Enforcing public health law zambia law journal volume patrick barton

NATIONAL INSTITUTE OF PUBLIC

BY: NATASHA MUSENGA JUNE 2018.

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Natasha Musenga

Computer Number 26051681

SUPERVISOR

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DEDICATION

ACKNOWLEDGEMENTS

Firstly I would like to thank the Lord almighty for his blessings throughout my research work to complete the study with such success. He has been faithful and I chose to believe in him and wait for the glory he has prepared for my life.

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Finally I would like to extend my thanks to the National Institute of Public Administration (NIPA) staff and students, for their support during my study. “NIPA MADE ME”

CASES

Pharmaceutical Society of Great Britain v White [1901] 1 QB 601

The people v Lusaka Medi Camp and Others (2008)

The People v Reomer (1915) 168

Northern Rhodesia Proclamation No.21 of 1921 which later became the Poisons Ordinance Chapter 98 of 1930

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The Medicines and Allied Substances Act No. 3 of 2013

International statutes

Medicines Act of 1968

Northern Rhodesia Proclamation No.21 of 1921

ABSTRACT

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It remains the essayist’s optimism that this research makes a substantial contribution to the present-day of pharmaceutical regulation.

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TABLE OF CONTENT

CHAPTER 1

1. Rationale of Pharmaceutical Legislation…………………………………….

   5. Research Question/Hypothesis

   6. Scope of Study

2. Historical Background of Pharmaceutical Legislation and Regulation

   1. Regulation in the United States

2.3 Regulation in Zambia

2.4 Conclusion

3. 1. 2. Consumer Protection

      3. Prohibitions
   2. 3. Details of Inspections/Observation

   3. Conclusion

1. Implementation Problems

2. Conclusion

5. 3. General Conclusion

   4. Recommendation

REPORTS

RESEARCH PAPERS

Health systems cannot function without pharmaceuticals. By complementing other types of health‐care services, pharmaceuticals can reduce morbidity and mortality rates and enhance quality of life. Access to health care and essential medicines is therefore increasingly viewed as a fundamental human right. It is also important that pharmaceuticals are accessible, of proven quality and safety and that they are properly used to save lives, reduce suffering and improve health.

Many countries are unable to achieve such standards. It is estimated that today, one third of the world’s population does not have regular access to essential medicines. In some of the lowest‐income countries in Africa and Asia, more than half of the population has no properly functioning medicine authorities to regulate the medicines market, including registration of medicines, inspection of pharmaceutical establishments and control of drug promotion. Unreliable supply systems persist, and irrational use of medicines is a major problem worldwide (WHO, September 2007).

1.3 SIGNIFICANCE OF STUDY

The study seeks to provide scholarly insight on the consequences of the proliferation of pharmaceuticals in Lusaka. It will be of value to the Law makers in understanding the issues on the ground and help alleviate the problems that come with this proliferation. This is against the background that the problem of having littered pharmacies with unqualified staff making it easy for the public to access medicines over the counter that may not be properly prescribed and detrimental to their health.

This interrogation of all the stakeholders of this critical sector using the derived questions, arising out of the objectives, will assist the researcher to draw conclusive assertions, providing the most valuable aspect of a researcher undertaking, establishing, overall, to what extent all stakeholders are compliant to the existing legislative regime, espousing also to what extent legislative amendments can prevail in order to constantly align with compliance requirements in the establishment and dispensation of the pharmaceutical services being examined.

Importantly a legislative regime is not left only at enactment stage, but goes so far as to the required follow on actions, which if followed to the letter, assures of a consistent application of the enacted legislation, in as far as compliance is concerned.

How can enacted legislation be effectively implemented to effect compliance in the establishment and dispensation of pharmaceutical services? And to what is the extent of non-compliance compliance in the establishment and dispensation of pharmaceutical services?

What accounts for non- compliance, if any, in the establishment and dispensation of pharmaceutical services? How can the factors contributing to the non- compliance in the establishment and discharge of pharmaceutical services be effectively eliminated?

