Abstract

The medical practice is highly dynamic and demands that the professional exercise a high degree of discretion. Physician practice has been subject to regulation from time immemorial. Control of physician action through medical legislation and ethics has a long history and is not unique to modern society. In Cameroon, there are laws put in place regulating the sales and consumption of drugs. But however, the laws are not effective and inefficient. Not effective because there are a good number of clandestine hospital and clinics operating all over the national territory with numerous pharmacies selling drugs in all the towns and cities in Cameroon unpertop.

The research examines the regulatory and institutional framework on drugs in Cameroon as regards it sales or consumption. The methodology adopted is the qualitative research methodology where data was obtained through primary and secondary sources. The primary source of data was gotten from laws why the secondary sources of data is gotten from books, article journals, reports and online sources. Findings reveal that in Cameroon, there are different laws and institutions put in place to ensure drug approval, monitoring, and enforcement even though it is not without challenges.

Limited capacity to regulate medical products is associated with circulation of products which do not meet standards of quality, safety and efficacy with negative public health and economic outcomes. The research recommends that, there is a need for government to strengthen regulatory agencies responsible for overseeing drug manufacturing, distribution, and sales and also increase surveillance and enforcement measures to curb the influx of counterfeit or substandard drugs into the market.

CHAPTER ONE

GENERAL INTRODUCTION

1.1 Background To The Study

Pharmaceutical medicines generally speaking are devoted to the discovery, development and ethical promotion of safe use of pharmaceutical vaccines, medical devices . pharmaceutical products are substances or combination of substances which are presented for the purpose of treating or preventing diseases in human beings or animals with a view of making a diagnosis, correcting or modifying physiological functions in human beings or animals .

Since this industry is human centered, a lot of caution has to be followed to ensure that safety measures relating to human health and the environment are adhered to. Access to quality pharmaceutical products remains a significant constraint to the industry. The industry has been proliferated by hawkers who sell drugs of unknown origin in the markets. Control of these drugs and other pharmaceutical products have become a problem due to the limited capacity of the institutions mandated for such purposes in Cameroon. Against this backdrop, there is a growing need for regulations to govern the conducts of the various actors involved in this industry.

The falsification of drugs that are believed to cure illnesses is nearly as old as commerce itself. The falsification of medicines has not seized from time immemorial. Although it is extremely difficult to quantify the problem precisely, recent efforts by the WHO and others to support countries in tracking and reporting substandard and falsified medical products suggest the problem is on the rise.

This increase is also a result of globalisation and e-commerce that has increased the complexity of the supply chain for medicines, providing numerous entry points for unethically and illegally produced medical products.  Counterfeit pharmaceutical drugs are those medicines that are purported to be produced by duly licensed companies which in fact is not the case and are lacking in their ingredients or have more than required quantity of the correct ingredients and could therefore have more than usual adverse effects on humans when consumed. In fact, most of such drugs do not go through adequate clinical trials if at all they do.

Though it has also been noticed that some pharmaceutical companies found in country with stricter regulations are not lacking in the production and exportation of drugs that have not met the regulatory standards of their country to the African continent. These counterfeit medicines are often very lacking in their quality, efficiency and results. They are also known as illicit, falsified or substandard drugs and all fall under the term “defective” drugs. Illicit/fake medicines are among the counterfeit products with the greatest potential for harming the health of consumers.

The production of drugs is heavily regulated in order to ensure product compliance with the highest quality and safety standards. All drugs must undergo clinical trials before being marketed in order to test their efficiency, verify their quality and exclude the potential existence of side effects on patients. These institutional and technical measures are meant to work as a safety valve or precaution to guarantee the quality of medicines. Counterfeit pharmaceutical drugs do not respect any of these regulations and requirements.

Despite the existence of controls, counterfeit products exist in the market, creating consequences ranging from ineffective therapeutic results to severe health problems or death.  Access to quality medicines is indeed considered an integral component of the right to health, which is a basic human right that first emerged as a social right in the World Health Organisation’s (WHO) Constitution in 1946 and in the Universal Declaration of Human Rights in 1948.

It is recognised worldwide that health is a fundamental human right indispensable for the exercise of other human rights and that this right to health includes certain components that are legally enforceable. Quality pharmaceutical drugs are highly needed to ensure the health of sick persons. To meet this fundamental human right of access to quality, safe, and effective medicines, many countries have proactively developed pharmaceutical regulations to control their pharmaceutical market.

In many cases, the revision and improvement of national pharmaceutical regulations was also driven by tragedies. Cameroonian legislators have over the years enacted different pieces of legislation in order to better regulate the production, importation, distribution and retailing of pharmaceutical drugs. Although many millions of people still lack access to the basic medicines they need, the global trade in medicines has increased very rapidly in recent years.

