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Medicine Availability and the Role of Regulators

Medicine Availability and the Role of RegulatorsAbia 2017 in the life of Pharmacy practitioners and allied professionals and stakeholders, was a turning point regarding how the role of regulatory agencies should affect medicine availability, or even the lack of it. It was really an eye opening experience as the complex issue – Regulatory perspective in medicine availability was adequately dissected by a panel of discussants at a plenary session chaired by Sir. Anthony Akhimien, a fellow of the Pharmaceutical Society of Nigeria.
But beyond all of these is the practicality of the issues raised. Or, will this just pass as one of those talk shops? The crux of the matter according to experts and industry watchers alike is and has always been that of policy implementation or enforcement of the requisite laws. Some, if not all of these laws or regulations on the overall, bother on the issue of national security – just as the theme of the just concluded 90th Annual Confab of the Pharmaceutical Society of Nigeria (PSN) in Umuahia goes: “Medicine Availability and National Security”.
Taking the issues apart, analysts have been able to lay the cards (bare) on the table; regulating and controlling the practice of pharmacy as well as the need for enforcement of the provisions of the law, is germane and central to the sustenance of any meaningful healthcare and ‘security’ for the general populace. Some of the regulatory matters that come up for attention many at times include: Code of ethics for pharmacists, drug regulation and control, registration of pharmaceutical premises, poisons and pharmacy act, Drug guidelines, and NAFDAC guidelines for clearance of imported chemicals, etc.
But according to Pharm. Oladipo Popoola – also a fellow of the Pharmaceutical Society of Nigeria, extreme caution must be applied in the bid to regulate pharmaceutical products so as not to cause an unintended adverse reaction or interaction in the line of trying to make (quality) medicines available to the end user.
He says in the bid to carry out their statutory functions, the regulatory bodies must bear it in mind that, “we have to regulate, but we must not over-regulate …” He believes that if regulation is carried out overzealously, it will definitely lead to scarcity of pharmaceutical products. Popoola states that a line must be drawn between regulation and the ease of doing business so as to ensure drug availability.

In the opinion of Pharm. Peter Iliya, Deputy Director – Public Relations of PCN, ensuring security in the pharmacy landscape does not necessarily connote the use of ‘military’ force, and so he calls for extra caution as well. But why is the hullabaloo about the use of force anyway?
It is an open secret that both the law enforcement and regulatory agencies have somewhat become overwhelmed by the nefarious activities of drug fakers, unscrupulous importers, as well as the growing breed of drug addicted youths – all of whom are constantly devising new ways of beating the authorities. In the words of Mr. Akingbade Bamidele, an officer of the National Drug Law Enforcement Agency (NDLEA), “the youths have found new ways of getting high on stimulants.” He says for this reason these youths no longer have need to go looking for expensive hard drugs like cocaine, heroin or cannabis and the likes.
These young people have easy access to codeine, tramadol and the rest of them; they use them for the same purpose of getting high. Since cost is hardly a limiting factor, the new trend is fast growing into an epidemic proportion, and this is the current problem on the hands of the authorised regulators as well as healthcare professionals. Up north of the country, the state of this social ill has assumed an almost unimaginable proportion. To this effect Mr. Bamidele says the NDLEA is relating with the governments of Kaduna State, Kano, etc. in a bid to curb the frightening menace of drug abuse among the youth.

There is no gain saying that the Nigerian Customs Service occupies a strategic position in this whole equation. As most drugs consumed in the country are imported, it behoves the service to be more dispassionate in their service delivery. Thus they face the problems of drug importation through both the sea and land borders. The customs authorities posit that a major problem they confront on a daily basis is that of imported drug declaration. In the midst of this is the issue of imported substandard medicines and other forms of health products.
It is indeed a herculean task – checking the spate of substandard and fake drugs that come into Nigeria through these faceless merchants of death. And as the authorities declare an onslaught on the illegal practice, so we have the unintended reactions from their activities: drug availability is inadvertently affected in the negative because invariably as the ‘cancerous’ elements are being destroyed even the good ones also suffer in the clampdown.
In effect therefore, it becomes more crucial than ever before that the Nigerian Customs service in the cause of their duty collaborate very effectively with the National Agency for Food and Drug Administration and Control (NAFDAC) in ensuring efficiency and complete sanity in the entire system.
Meanwhile on his part, Mr. Francis Alaneme – a representative from the federal Ministry of Trade has heavily berated the laisser-faire attitude of the healthcare professionals and importers, as well all other professional stakeholders towards the provisions already made by government. According to Alaneme, the government has made available lots of incentives that will make for ease of doing business, but the concerned stakeholders have failed to take advantage of these opportunities.
He states that apart from the extant laws and regulations, the government has in addition made available intervention funds that anyone can access for the benefits of doing seamless business transactions in Nigeria. Yet some stakeholders argue that even when these laws are there, the problem is still that of enforcement. And now the question remains: who will bell the cat?

 

Morgan Nwanguma

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