Medicines available before the 19^th century varied from harmless flavored waters to dangerous poisons. Yet until the mid-1800s their supply was unregulated. In the late 1840s public concern emerged about the unrestricted availability of poisons. Large numbers of deaths resulting from poisoning were reported. Many solutions to the problem were proposed, including a total ban on its retail sale. These formed the basis of the Arsenic Act 1851. For the first time retail sales of poisons were to be restricted. In the late 1850s more high profile poisoning cases raised calls for greater control over poisons. In May 1868, a bill produced by the Pharmaceutical Society was introduced in the House of Lords. An attempt to limit the supply of powerful drugs, especially narcotics, to prescription only was defeated because of powerful interests in the House of Lords who did not want to see narcotics controlled. The position of the pharmaceutical Society was that the most effective safeguard in the supply of poisons to the public was to restrict their sale to pharmaceutical chemists, who would be able to exercise their professional judgment¹.

This research will use a mixed method design, involving both qualitative and quantitative designs. As such, open and closed ended questions will be used through a questionnaire and interview guide to the various respondents and key informants respectively. This will lead to collection of beneficial information regarding this topic. Interviews with key stake holders will be done with institutions such as the Pharmaceutical Society of Zambia, Zambia Medicine Regulatory Authority, Zambia Beaurea of Standards, pharmacy proprietors and a section of society as consumers

1.10 CONCLUSION

Drug regulatory agencies play a key role in ensuring that medicines available for use are safe and effective. We will see in this chapter the events in history that necessitated the introduction of drug regulatory systems. The review of history will make us understand what created the need for legislation in the field.

At the start of the nineteenth century, new legislations for medicine control started coming into effect due to multiple tragedies worldwide. The quality of drugs and food was virtually unregulated. This was the era when ancient traditions of manufacturing and distribution of drugs evolved into the modern highly organized pharmaceutical industry and controlled system of Drug Regulatory Affairs (DRA). This was created in an attempt to improve conditions and safeguard the health and welfare of people.

The development in the vaccine was necessitated by the vaccine tragedy which happened in the United States in 1901, this was after 22 children who had contracted tetanus had died from contaminated vaccines. In response to the tragedy The Biologics Control Act of 1902 came into force shifting vaccine manufacturing from health authority to Vaccine Industry. Due to issue of safety and efficacy, pre-marketing approval with scientific safety data becomes mandatory². These regulations were further defined by classifying drugs into Over-The-Counter (OTC) and Prescription Only category. The USFDA has grown from one chemist to more than 9000 employees currently. In summary, US Health Authority has grown from one chemist to more than 9000 employees, no scientific data to pre marketing approval with scientific data, drug categorization and various regulations for new drugs, biologics as well as marketing authorization. Therefore this law paved the way for further regulation of drug products³.

The abuse and misuse of drugs formed the basis of the Arsenic Act of 1851. For the first time retail sales of poisons were to be restricted⁴.

2.2.1 THE EXPANSION OF CONTROL

With the enactment of the Pharmacy and Poisons Act of 1868 the Pharmaceutical Society was granted powers to deem a substance a poison, to decide which substance should be available for sale, and who should be allowed to become both authorize and listed sellers of poisons. The Pharmacy Act further gave pharmacists responsibilities in the control of poisons. The purchaser of opiates had to be known to the seller, and that an entry is made in the Poisons Register.

The Medicines Act of 1968 consolidated the legislation concerning the regulation of medicines. However, it did not include herbal medicines and foods with vague medicinal claims⁵.

Comprehensive treatment of Pharmaceutical legislation in Northern Rhodesia now know as Zambia, took place by way of enactment of a new statute in 1940. This was the Pharmacy and Poison Ordinance No. 38 of 1940. It repealed and replaced the Poison Ordinance of 1921. This statute was practically handed down from the colonial masters, who had the benefit of experience of filling gaps in the legislation of the motherland⁶. This statute widened the scope of pharmaceutical regulation and introduced several safeguard.

