The pharmaceutical industry is brought under the microscope of the TISL

The recent procurements of medical supplies are under the microscope in the wake of a series of adverse events reported in the country over the past few months. Following severe allergic reactions among patients which even claimed a few lives, the use of certain batches of imported drugs has been suspended. With these developments, many concerns have been raised about the quality and safety of drugs imported to the country through emergency procurement processes.

In an email interview, Sankhitha Gunaratne, Deputy Executive Director of Transparency International Sri Lanka (TISL), highlighted that the failure to adhere to proper procedure is evident in the recent health sector procurements and that providing Waivers of Registration for pharmaceutical products imported to Sri Lanka has become a frequent practice.

Excerpts of the interview:

Q: Emergency procurements in the health sector have run into controversy recently. What are the corruption risks behind them?

Any procurement needs to be done in a transparent and accountable manner, following competitive bidding in as many situations as possible to get the best value for money. Obtaining good quality, efficacious and safe drugs and medical supplies for the best possible price should be the objective when it comes to health sector procurement.

If a procurement process is not competitive, that is if unsolicited proposals are given or the Government proceeds on the basis of single-sourcing, it raises a red flag on corruption.

In an emergency situation, of course, things need to be done fast, but it does not mean that we should settle for anything less than the best quality medication. Certainly, we should not settle for medication that can cause risks to people’s lives. These have become relevant both in the context of the COVID-19 pandemic and the economic crisis that followed.

Quality assurance is critical in the medical sector, as otherwise it can lead to mortalities, like what is happening in the country now.

A natural question that arises and a major allegation that is being made, is whether the single-source/unsolicited suppliers are in any way, politically or otherwise, aligned with those who have power, including the Health Minister or the Cabinet, to secure this kind of procurement. The level of discretion given to the Cabinet of Ministers in this kind of instance, especially in emergency situations, is too wide. This is a systemic problem in Sri Lanka’s procurement sector that needs to be addressed.

Q: Given the recent developments, what are the major concerns your organization has about the process followed when importing pharmaceutical drugs under the Indian Credit Line? Do you think the conduct of the National Medicines Regulatory Authority (NMRA) and the Health Minister has been appropriate in this instance?

Just because India with its Credit Line has, laudably, provided support to Sri Lanka, it does not mean that we can do away with proper procedure. Even emergency procurements have to follow due process and should ensure that quality is not compromised. One major way to address this risk is to have absolute transparency around the process that is followed.

Even though the Indian Credit Line binds us to obtain the relevant goods and medical supplies from the Indian market, it does not stand to reason to say that only one or two suppliers exist to make a bid on particular drug supplies. We all know that it is a huge market, a market that has been supplying to Sri Lanka for many years. Therefore, getting drugs from unregistered companies or getting unregistered drugs can only be justified in exceptional situations.

The bigger problem here seems to be that Waivers of Registration that are granted by the NMRA have become commonplace. It seems that the NMRA has been reduced to a rubber stamp when in reality, the burden upon that institution in that situation is to ensure that the lives of the Sri Lankan people, who would consume those drugs, are in safe hands. Waivers of Registration should only be granted in exceptional circumstances. Currently, however, the NMRA not only grants such waivers, but specifically states that it does not take responsibility for the quality and efficacy of such drugs. This is unacceptable.

The NMRA has a responsibility to ensure that Sri Lankan people are not administered drugs that are of low quality and are possibly life-threatening or causing chronic or dire consequences. In this situation, the NMRA needs to adequately apply its mind to the question of quality assurance and standardization.

As a watchdog organization on corruption, we believe the Health Minister and the authorities have to act with responsibility and transparency. They must be willing to be accountable to the people for their actions. Making more information public, would also allow them to prove their innocence to the public, if there has been no irregularity in the process followed.

The committee appointed to look into the recent incidents of drug allergies reported in several hospitals points to a conflict of interest because the appointments have been made by the Health Minister himself, whose conduct has also been questioned in this instance.

The Government should not, in any instance, attempt to bypass Sri Lanka’s procurement process. We have to ensure that our domestic laws are followed to the letter even in emergency contexts.

Q: As a corruption watchdog, what action has your organization taken with regard to the recent developments involving emergency procurements in the health sector?

TISL has already gone to the Supreme Court because of allegations that were made and information that came to light about possible corruption within the procurement that took place through the Indian Credit Line from a company called ‘Savorite Pharmaceuticals’. It was done as early as February this year, naming 47 Respondents, including the Cabinet of Ministers, the Health Minister, and the NMRA.

This case, filed in the public interest, challenged the role of the Cabinet of Ministers in procuring medical supplies through unregistered private suppliers, the role of the NMRA in providing Waivers of Registration to procure medical supplies from unregistered suppliers, non-compliance with procurement guidelines and abuse of process by the Health Minister and the Chief Executive Officer of the NMRA.

Supreme Court, while granting leave-to-proceed in the Fundamental Rights (FR) petition on April 6, issued an interim order suspending further imports of pharmaceuticals from ‘Savorite Pharmaceuticals’. The Court also issued a second interim order that the quality and safety of the drugs which were imported at the time should be proven through tests conducted by an independent party.

These interim orders were given on the basis that there was a prima-facie case to show that the proper procurement procedure has not been followed and that there was no assurance of the quality and efficacy of drugs obtained through that entity. The matter will be gone into detail in the coming months.

Q: How does your organization recommend tackling corruption and improving transparency in the health sector procurement?

In the medium to long term, we highlight that the existing procurement guidelines and related laws in Sri Lanka need to be updated, simplified and consolidated, possibly as one ‘National Procurement Law’. Currently, there is no law on procurement, thus these guidelines should be converted into a law.

Guidelines and laws should not be too technical, and citizens must have access to relevant information through online means, so that citizens and watchdogs can monitor whether corruption or corruption risks exist within procurements in general, and specifically, in the health sector.

The current procurement process is mired in opacity. It takes place through several administrative levels, and does not truly ensure a process that is accountable. It cannot be easily challenged because a lot of it takes place hidden in bureaucracy and behind closed doors. As a result, there is space for vested interests to come into play and for corruption to take place.

We also need to shift to an e-procurement system that would allow citizens to have more access to information related to procurements as they happen, beyond what the currently available platform “promise. lk” facilitates. This would allow citizens and third parties to monitor whether they truly get the best value for money. Transparency is necessary to ensure that we do not bleed out public resources for the personal gain of a few.