bY SURESH PERERA
Amidst flak from the pharmaceuticals industry over the move by the regulatory watchdog to call for the cancellation of registration and import licenses of 10 drugs imported by five companies for “arbitrarily and unilaterally increasing their retail prices”, Prof. Asitha de Silva, Chairman of the National Medicines Regulatory Authority (NMRA) says there is no need for a regulator if anybody can bring medicines, sell at whatever prices they want and increase prices whenever they want.
“In terms of the regulatory provisions, we not only look at the safety, quality and efficacy of drugs, but also the key aspect of affordability”, he outlined in the backdrop of the pharmaceutical industry’s representative body slamming the regulator for displaying, what it termed, “a dangerous, discriminatory trend by selectively issuing cancellation notices”.
What the NMRA has done is illegal because the 10 imported products concerned do not fall within the ambit of “price-controlled essential drugs”, protested Ms. Kasturi Wilson, President of the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI).
How can the NMRA claim the importers had violated price regulations by “arbitrarily and unilaterally increasing their retail prices” when the regulator has authority only over 74 essential drugs within the price control mechanism?, she queried.
Under a gazetted order, the prices of all medicines are regulated and cannot be increased willy-nilly, Prof. de Silva clarified. “To claim there’s no price regulation on all medicines is patently false”.
Can anybody assert that one medicine is more useful than the other, depending on the illness of a patient under treatment?, he asked.
In 2015, the Supreme Court made an observation that affordability was key to patient centric medicines and NMRA’s function and duty should be to make medicines affordable to the common man, he recalled.
“Under Section 3 of the NMRA Act, we have wide powers to regulate prices of all medicines with the objective of bringing them within the reach of the public”, de Silva continued.
What the importers of the drugs did was to marginally adjust prices, which was inevitable due to the challenging situation of the Rupee vs Dollar depreciation, Ms. Wilson explained. “They didn’t even take into account the manufacturing cost fluctuations”.
“If there was an adverse impact due to currency fluctuations, they should have discussed the issue with us without arbitrarily increasing prices of drugs”, the NMRA boss reasoned.
On July 17, 2020, the NMRA issued notice calling for the cancellation of registrations and import licenses in relation to 10 specific drugs imported by Hemas Pharmaceuticals (Pvt) Ltd., (trade name of medicines: Zeos 10mg, Herbesser 100mg, Xon Ce), A. Baur & Co (Pvt) Ltd., (Rivotril 0.5mg & 2mg, Calcivita), Euro Asian Pharma (Pvt) Ltd., (Levitoz 5mg, Dozil 5mg &10mg), Pettah Pharmacy (Pvt) Ltd., (Daktacort cream) and Robert Hall & Co. (Pvt) Ltd., (Betadine cream), for “violating conditions of registration”.
In issuing notice, the NMRA said the arbitrary increase in the price of drugs in violation of conditions of registration will cause much hardship to patients, especially in the background of the ongoing Covid-19 pandemic. Therefore, punitive action has been taken against offending companies under powers vested with the Authority to ensure affordability of medicines available to the public.
The NMRA has not canceled the registration and import licenses of the five pharmaceutical companies so far. With notice issued, they can make their submissions for consideration, the Chairman elaborated.
There is no stated condition either in the primary registration certificate, the renewal registration certificate or in any associated existing document or communication that a price increase cannot be made, the SLCPI asserted.
The SLCPI is merely trying to fall back on one line in the regulatory framework and use it to its benefit. Taken as a whole, the NMRA is legally empowered to regulate prices of all medicines, the senior Professor of Pharmacology further said.
At a time there is a global shortage of Vitamin C, one of the importers has been taken to task for adjusting the price of the product Xon Ce, Ms. Wilson noted. “The NMRA should be conscious of the plunge of the Rupee against the USD, and the serious situation of shortages globally caused by the Covid-19 pandemic”.
“Our top priority is to ensure a continuous supply of drugs to patients”, she stressed, while adding that if there is a disruption, the products will be brought down through unauthorized channels and sold for double or treble the original prices.
Under the circumstances, the industry was compelled to do some marginal price adjustments to prevent any shortages of these drugs in Sri Lanka, she elaborated.
What is the use of the NMRA Act passed by Parliament if importers can arbitrarily decide on pricing?, de Silva asked. “Only a few countries has a unique piece of legislation on these lines, which deals not only with safety, quality and efficacy but also on affordability of drugs”.
“We investigated consumer complaints on arbitrary price increases. For example, it was found that the price of a certain medicine sold at Rs. 700 in January this year was pushed up to Rs. 960 by July – within just six months”, he said.
When the unauthorized price revisions were taken up with the importers, a letter was received saying, more or less, that “it’s none of our business”, the NMRA chief added.
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AG not bound by its recommendations, yet to receive report
PCoI on Easter Sunday attacks:
By Shamindra Ferdinando
Attorney General Dappula de Livera, PC is not bound by recommendations made by the Presidential Commission of Inquiry (P CoI) into the 2019 Easter Sunday carnage, or presidential directives in that regard, according to authoritative sources.
They said that the AG couldn’t under any circumstances initiate legal proceedings until he had received the full PCoI report.
President Gotabaya Rajapaksa received the PCoI report on Feb 1. The President’s Office delivered a set of PCoI reports to Speaker Mahinda Yapa Abeywardena on Feb 23, a day after the report was presented to the cabinet of ministers. The Island raised the matter with relevant authorities in the wake of a section of the media reporting the PCoI recommending punitive measures against former President Maithripala Sirisena, Defence Secretary Hemasiri Fernando, IGP Pujitha Jayasundera, Chief of State Intelligence Senior DIG Nilantha Jayawardena, Chief of National Intelligence retired DIG Sisira Mendis and All Ceylon Makkal Congress (ACMC) leader and Samagi Jana Balavegaya MP Rishad Bathiudeen et al over the Easter Sunday carnage.