Further safeguards were the requirement that all medicines should meet certain standards, in this case standards set by the British Pharmacopoea and the British Pharmaceutical Codex, which are professional reference books⁷.

Further changes over the years occurred by way of subsidiary legislation. There were periodic additions to the poisons list created⁸. For example, in 1815, Nalidixic Acid, a new compound, was added to the poisons list⁹. Later, it was discovered that there were substances that were not strictly poisons and hence did not fall under the control of the Pharmacy and Poisons Act, but were therapeutic in nature. Misuse of these substances could lead to undesirable effects. Therefore, the Therapeutic Substances Act of 1968¹⁰ was enacted to control these substances.

In the Pharmaceutical Act No.14 of 2004 which is the current applicable Act. The objective of the Pharmaceutical Act is to protect the general public from counterfeit, bogus or adulterated, and unsafe drugs¹¹. It consolidates the laws and regulations that were already in existence such as the; Pharmacy and Poisons Act of 1940, the Food and Drugs Act and the Therapeutic Substances Act. Further, the Act over the years has plugged in some gaps that were discovered over the years. An example of such a gap is that the Act establishes the Pharmaceutical Regulatory Authority (PRA) which is responsible for registration and regulation of pharmacies; registration and regulation of medicines, herbal medicines and allied substances intended for human use and for animal use; regulation and control of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, sale and use of medicines, herbal medicines and allied substances. The key functions to achieve this include the registration of medicinal products, inspections of facilities and products, licensing of pharmaceutical premises (retail, wholesalers, and manufacturing sites) and issuing of import and export licenses and permits. However, the Act does not regulate the practice of pharmacy professionals. Pharmaceutical staffs are registered under another piece of legislation¹².

Another piece of legislation that has helped in the regulation of the pharmaceutical industry is The Pharmacy and poisons Act. In its preamble its states that it is “An Act to make better provision for the control of the profession of pharmacy and trade in drugs and poison.” It regulates the registration of pharmacists, and also where such business is permitted to be carried out and it contains the poison list that is drafted by the Board and approved by the Minister of Health.

Many countries are unable to achieve high standards of regulation. It is estimated that today, one third of the world’s population does not have regular access to essential medicines. In some of the lowest‐income countries in Africa and Asia, more than half of the population has no properly functioning medicine authorities to regulate the medicines market, including registration of medicines, inspection of pharmaceutical establishments and control of drug promotion. Unreliable supply systems persist, and irrational use of medicines is a major problem worldwide¹³.

CHAPTER THREE

This chapter will therefore discuss the importance of the Pharmaceutical Act. It will look at its role in the registration and regulation of pharmacies. Further it will discuss how a retail business of a pharmaceutical business is to be established and what are the requirements needed with regards to the law in line with the established guidelines given by the Pharmaceutical Regulatory Authority.

3.1 SALIENT PROVISONS OF THE PHARMACEUTICAL ACT

Part II has eight sections. This part is about the Pharmaceutical Regulatory Authority, the body established under the Act to administer the Act. It sets out its powers, functions, what constitutes the board and other organs of the board.

Part III of the Act makes provisions for management of pharmacies. No person other than a registered pharmacist can carry on, either on their behalf or on behalf of another person the business of a pharmacist. In Pharmaceutical Society of Great Britain v White¹⁴, it was held that the purpose of pharmaceutical laws was to ensure protection of consumers. It was further held that every chemist must have a registered pharmacist to supervise the sale of poisons, otherwise, a registered pharmacist may own or run a string of pharmacies and yet not be able to supervise all of them adequately, thus exposing consumers to the danger of being sold wrong medicines.

In consultation with the Society (The Pharmaceutical Society of Zambia) and on the recommendation of the Authority, the Minister of Health may, by regulation determine standards for the practice of pharmacy in pharmacies and hospital pharmacies.

Part VII is a new area. It makes provisions for clinical trials in humans and also the testing of medicines on animals. It introduces licensing requirements for clinical trials and animals and prescribes conditions that must be met for a license to be granted.

