1 1.0 Introduction The Pharmaceutical Act 20041 was assented to on 2nd September, 2004.

It repealed the Pharmacy and Poisons Act 1940 and the Therapeutic Substances Act 1968. It provides for the registration and regulation of medicines intended for human consumption and also for veterinary use. It also provides for the regulation, and control of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, sale and use of medicines, herbal medicines and allied products.

The objective of Pharmaceutical laws is to protect the general public from counterfeit, bogus or adulterated drugs. For example, a person who has malaria must receive medicines that have been designed, tested and found effective for malaria. History is replete with examples of questionable concoctions that were offered to treat certain ailments. However, time and new discoveries have shown that these were completely useless concoctions.2

The necessity to enact a new law arises to meet new challenges posed by advancement of society. Science continues to discover new medicines and drugs that were not subject of the old Acts. It means that the old tools for control of these drugs or medicines may no longer be effective to control the newly discovered drugs after the old Act. For example, a compound called Arsenic was not on the poisons list of the Pharmacy Act of 1868 of Great Britain. How, the Pharmacy Act 1908 recognized Arsenic as a poison and was therefore a

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Act No. 14 of 2004. Patricia Barton, Quality of Quinine preparations in Indian Hospitals and Dispensaries. Indian Medical Journal Volume 74, October 1939, as reported in the Article, The Great Quinine Fraud, Social History of Alcohol and Drugs, University of Strathclyde, Glasgow. Volume 22 No. 1, 2007 at 6.

2 subject of control.3 The quest for new and effective legislation that will adequately deal with emerging problems is therefore of cardinal importance.

2.0 Statement of the Problem The Pharmaceutical Act 2004 also establishes the Pharmaceutical Regulatory Authority, which replaces the Pharmacy and Poisons Board that was obtaining under the old Pharmacy and Poisons Act4. It is the main body that enforces the provisions of the Act. The Act stipulates the functions and powers of the Pharmaceutical Regulatory Authority.5 The Pharmaceutical Act 2004 repeals and replaces The Pharmacy and Poisons Act6 and The Therapeutic Substances Act7 both of which governed the pharmaceutical sector. While the Pharmaceutical Act 2004 is a progressive piece of legislation, there are still challenges as far as enforcement of provisions of the Act is concerned. An evaluation of the provisions of the Act will bring up some of these challenges. To demonstrate, the Act prohibits operating of a pharmacy without registration.8 However, no one will setup a pharmacy in a remote place like Mpulungu, for the simple reason that it is not commercially viable because a full-fledged pharmacy requires huge investment. Setting up small shops would clearly be illegal although it is clear the inhabitants need medicines and they are forced to resort to illegal vendors. Regulators are therefore in a moral dilemma, either to apply the letter of the Law or turn a blind eye. Secondly, while the Law itself maybe adequate, organisational problems like inadequate staff may hamper application of the Law. Thirdly,

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Schedule A, Part 1 Chapter 299 of The Laws of Zambia 5 Pharmaceutical Act No. 14 of 2004, ss.5 and 6 6 Chapter 299 of The Laws of Zambia 7 Chapter 310 of The Laws of Zambia 8 Pharmaceutical Act, s14

3 powerful commercial interests invariably influence application of the Law by influencing Law enforcement agents to take a cursory approach to apply the law in their favour.

3.0 Research Objectives The purpose of this study is to explore these challenges created by advancement in the Pharmaceutical field and examine the new Pharmaceutical Act, 2004. It will look at how the Act attempts to meet these challenges and in particular the provisions for control of medicines and how they are supposed to protect members of society. It looks at the enforcement mechanisms designed to ensure compliance and assesses their effectiveness. It also enquires on particular problems and challenges faced by the body charged to administer the Act, that is the Pharmaceutical Regulatory Authority.

4.0. Significance of the study The pharmaceutical field is a unique field. It has problems and processes that are peculiar to this field only. It is important that some of these problems be evaluated in their own context.

5.0 Literature Review The Pharmaceutical Act No. 14 of 2004 governs the supply and possession of medicines in Zambia. It sets out what medicines maybe manufactured or imported into this country, who should import or manufacture these medicines, How, or the procedures to be followed and the attendant consequences if these provisions are flouted. It also governs where these

4 medicines and the conditions under which these medicines must be stored and supplied. These are contained in the main Act itself and/ or in subsidiary legislation.

While it is desired that the Act covers all conceivable situations, it is nevertheless impossible to do so. For example, the main Act makes provision for control of Herbal medicines. However, no regulations have been made pursuant to the Act to administer the exercise.9 This may result in the Law being applied in the wrong way leading to challenges of administrative procedures by way of Judicial review.

