Consequences of Removing Drugs and Poisons from the Exclusive Legislative List
March 9, 2018,
The attention of the Agency has been drawn to a publication by the Pharmaceutical Society of Nigeria (PSN) in the Daily Trust Newspaper of 17th February 2018 on the recommendation by the reform panel of the ruling party led by Governor Nasir El-Rufai that proposes to move drug matters which are presently on the Exclusive List (item 21 of part I of the second schedule of the 1999 constitution) to the concurrent list. NAFDAC as an Agency of Government and a major stakeholder in drug regulation in the country, thought it important to lend its voice to this emerging concern as such recommendation portends great danger for the nation.
The nation has over the years put in place several policies and measures to ensure drug security and improved healthcare delivery in the country. Some of these measures include a national Drug policy which is targeted amongst other objectives to make available at all times to the Nigerian populace adequate supplies of drugs that are effective, affordable, safe and of good quality.
The country is also putting a lot of effort to strengthen administrative, legislative, and regulatory controls of the importation, exportation, manufacture, procurement, storage, distribution, supply, advertisement, sale and use of drugs in tandem with global best practice as obtained all over the world.
The reasons for placing drugs and poisons on the exclusive legislative list by countries are not far-fetched. These include but not limited to the following:
- Firm control on drugs and drug-related matters by the federal government.
- Prescription and enforcement of grades and minimum standards of quality for drugs and drug products.
- Prevention of drug misuse and abuse by central regulatory control on substances of abuse.
- Protection of patent rights for innovators of medicines to prevent infringement and promote data exclusivity.
- Entrenchment of a rational and properly structured drug distribution system
- Enhancement of compliance with Trade-Related aspects of Intellectual Property Rights (TRIPS) agreement
- Strengthening of regulatory mechanisms in line with globalization and medicines regulatory harmonization.
No nation ever compromises the well-being of its citizens by way of liberalizing and decentralizing medicine legislation.
A thorough analysis of global best practices showed that where regulatory controls are placed on the exclusive legislative list, the prevalence of counterfeiting and other drug-related vices are at the lowest ebb.
The burden of counterfeit drugs is a global phenomenon that has plagued even the most technologically endowed nations. On account of the enormity of this public health menace, regulation and control of medicines as well as related activities in all countries are centrally coordinated to enhance effective and adequate governmental control and assert adequate regulatory oversight on account of retaining control of medicines in the exclusive list.
Removal of drugs and poisons from the exclusive legislative list will lead to multiplicity of drug legislations having innumerable dire consequences that include the following:
- Lack of uniformity of standards of drug products across the country
- Chaotic drug legislation that will discourage foreign investment and disruption of existing collaboration with international support partners and donor agencies.
- Defeat of the purpose of the Federal Government’s drive on ease of doing business in the country as different jurisdictions will have different requirements.
- Proliferation of organized crime and money laundering offences.
- Loss of recognition of the country as a preferred destination for clinical research due to haphazard legislative requirements.
- Lowered product quality standards will further worsen Nigeria’s health indices
- Aggravation of the current menace of misuse and abuse of controlled drugs
- Infringement on patent and intellectual property rights which will have untoward consequences on the nation being a signatory to the Trade-Related aspects of Intellectual Property Rights (TRIPS) agreement.
- Proliferation of Counterfeiting, falsification of medicines, spuriously labeled pharmaceuticals and allied products, pronounced adverse drug reactions, entropic Pharmacovigilance reporting system, unwholesome and sharp practices to mention a few.
Issues ranging from poorly packaged medicines, expansion of open drug markets, sharp practices centered on pecuniary interest, compromise in the drug registration process and unprofessional licensing procedures will be the outcome of movement of drugs and poisons from the exclusive to the concurrent legislative list.
Our dear country cannot afford to go that route. Rather, the various drug regulatory agencies and bodies should be strengthened and given more support through the federal might. NAFDAC for instance has over the years been at the forefront of seeking more punitive measures for drug offenders and counterfeiters through the legislative arm of government but this bill is yet to see the light of day. Governmental support to stimulate more collaboration with international agencies to fight the civic threat called fake drugs can only make meaning where drug and pharmacy related issues are retained on the exclusive list.