Sources pointed out that due to the inordinate delay in sharing the PCoI report with the AG, the department hadn’t been able to take preliminary measures required to initiate the proceedings. Sources said that a team of officers would take at least six weeks or more to examine the report before tangible measures could be taken.
With the AG scheduled to retire on May 24, 2021, even if the AG Department received the P CoI it would be quite a tough task to initiate proceedings ahead of retirement, sources said. However, in terms of the 20th Amendment to the Constitution enacted in last October, both the AG and the IGP could receive extensions beyond 60 at the President’s discretion.
Dappula de Livera received an Acting appointment as the AG a week after the Easter Sunday carnage whereas his predecessor Jayantha Jayasuriya, PC, was elevated to Chief Justice.
Responding to another query, sources said that the Attorney General two weeks ago requested Secretary to the President for a copy of the P CoI. However, the AG was yet to receive one, sources said. In spite of the AG not receiving a P CoI copy, the AG had instructed the IGP to obtain a copy of the report when he requested the police to complete investigations into the Easter Sunday carnage. The AG issued specific instructions after having examined police files pertaining to the investigations.
The IGP, too, hadn’t received a copy so far though some sections of the report were in the public domain.
Agriculture Minister Mahindananda Aluthgamage displayed at a live political programme on Derana a copy of the P CoI report he received at the cabinet meeting earlier in the day.
Sources said that the Attorney General’s Department couldn’t decide on a course of action in respect of the Easter carnage on the basis of a section of the report. In terms of the Commission of Inquiry Act (Section 24), the AG enjoyed significant powers/authority in respect of investigations; sources said adding that the Department urgently required both the P CoI report and police investigations report. The Attorney General’s Department has raised the delay in receiving a P CoI report amidst the Catholic Church attacking the government over the same issue.
Sources said that ministerial committee appointed to study the P CoI report couldn’t decide on how to proceed with the recommendations and the matter was entirely in the hands of the AG. Sources pointed out that the delay on the part of the government to release the report had received the attention of sections of the international media, including the New York Times. Public Security Minister retired Rear Admiral Sarath Weerasekera having met Malcolm Cardinal Ranjith at the Bishop’s House on Dec 8, 2020 said that the AG would get a copy of the P CoI report once the President received it. Minister Weerasekera said that the CID had handed over the relevant files after having completed investigations into eight blasts. Referring to the Parliamentary Select Committee (PSC) report on the Easter Sunday carnage, the former Navy Chief of Staff said that all such documents would have to be brought to one place and considered before initiating legal proceedings. Acknowledging that there could be delays, lawmaker Weerasekera said that on the instructions of the Attorney General a 12-member team of lawyers was working on the case. The minister vowed to expose the mastermind behind the Easter Sunday attacks. Investigations continued while some of those wanted were overseas, the minister said.
The minister acknowledged that the Attorney General couldn’t proceed without the P CoI report. Minister Weerasekera reiterated that once the President received the P CoI report, it would be sent to the Attorney General. The minister said that there were documents two to three feet high that needed scrutiny. The minister assured comprehensive investigation. The minister said that investigations pertaining to eight blasts had been completed and the reports handed over to the AG. However, the Attorney General had found shortcomings in those investigations.
JVP picks holes in PCoI report
By Saman Indrajith
The Presidential Commission of Inquiry on the Easter Sunday bombings had failed to identify the mastermind of , the JVP said yesterday.
Addressing the media at the party headquarters in Pelawatte, JVP Propaganda Secretary MP Vijitha Herath said that the PCoI report had levelled accusations against former President Maithripala Sirisena, former IGP and head of intelligence for their dereliction of duty, shirking of responsibilities and not taking action to prevent the attacks and negligence. There were reference to the causes of the terror attacks and actions to be taken to avoid such attacks and the influence of extremist organisations. “However, there is no mention of the mastermind of the attacks, the handlers of the attackers and those whose interests the carnage served. It is also not mentioned whether there has been any foreign or local organisation behind those attacks. As per the PCoI report the attack took place as a result of culmination of extremism.
“According to the PCoI the extremist activities were a result of the prevailing political situation then. The entire nation was waiting to see who was responsible and who masterminded those attacks. The PCoI has failed to identify the true culprits responsible for the terror attacks. The report says that the leader of the suicide cadres killed himself in the attacks and it was a puzzle. That means those who are actually responsible for the attacks are still at large. The report does not provide exact details of the sources of the attacks. The PCoI had sittings for one year and five months. It summoned various persons and got their statements but it has failed to shed any light on the terror attacks. Everybody knows that the top leaders of the government and heads of security and intelligence establishments failed in their duties. Ranil Wickremesinghe was the second in command and he too is bound by the responsibility but the PCoI report fails to identify him as one of the persons against whom legal action should be instituted. The PCoI has treated Wickremesinghe and former President Maithripala Sirisena differently. We are not telling that this report is a total failure but we cannot accept this as a complete report. The PCoI handed over its report to the President on Feb 1. After 23 days it was sent to Parliament. Now, a copy of the report is there in the parliamentary library for the perusal of MPs.”
Herath said that the PCoI did not have powers to take punitive action. “It only has powers to name those responsible and recommend action to be taken against those named.