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Medicine Safety: The Zambian Historical Perspective – Part V

[By Brian Muwanei Kabika]

1. Introduction

In this article, we shall continue to discuss where we left in Part IV, discussing the Pharmaceutical Act No. 14 of 2004 of the Laws of Zambia, which established the Pharmaceutical Regulatory Authority (PRA). Today`s discussion will also mark the end of the series on “Medicine Safety: The Zambian Historical Perspective.”

(viii) The Pharmaceuticals Act No. 14 of 2004
Below are some of the noticeable features that were in the Pharmaceutical Act:
a. Traditional medicines were not regulated by the Act.

b. Substandard medicines in circulation could be recalled, destroyed and offender(s) prosecuted by the Pharmaceutical Regulatory Authority.

c. Establishment of a medicines committee to monitor standards of medicines being manufactured, marketed and circulated in Zambia.

d. Facilities engaged in the manufacturing of medicines were required to be registered.

e. Manufacturing and distribution of medicines without a manufacturing licence was prohibited and failure to possess a licence for the same was prosecutable.

f. Retailers of medicines and those buying bulk medicines for resale were protected against buying substandard medicines by ensuring that wholesale dealers were registered to trade in bulk medicines.

g. Introduction of prohibition on the manufacturing, importing, distribution and selling of substandard or counterfeited medicines.

h. Manufacturing, importing, distribution and selling of substandard or counterfeited medicines attracted a punishment of a fine amounting to not more than K150,000 or imprisonment of not less than five years or both.

i. Establishment of the National Drug Quality Control Laboratory to test the standard of medicines, verify the safety of manufactured and distributed medicines.

(ix) The Animal Health Act No.27 of 2010
The Animal Health Act No.27 of 2010 become operational on 26th August 2010. It regulates the prevention and control of animal diseases, the importation and exportation of animals, animal by-products, articles and animal feed, among other things. Under the Act, importation, exportation, manufacture and sale of vaccines and serum is not permitted unless authorised on a permit by the Director of veterinary services.

(x) The Medicines and Allied Substances No. 3 of 2013

Nine years after the Pharmaceutical Act No.14 of 2004 was enacted, the government decided to repeal it on 23rd March, 2013 through the Medicines and Allied Substances Act No. 3 of 2013 of the Laws of Zambia. The Act retained the PRA and renamed it as Zambia Medicines Regulatory Authority (ZAMRA).

The Act was repealed under the government programme that was undertaken to reduce the cost of doing business because of multiple licensing systems by regulatory agencies. This process saw reviews of several Acts and enactment of the Business Regulatory Act (No. 3) of 2014 of the Laws of Zambia, which established the Business Regulatory Review Agency. The Pharmaceutical Act was one of those laws that was identified to have multiple licences, hence, the need to reduce them. Small traders intending to invest in the pharmaceutical sector had challenges to satisfy the requirements of trading in medicines and other pharmaceutical products.
The important points to note about the Act (still enforce) are:
a. The term “distribute” is defined in the Act as the division and movement of pharmaceutical products from the premises of the manufacturer of the products or from another central point to an intermediate point or to the end user by means of any method of transport.
b. The meaning of the term “medicine” is modified. It now means human medicine, veterinary medicines, medicinal products, herbal medicine or any other substance or mixture of substances for human or veterinary use intended to be used or manufactured for use for its therapeutic efficacy or for its pharmacological purpose in the diagnosis, treatment, alleviation, modification or prevention of disease or abnormal physical or mental state or the symptoms of disease in a person or animal.”

The Act distinguished different types of clusters of medicines; that is, human medicines, veterinary medicines, herbal medicines, medicinal product, other substances or mixture of substances. The term “substandard medicine” is finally defined in the law. It means “a product whose composition and ingredients do not meet the approved quality specifications and which may be consequently ineffective and often dangerous to the patient.”

Substandard medicines in the Act is somewhat very similar to the WHO definition except that the words “often dangerous to the patient” are not included in the definition of the WHO.
c. Establishment of Expert Advisory Committee to the Board on the safety of medicines. This Committee’s purpose was equivalent to the Medicines Committee under the Pharmaceutical Act.

(xi) The Customs and Excise Act Chapter 322
Apart from the Medicines and Allied Substances Act No.3 of 2013, there are other laws that are used to regulate medicines and allied substances. One of them is the Customs and Excise Act, Chapter 322 of the Laws of Zambia.

The Customs and Excise Act Chapter 322 is enforced by the Zambia Revenue Authority (ZRA). The ZRA has the mandate to collect tax on goods manufactured within and imported into Zambia. It has also the authority to inspect goods including medicines that pass through the borders dotted around the country. The Minister under the Act has the power to restrict through which ports goods may come in Zambia. It is through such restrictions that the importation of pharmaceutical products such as medicines and allied substances are regulated, thereby protecting the public from consuming substandard products. The Act also empowers ZRA with enormous powers that include and not limited to: seize goods, inspect documents, inspect premises, inspect vehicles and any receptacle, warehouse, building or ant premises, taking samples and others.