No person is allowed to operate a pharmacy except under the authority of a pharmacy registration certificate issued under section 13¹⁵.

3.1.4 EXEMPTIONS

3.2 SALIENT PROVISONS OF THE ZAMBIA MEDICINES REGULATORY AUTHORITY GUIDELINES FOR ESTABLISHMENT OF A PHARMACEUTICAL RETAIL BUSINESS

3.2.1 PARTICULARS OF THE PREMISES

(i) The following certificates should be available:

Certificate of Incorporation issued by Patents and Companies Registration Agency (PACRA), Certificate of registration (if pharmacist is one of the directors and will be the pharmacist in charge), Certificate of Payment: Business Levy issued by the local authority, and lastly Fire Safety Certificate issued by the local authority

The artificial and natural ventilation should be satisfactory i.e. the air conditioner should be well functioning and adequate windows and air vents should be available. The natural and artificial lighting should be satisfactory e.g. availability of adequate windows i.e. electric/solar light. The floor should be smooth and easily washable, the walls should be clean with coat of paint and the state of the roof/ceiling should be intact and not leaking and must have enough ventilation.

The following storage facilities should be available:

Self-adhesive labels, self-sealing plastic packs and any other.

(iii) The following facilities for safe storage and distribution of Controlled or Narcotics drugs and Psychotropic substances drugs should be available: Dangerous drugs register and lockable cupboard.

(i) The following reference materials should be available:-

Zambia National Formulary (ZNF) - recent edition is preferred, British National Formulary (BNF) - recent edition is preferred

Looking at the above discussion, it is seen that there are legal provisions that help the regulation of the pharmacies business. Both the Pharmaceutical Act of 2004 and the Pharmaceutical Regulatory Authority have rules and regulations that need to be followed for a retail pharmaceutical business to be operational. This is because if left unchecked there will be selling/ distribution of drugs haphazardly and the creation of pharmaceutical business retails carelessly. But the real question is how enforceable are the laws and requirements that are laid down above? How are they been implemented and has this curbed the mushrooming of unregistered pharmacies and selling/ distribution of drugs without proper prescriptions from a qualified medical practitioner?

CHAPTER 4

Inspectors are appointed by the Pharmaceutical Regulatory Authority to carry out the enforcement procedures¹⁶. These inspectors have varies duties which include monitoring and inspecting and where anyone is found wanting, the enforcement of the provisions of the Act will be invoked. They have power in terms of the law to enter the premises of a person carrying on the business of a manufacturer, seller or distributor of any substance that is the subject of the Act and to demand the production of and inspect any books relating to the manufacture, sale or distribution of such medicines and to inspect any stock of any such substance¹⁷.

The case of The People v Kaluba Kampamba¹⁸ is an example. Kaluba was arrested in Ndola. He was accused of running an illegal pharmacy in contravention of Section 14(1) and 14(2) of the Pharmaceutical Act of 2004. He pleaded guilty and was fined Nine Million Kwacha (k 9000, 00) or in default, imprisonment of seven months.

4.2 IMPLEMENTATION PROBLEMS

Zambia Medicines Regulatory Authority had arrested two people in Chawama and John Laing Townships for allegedly operating an illegal drug store and selling Government labeled drugs. The two ladies who were arrested told the Zambia Medicines Regulatory Authority that they not the owners, so Zambia Medicines Regulatory Authority carried out investigations to ascertain who the owners of the drug stores were. There was no conclusive evidence to establish who the owners were and therefore the prosecuted the two ladies¹⁹. This means that these two women were not qualified pharmacist’s and therefore had no training or any capacity to carry on a pharmaceutical retail business.

