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There are plenty of examples to show that the NMRA has been inadvertently perhaps, interpreted in a way that is disadvantageous to the pharmaceutical industry and by extension to the patients in Sri Lanka | (Pic courtesy 411w15.econ.lsa.umich.edu)

(Attorney-at-Law)
Vital medicines, of the type that could alleviate the suffering of patients who are under diagnosis for serious conditions such as cancer, and therefore need quick relief, for instance, have been withheld from the public due to the National Medicinal Regulatory Authority’s (NMRA) perhaps due to the misinformed implementation of the policies enumerated in the NMRA Act that was introduced early this year.

It appears that the NMRA officialdom cannot be entirely blamed.

The Act is in itself unfortunately riddled with contradictions. The Regulators for their part are not superhuman, and have not been able to easily negotiate the legal minefield of the Act. Either that or they are unable to interpret to everyone’s satisfaction the laws which are loosely worded in many places. In short, it could be safely said that individuals cannot be blamed for not being able to negotiate the legal morass.

It is interesting that the Act also states that any new medicinal drug that is put before its licensing arm, should be registered within a stipulated period of time.However, that stipulated period mentioned is never stipulated as for instance being two months, or two weeks !

For example, the Act states that need and cost for instance are among the criteria on which drugs are registered and licensed by the National Medicinal Regulatory Authority’s registering arm.

However, the World Health Organization’s policy is to be followed with regard to drug regulation, and this is part of the salient stipulations in the Act.

The WHO regulations state clearly that drug regulations should determine if drugs are efficacious and are safe and of good quality. Nothing is stated about price.

The NMRA has taken a different stand. ‘Need’ and ‘Cost’ are to be taken into account when drugs are evaluated for registration. (47 (3) of the Act.) Both such terms are steeped in subjectivity which could lead to flagrantly bad decision-making.

This is but one example of the NMRA Act being rather confusing and self-contradictory in places.

To dig further, it is interesting that the Act also states that any new medicinal drug that is put before its licensing arm, should be registered within a stipulated period of time.
However, that stipulated period mentioned is never stipulated as for instance being two months, or two weeks !! No time ending is given at all; leeway is given to the Authority to determine the said ‘stipulated period.’

This has left a great deal of discretionary power in the hands of the licensing arm of the Regulatory Authority. As a result, the regulators have a hard time using this ‘discretion’ and they don’t make it appear that their decisions are entirely arbitrary.

Arbitrary use of discretion however, has always got in the way of Rule of Law, and likewise has got in the way of fairness in administration.

The arbitrary use of discretionary powers leads to unfairness, and eventually to lawlessness and anarchy. Discretion suggests choosing one option from several without any pre-determined criterion. When the word ‘discretion’ is used in conjunction with the word ‘administrative’, its use becomes qualified. The exercise of discretion has to be with reference to the rule of reason and justice and not according to one’s personal whims.
To say the very least the laws in the NMRA document are being administered with little knowledge of the possible consequences.

It may be that the laws, perhaps, by themselves, lend towards arbitrariness, as they are often vaguely worded and leave too much room for interpretation.

But these are exactly the circumstances in which an abundance of caution should be the order of the day, to ensure fairness on all sides.

So far, as far as the NMRA Act and its enforcement are concerned, that is not happening.
In most foreign jurisdictions, there exists a void for vagueness proviso in the law, which compensates for vague or imprecisely worded provisions in well intended legislation.
The following example would be illuminating.

For instance, vagrancy is a crime that is frequently regulated by lawmakers despite difficulties that have been encountered in defining it. Vagrancy laws are often drafted in such a way as to encompass ordinarily innocent activity. In one case the Supreme Court of the USA struck down an ordinance that prohibited ‘loafing’, ‘strolling,’ or ‘wandering around from place to place’ because such activity comprises an innocuous part of nearly everyone’s life (Papachristou v. City of Jacksonville, 405 U.S. 156, 92 S. Ct. 839, 31 L. Ed. 2d 110 [1972])..

Though this was not in a Sri Lankan jurisdiction, this legal principle is solid and accepted in law.

If the laws are vague, as is the case in the NMRA Act under review here, the discretionary authority is not to be blamed for interpreting the laws, and indeed enforcing them in a way that might not be fair to one party. But something has to be done about this far less than satisfactory situation, and done fast.

It appears that, as in some of the examples indicated above, the NMRA has been inadvertently perhaps, interpreted in a way that is disadvantageous to the pharmaceutical industry and by extension to the patients in Sri Lanka.

By itself, that may not have been a problem for many people, except that despite the protestations of certain ‘purists’, very often what is unfair to the pharmaceutical industry translates as being unfair to the patients who are impelled to purchase vital lifesaving drugs and drugs for use in chronic care which are efficacious and safe. It would be superfluous to state that no patient would want to compromise on his own healthcare and would only want the best as would the Regulators if and when a need arises.

When drug evaluation for instance, takes into consideration efficacy, safety, quality, need and cost of each medicine, there is so much discretionary leeway that the legislation verily becomes a minefield.

But the NMRA Regulatory Act is exactly such a minefield stipulating that ‘need’ be taken into consideration when drugs are registered.

A cancer drug that may prolong life though not for too long, may not be considered a need by many people who think they are being objective about such a decision, but for a family that hopes for a medical cure that may be around the corner — at the cutting edge so to say — such a drug would be essential and should be accessible as per availability, and their ability to pay.

This is a subject that needs to be discussed at length, and a discourse should be opened up on every aspect of the Act and its viability as a regulatory instrument in particular, without people getting too emotional about their prejudices on this complex and multi-faceted but very important issue.