Molan in his Administrative Law10 book discusses administrative procedures and the attendant remedy of judicial review. Munalula in her article on the Legal Framework Governing Sovereign Debt in Zambia highlights the effects of the gap between Law and Society. This helps in understanding the effectiveness of Laws when the gap between Law and Society is either wide or narrow.11 Kulusika in his article in the same volume discusses Law as an Instrument of Change12 and discusses in what circumstances Law can be successfully used as an instrument of change.

6.0 Specific Research Questions Given the nature of the research and the fact that it is very current and as we have seen from the foregoing, and the fact that medicines are very important in the wellbeing of
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Pharmaceutical Act No. 14 of 2004, s47 M. Molan, Administrative Law. Old Bailey Press 2003 11 M.M. Munalula, A Critique of the Legal Framework Governing Sovereign Debt in Zambia, Zambia Law Journal Volume 33 of 2001 at 63 12 S.E. Kulusika, Penetential Redemption: Law as an Instrument of Change, Zambia Law Journal Vol. 33 of 2001 at 83
10

5 society, it is poised to affect a large segment of Zambian society in the way they access medicines. There a number of legal research questions which can be asked but not limited to the following questions:1. Rationale and History of the Pharmaceutical Act. 2. Why has it been necessary to enact a new Law? 3. Who does it serve or protect and how does it do this? 4. What are the mechanisms available under the Act for enforcing the provisions of the Act? Are they adequate? What sort of sanctions are available? 5. How different is this Act from previous Acts? What gaps has it filled? 6. What is the impact of this new Act? 7. As with all positives, negatives are bound to emerge. What are the problems raised by the new law? What are the possible remedies? 8. What are probable effects of the Pharmaceutical Act to other existing laws including Constitutional compliance?

7.0 Research Methodology The study will be a desktop study as well as a field study. It will review relevant literature of the subject matter in issue, interviews with key stakeholders such as the Pharmaceutical Regulatory Authority, The Pharmaceutical Society of Zambia, Drug manufacturers, Drug importers, Pharmacy proprietors, medical and Hospital establishments, a section of society as consumers of medicines, relevant Government ministries and related statutory creations such as Ministry of Commerce, Trade and Industry, Zambia Development Agency, the

6 Zambia Police Service, the Anti Corruption Commission, Zambia Revenue Authority Customs Division and the Drug Enforcement Commission.

8.0 Organization of the Study The study will be organized as follows:1) Chapter One; will be the introduction and rationale behind the Pharmacy Act. 2) Chapter Two; will examine the history of pharmaceutical regulation in Zambia, analyzing the gaps in the legislation as the arose and how these gaps have been filled. 3) Chapter Three; will analyze the provisions of Act. 4) Chapter Four; will look at the implementation and enforcement mechanisms available under the Act. 5) Chapter Five; will analyze the probable failures and successes of the Act 6) Chapter Six: General Conclusion

9.0 Proposed Research Plan Date Week 2 of October 2009 Week 2 of November Week 4 of December Activity Submission of the Proposal Submission of introduction and Chapter One to Supervisor Submission of Chapter 2

7 Week 2 of January 2010 Week 4 of January Week 2 of February Week 4 of February Week 2 of March Week 1 of April Submission of Chapter 3 Submission of Chapters 3 & 4 to the Supervisor Submission of Chapters 5 & 6 to Supervisor for corrections Completion of the first complete draft Submission of first complete draft to the Supervisor Submission of final document to Coordinator in duplicate

REFERENCES

A. Publications: 1) Munalula, M. Legal Process: Zambian cases and commentaries. University of Zambia, 2004. 2) Molan, M. Administrative Law. Old Bailey Press 2003. 3) Munalula, M.M., A Critique of the Legal Framework Governing Sovereign Debt in Zambia. Zambia Law Journal Volume 33, 2001

8 4) Kulusika, S.E., Penitential Redemption: Law as an Instrument of Change. Zambia Law Journal Volume 33, 2001 5) Sifuna, N. and Mogere, S., Enforcing Public Health Law in Africa: Challenges and Opportunities, the Case of Kenya. Zambia Law Journal Volume 34, 2002 6) Barton, Patricia, Quality of Quinine preparations in Indian Hospitals and Dispensaries. Indian Medical Journal Volume 74, October 1939, quoted in the article, The Great Quinine Fraud. Social History of Alcohol and Drugs. Volume 22 No.1 University of Strathclyde. Glasgow.

B. Legislation 7) The Pharmaceutical Act No. 14 of 2004 8) The Pharmacy and Poisons Act Chapter 299 (Repealed) 9) The Therapeutic Substances Act 1968 Chapter 310 (Repealed) 10) The Poisons and Pharmacy Act 1908 of Great Britain