Due to levels of corruption persons of the public pose as inspectors of the Zambia Medicines Regulatory Authority or even Drug Enforcement Commission. This is done so as to solicit money from drug store owners. This has been the case where Zambia Medicines Regulatory Authority had arrest a 27 year old man of Lusaka for allegedly impersonating as a Zambia Medicines Regulatory Authority Inspector. Mr. Roy Kabwe was arrested for allegedly masquerading as an inspector and soliciting money from drug store owners. The Zambia Medicines Regulatory Authority had received complaints from members of the public about Mr. Kabwe who was allegedly soliciting money promising people that he will give them a trading licence. Zambia Medicines Regulatory Authority Public Relations officer Mr. Ludovic Mwape said that inspectors do not solicit for money when conducting inspections or get money, then he added that inspectors should be able to produce an identity card so has to notify that he is from the Authority and is an inspector²⁰.

For setting up a pharmacy, the Zambia Medicines Regulatory Authority has set up guidelines for the establishment of a Pharmaceutical retail business. And one of these guidelines is to pay for an Application for a grant of license for premises to be operated as a retail pharmacy which amounts to k5, 000.00 fees (1 fee Unit= K180) = K900.00 and also the fee of Inspection for grant of license for premises to be operated as a retail Pharmacy = 4,223 fees Units (1 fee Unit= K180) = K760.00 Total fees to be paid = K900.00 + K760.00 = K1, 660.00. These fees to an ordinary Zambian are too expensive for him/she to afford and therefore they opt not to do this and just start operating an illegal pharmacy or even forge the required documents. This has largely contributed too many persons operating an illegal drug store because they do not have sufficient funds.

5.0 SUCESSES AND FAILURES

In this chapter we will assess the success and failure of the Pharmaceutical Act No.14 of 2004; this is to help us understand its contribution to the Zambian Society.

Perhaps the biggest failure or gap is to facilitate legal sale of medicines in areas that are not serviced by registered pharmacists. The problem is best understood by considering observations of eminent persons on this matter. In the legislative deliberations prior to the 1940 act, Sir Leopold Moore, member of the legislative council and the first pharmacist in this territory then Northern Rhodesia, who opened the very first pharmacy in this country in 1905 stated that it would be practically impossible to administer any poisons law in this country²¹. According to him, no poisons law could work in this country as nobody could operate it because there were no pharmacists to run pharmacies in the territory as envisaged by the bill. He estimated that there were only two pharmacists in the country at that time in 1940. It was therefore impracticable and unjust to restrict supply of certain medicines [poisons] since, if the law was strictly applied, only two pharmacies would operate in the whole territory. This means that other towns, let alone small settlements, would have no access to drugs. Any access would be illegal. Indeed, the resultant law was not strictly applied. Indeed, even after the enactment, of the 1940 act, with only a sprinkling of registered pharmacists in a few pharmacies, the rest were run and operated by non pharmacists without any legal sumpsions. This remained the status quo 1990s. Colonel Stuart Gore-brown, a representative for African interests observed that most of those medicines that the Act sought to control were used by people in serious need.

The answer may lie in looking at how certain jurisdictions have dealt with this problem. In the United States of America, certain states have applied the principle of necessity with varying results. They start by recognizing that it is not possible to attract pharmacists and doctors to be in every community mostly for economic reasons. The community may not be affluent enough to generate enough business to support a pharmacist or a doctor’s practice. Secondly, the population may not be large enough to support the presence of a pharmacist or doctor. In certain districts, especially those that are sparsely populated, pharmacists cannot exist because there is not enough business to support them .even doctors’ clinics is non-existent. It therefore becomes necessary for the grocer to sell simple or ready prepared drugs²².Therefore, in the United States; certain states seized the initiative and legislated for just such eventualities. For example, a State of Wisconsin statute required different qualifications for pharmacists in towns of 500 or less²³. This would mean allowing assistant pharmacists, or pharmacy Technologists in this jurisdiction, to operate and run such pharmacies. This provision was affirmed in The State V. Evans²⁴adding that the statute was not invalid because it did not provide the manner of determining the population. In another case, The State V. Donaldson²⁵ in the state of Minnesota, shopkeepers who were more than one mile from a drugstore were allowed to sell common medicines and poisons under the rule of necessity. It was said to be reasonable in view of the necessities and convenience of those who resided at a distance from a drugstore. In yet another American case, it was held that sales of camphorated oil and essence of peppermint were medicines and prohibited from sale except by registered pharmacists and assistant pharmacists or registered assistant pharmacists. However, the prohibition did not apply to rural districts²⁶. In The people v. Roemer²⁷, in an action by the people of New York against john Roemer, section 234 of the public health law allowed, in places of 1,000 inhabitants or less, storekeepers were allowed to sell certain drugs specified by the board. The section allowed sell of certain classes of medicines or poisons but only in original packages. The court, in interpreting this provision, said that although the store keeper is not authorized to compound medicines, he is also for the quality and purity of all drugs sold by him subject to the guarantee of the drug.

