supreme Court had given a similar verdict in connection with the inappropriate appointment made by the Health Minister for the  Director, Sri Jayewardenepura Hospital.

APPOINTMENTS (2)

GMOA said, in a media statement, in July 2019 that there had been a delay in appointing Intern Medical Officers and that had caused a major crisis in the health sector.”This has stopped a lot of medical students who have completed their education from starting work. It also affects patients because the delay in appointing Intern Medical Officers will lead to a shortage of doctors. Moreover those who have completed their intern appointments still have to continue in their present stations for want of replacements.”

The final year examinations of all state medical faculties have been conducted and results issued. The Act 16 examination for foreign medical graduates has also been conducted. There are people who have passed these exams and are waiting to start their professional career.”

GMOA charged  that there was a ‘plot’ to appoint medical graduates of South Asian Institute of Technology and Medicine (SAITM) and a number of foreign graduates who had failed GCE A/L, as intern medical officers. We insist that intern appointments should be given only to medical graduates recognized by the Sri Lanka Medical Council.  We will oppose any attempt to appoint SAITM and foreign graduates to these intern positions.

GMOA STRIKE

The Government Medical Officers’ Association (GMOA) announced that would launch a 24-hour strike on  22.8.19 . The strike is on account of eight issues  that relate to medical matters. GMOA  said it is  not demanding any salary increases but is launching this strike in the public interest.

There are several reasons why we are going on strike, they said.  Among them are drug shortages in hospitals and the substandard drugs given to patients, the attempts by the Minister to appoint persons who had failed all three subjects at GCE A/L as doctors, for not passing laws specifying the minimum standards for medical education,  attempts to weaken the Sri Lanka Medical Council through new regulations, delaying post intern appointments  and against the actions of the Health Minister, which they alleged were destroying the health sector. GMOA also observed that the politicisation of the doctors’ transfer scheme has led to a breakdown of services at rural hospitals.

The two main reasons for the strike, however, is the issue of not introducing the Minimum Standards of Medical Education and trying to amend the Service Minute of Doctors.  Health Minister should table the Minimum Standard of Medical Education in Parliament and stop the process of amending the ‘Doctors’ Service Minute’ with immediate effect, GMOA said.

Health Minister has not brought in the Minimum Standards of Medical Education because the standard  very clearly  gives the minimum G.C.E.Advanced Level Examination result of a student eligible to enter a medical faculty. It also gives the  physical facilities that should be in any medical faculty, the human resources that should be in any medical faculty and especially the required standard of any Teaching Hospital attached to any medical faculty. A Teaching Hospital is a must for any medical faculty.

The main objective of amending the existing Service Minute of Doctors is  to enable unqualified individuals to enter the public service as MBBS doctors. At the moment it cannot be done because of the rules and regulations of the Doctors’ Service Minute,” GMOA said.

The GMOA has the list of unqualified individuals who have failed all three subjects in the GCE Advanced Level Examination in the Science Stream and want to become MBBS doctors. It also has the list of names  of those who had not studied in the Science stream in G.C.E.Advanced Level Examination,” GMOA added.

MINISTER OF HEALTH

Rajitha is the worst Health Minister we have had in our history,   said the GMOA   at a media conference in August 2019. The public seem to agree. When Senaratne went to open a facility at District Hospital, Negombo in June 2019, the public were waiting to accost him, complete with placards. Senaratne left by a back door. The   angry public then chased after the cars of the officials who left by the front entrance. Television news showed this.

Members of the Government Medical Officers’ Association  of the Kandy Teaching Hospital staged a lunch-hour protest  in June 2019 demanding the removal of Health Minister Dr. Rajitha Senaratne from his post. The demonstrators displayed posters carrying accusations against Minister Senaratne. Rajitha Senaratne had no moral right to hold the Ministry of Health as there were so many allegations of corruption against him,  they said.

GMOA  sought an explanation from the World Health Organization in June 2019 as to why Health Minister Dr. Rajitha Senaratne had been granted the title of Vice President of its Executive Committee.  The GMOA drew the attention of the WHO to  two specific issues. importation of low quality cancer drugs not certified by the WHO and the allocation of public funds amounting to nearly Rs. 5 billion to Neville Fernando Hospital, which the state has not  yet acquired. 

GMOA also brought to the WHO’s notice recent threats to the GMOA and the decision to lodge complaints with police headquarters in that regard.  GMOA  pointed out that Dr. Senaratne was engaged in such activities while identifying himself as the Vice President of the WHO.

Further,  Dr. Seneratne has  brazenly used the title given by the WHO, in support of personal political projects, including an ongoing image building exercise. The GMOA has sought a clarification from the WHO Country Office in Colombo whether it had funded an event held in Colombo to celebrate Dr. Senaratne’s achievements. GMOA raised this issue because Senaratne had said in Parliament that the event was sponsored by the WHO.

The GMOA sent copies of its complaint to WHO Geneva,  to the President’s Secretary, to the PM’s Secretary, Health Secretary and Director General Health Services. The GMOA has sought an urgent meeting with the WHO to make further representations on the issue. (CONCLUDED)

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