Unfortunately, this growth has opened the door not just to quality, safe and effective medicines, but also to medicines that do not meet quality standards and that are sometimes toxic. In the worst cases as earlier mentioned, medicines that contain the wrong ingredients may kill or seriously harm patients. Much more commonly, substandard or fake medical products will fail to prevent or cure a disease, meaning that illness is prolonged and the patient suffers needlessly.  Access to proper healthcare is a fundamental right but for too many people, especially in Africa and Cameroon in particular, their health and their lives are put at risk by the traffic in substandard and fake drugs .

Persons with very little or no training in medical science and pharmacology in particular have seized many opportunities due to the lucrativeness of this industry to manufacture low quality drugs for marketing. Others have indulged in the trafficking of illicit drugs into the country. The consumption of low-quality drugs reduces the lifespan of people and increases the rate of mortality of otherwise healthy persons.

Formal private sector pharmaceutical retailing in most countries, including Cameroon is governed by regulations that prescribe ownership, staffing, acceptable medicines along with sources and quality standards, pricing and prescription practices. This prerogative in Cameroon is left at the hands of the Ministry of Public Health. This ministry has the duty to ensure that medicines are dispensed by qualified and registered pharmacists and the sale of illegal, out-of-date, or non-prescribed medicines is prevented.

Pharmaceutical drugs regulations, or medicines regulations are combination of legal, administrative and technical measures that governments take to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information. The term “regulation” includes a variety of texts  that have different legal bases and authority. Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy.

The constant trafficking of illicit medical drugs into the country and the production of counterfeit drugs greatly affects the health of individuals. It hampers effectiveness in health delivery and threatens the lives of consumers. Medicinal products are not usual “commodities.” In fact, they are some of the most regulated marketable products as they provide fundamental health needs to the public, and their evaluation and control require a high level of expertise. Because of the awareness of the strict regulatory measures put in place due to the nature of the “products”, and especially in the present situation of need, producers of counterfeit medicines in a bit to make profits have increased production of such drugs.

It is even found that some of these sub-standard drugs are produced by already authorised pharmaceutical manufacturers without adequate testing and mixed amongst the already well produced drugs in order to increase profits. Regulatory oversight is constrained by government’s lack of enforcement staff, budgets, or efficient regulatory and judicial framework that exists.  Regulatory inspections are few, enforcement is weak and infringements common.

Enforcement is made particularly difficult because the pharmaceutical retail market is fragmented; the number of formal pharmacies is small compared to the many different types of retailers, such as dispensing doctors and other health personnel, medicine stores, hawkers and general grocery stores that also sell a variety of drugs and healthcare remedies. The result is widespread unregulated and sometimes illegal sale of restricted medicines, often without prescription and often by unqualified staff.

As such, there is little, if any, quality control and retail prices are inflated and highly variable according to the need. Regulation of the pharmaceutical industry or drugs is therefore an essential tool in combatting the sale of low quality, smuggled and dangerous drugs in the retail market in Cameroon. The Ministry of Public Health has to ensure that the procedures put in place for production, importation, distribution and sale licensing is adequate and functional for effective regulation so as better control and combat this age-old ill hampering the society.

1.2 Statement Of The Problem

In Cameroon, there are laws put in place regulating the sales and consumption of drugs. But however, the laws are not effective and inefficient. Not effective because there are a good number of clandestine hospital and clinics operating all over the national territory with numerous pharmarcies selling drugs in all the towns and cities in Cameroon unpertop.

As if that is not enough, quacks have the habit of moving from one market to another on market days selling drugs and treating patients, especially on market days. In addition, almost all provision stores selling goods or articles in the quarters also sell drugs to people without any caution. Furthermore, professional drivers who know nothing about medicine or treatment are permitted by law to move along with drugs in their tool box usually termed first aid box.

Although, first aid box is important if an accident occur, and any driver or persons administering any drug to an injured passenger should at least have a basic knowledge about medicine. With regards to the efficiency of the laws regulating the practice of medicine in Cameroon, it seems the laws are inefficient because the above illegalities in the practice of medicine in Cameroon has been going on for a very long time and till date very little has been done by the government.

1.3 Research Questions

1.3.1 Main Research Question

How effective is the regulations of drugs in Cameroon?

1.3.2 Specific Research Questions

1. What is the conceptual and regulatory framework for the sale of drugs in Cameroon?
2. What is the institutional framework regulating the sale of drugs in Cameroon?
3. What are the policy recommendations to resolve the problems raised?

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