“The question is whether for the sale of poisons and medicines which must necessarily mean prepared medicines[this is, such as do not require compounding by vendor], the state must compel dwellers in sparsely settled districts to resort to a pharmacy or drug store, however distant, for articles that may be needed for poisons or medicines. That would mean a farmer must go beyond his locality to purchase poisons used in his business, if a pharmacist has not settled within convenient reach, and that medicines sold in packages, however pressing the exigency, must under same conditions be sought beyond the locality. That would be a denial of the convenient purchase of necessaries and permit pharmacies, who shun scattering communities, to monopolies a trade at centers to which there traffic would not tend. Because a pharmacist must study and acquire knowledge to be such, it does not follow that some of his inferior powers may not be committed to the less trained men who reside were persons of his class do not carry on business’’.

The objective of the Pharmaceutical laws is to protect the general public from counterfeit, bogus or adulterated drugs. In Zambia, the law applicable is the Pharmaceutical Act No. 14 of 2004. We can see that the regulation in Zambia benefitted by drawing on the experiences of those countries which were more experienced in drug regulatory issues. As a matter of fact, most of the provisions that found their way into the Pharmaceutical laws were copied from the British statutes²⁸. The first ever law to try to regulate supply of medicines in Zambia was the Proclamation No. 21 of 1921²⁹. It was repealed by Act No. 38 of 1940, it repealed and replaced by the Pharmaceutical Act No.14 of 2004.

It is noticed that it is necessary to have a law that controls the supply of drugs. This ensures that safe and effective drugs are supplied to the public in order to safe guard their health. Strict enforcement of the law would disadvantage a huge section of the community, because certain areas do not have pharmacies and pharmacists. One way of remedying the problem is for the Minister to exercise discretion and recognize that in certain areas where there is no pharmacists, provisions are made for other health professionals to run medicines stores. And also in instance where there’s a pharmaceutical retail business operational but has no pharmacist, the government through the minister should identify such stores and deploy government pharmacist to help run and manage such shop in order to help the general public access safe and effective drugs from there’s stores.

There’s need to draw the experiences of other countries that have been in similar situations. The Americans have laws that allow certain stores that are not pharmacies to sell certain life saving drugs under the principle of necessity. In Tanzania they have what they call Accredited Drug Dispensary Outlets that are manned by other staff other than pharmacists. In both these places, there has been tremendous relief. This has been achieved by the law recognizing certain exceptions. Therefore the population that would be disadvantaged by strict application of unmodified law requiring a pharmacist gets services in these outlets.

Laws are supposed to serve the need of the society and not the society saving the law. Hence the Laws surrounding the operation of a pharmaceutical retail business need to be revised so as to to be up to date with globalization

BIBLIOGRAPHY

Hasumati Rahalkas, Historical Overview of Pharmaceutical Industry and Drug Regulatory Affairs, India, 2012

Law, Marc ‘History of Food and Drug Regulations in the United States’ EH Net Encyclopedia, Edited by Robert Whaples, October 11, 2004

Sifuna N and Mogeres, ‘Enforcing Public Health Law’ Zambia Law Journal Volume 34

Patrick Barton, ‘Quality of Quinine Preparation in Indian’ Medical Journal Volume 22 No. 1 of 2004

WEBSITES VISTED

History of Pharmaceutical Medicine www.drugstudt.md/resource9htm

National Assembly Debates 6^th August 2002

World Health Organization Summit 2008