(xii) The Narcotic Drugs and Psychotropic Substances Act No.35 of 2021
The Narcotic Drugs and Psychotropic Substances Act, No.35 of 2021 (Act) of the Laws of Zambia, repealed and replaced the Narcotic Drugs and Psychotropic Substances Act Chapter 96 and continued the functions of the Drug Enforcement Commission (DEC), which is established as an investigative commission under Clause (b) of Article 235 of the Constitution of Zambia of 2016. The Act prohibits the use of narcotic drugs and psychotropic substances without authority (illicit activities) whereas the Dangerous Drugs Act, Chapter 95 regulates the illicit use of narcotic drugs and psychotropic substances, having found with controlled medicines without authority. The Act has expanded the mandate of DEC compared to Chapter 96. The long title of the Act reads:

“An Act to provide for the functions of the Drug Enforcement Commission; revise and consolidate the law relating to drugs and precursor chemicals; provide for special measures relating to the prevention, treatment and rehabilitation of victims of drug abuse; domesticate the Convention on Psychotropic Substances 1971, the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 and the United Nations Convention against Transnational Organised Crime, 2003 repeal and replace the Narcotic Drugs and Psychotropic Substances Act, 1993, and provide for matters connected with, or incidental to, the foregoing.”

Further, the Act has defined conventions, narcotic drug, precursor chemical and psychotropic substances. In Chapter 96, these terminologies were either inadequately defined or not defined at all.

“Conventions” means the—
(a) Convention on Psychotropic Substances which entered into force on 16th August, 1976, and was acceded to by Zambia on 28th May, 1993;
(b) United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances which entered into force on 11th November, 1990, and was ratified by Zambia on 28th May, 1993; and
(c) United Nations Convention against Transnational Organised Crime which entered into force on 29th September, 2003, and was acceded to by Zambia on 24th April, 2005;
“narcotic drug” means a natural or synthetic substance set out in the Second Schedule to this Act; “precursor chemical” means a substance that is requisite in the manufacture of a narcotic drug or psychotropic substance as set out in the Fifth Schedule to this Act; and
“psychotropic substance” means a natural or synthetic substance set out in the Third Schedule to this Act.

Section 4 (1) of the Act provides for the functions of DEC and these include:
(a) Prevent, investigate and control the supply and demand of a drug and precursor chemicals;
(e) Co-operate with other institutions in investigating, prosecuting, preventing and combating drug trafficking and prohibited activities relating to drugs or precursor chemicals so as to implement an integrated approach to the eradication of drug trafficking and prohibited activities relating to drugs or precursor chemicals;
(f) Consult, co-operate and exchange information with appropriate bodies regionally or internationally that are authorised to conduct inquiries or investigate cases of drug trafficking and other transnational crimes.

DEC officers have been empowered under this Act to, seize, arrests and prosecute violators of the Act.

(xiii) The Competition and Consumer Protection Act No.24 of 2014
The Competition and Consumer Protection Act (No.24) of 2014 established the Competition and Consumer Protection Commission (CCPC). The Act has a provision that prohibits the supply of defective and unsuitable goods. Goods in this Act appears to include medicines. The CCPC and its officers have powers to investigate any complaint arising from the Act or may refer a complaint to a relevant body if it finds that the complaint falls under another institution.
(xiv) The Penal Code Chapter 87

The Penal Code was enacted in 1930 (Code) and is one of the oldest pieces of law in Zambia. This Act is usually enforced by the Zambia Police Service. Zambia Police Service is established under the Constitution of Zambia of 2016. The Code through sections 186 and 187 regulates medicines and allied substances. Sections 186 and 187 of the provides:
“186. Any person who adulterates any drug or medical preparation in such as manner as to lessen the efficacy or change the operation of such drug or medical preparation, or to make it noxious, intending that it shall be sold or used for, or knowing it to be likely that it will be sold or used for, any medicinal purpose, as it had not undergone such adulteration is guilty of a misdemeanour.”

“187. Any person who, knowing any drug or medical preparation to have been adulterated in such as manner as to lessen its efficacy or to change its operation, or to render it noxious, sell the same, or offers or exposes it for sale, or issues it from any dispensary for medicinal purposes as adulterated, or causes it to be used for medicinal purposes by any person not knowing of the adulteration, is guilty of a misdemeanour.”

2. Conclusion

In concluding the series on “Medicine Safety: The Zambian Historical Perspective,” it can be argued that medicine regulation has been chronicled from the historical perspective in Zambia, from pre to post-independence. The information shared in these series, from Part I to V have been helpful, in showing the policies and historical development of these policies towards the regulation of medicines in Zambia. It is hoped that the information has been helpful to the readers who requested for this topic to be addressed.

For any comments, please email: muwanei.kabika@gmail.com

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