Despite their persistence, doctors around the world have recognized that diseases and epidemics like HIV/AIDS are a disaster and the need to create a cure has literally dragged scientists into experiments and medical tests, including tests on humans.
In Uganda, the Walter Reed Project is very vocal and active in carrying out drug tests, hoping to find a cure. Their efforts have led them to solicit for volunteers to assist in several ways. One of the policies held by projects like the Walter Reed Project is the affirmation to human subjects/volunteers on the safety of the drugs used. This is vital and prudent of them.
However, for ‘would-have-been-volunteers’ like Maiso, the whole process is confusing.
Maiso, a boda boda rider in Kampala’s slum of Bwaise gave me a lift (paid for with legal tender, of course) to Kampala Capital City Authority offices. While at it, I eavesdropped on my quick telephone conversation with a friend who wanted to know which law gave projects like these the right to carry out field tests and to have human subjects in those tests.
‘Those things are for con-artists’, he said, in slang Luganda. ‘Con-artists’ are called ‘bafere’.
‘Which things?’ Honestly, I did not think he was that keen on my phone call since I figured he was maneuvering through heavy traffic at Clock Tower.
‘The human tests.’
Setting a conversation mood on a dusty ride in the city is not fun. But I have learned in my practice not to brush off just anybody. [Disclaimer: ‘I am not yet an ambulance chaser.’]
Somewhere in our brief conversation, Maiso expressed little confidence in the viability of the drugs, the genuineness of the medics involved and the intention of researchers and government. He even smirked at the thought of the government harboring ulterior motives to de-populate the country.
Minus the emotional turmoil that could not be helped at the time, I told him about some of the mechanisms the government, scientists and investors use to tackle a social problem like the one at hand. He did not seem doubtful and I hoped to share it with our readers.
Disease out breaks and the Law
The recent surge of different diseases and medical intrigues made it necessary for scientists to invent new classes of drugs to curb the disease outbreaks.
It is now common to find or hear about diseases spreading or recurring. Zika, in Latin America (reported to have been first sighted in Uganda), Ebola all over Africa and especially the success in medicines invented or improved by scientists and medical researchers in Uganda and elsewhere, etc. are good examples.
These outbreaks however are monitored by the medics and the state which collaborate to eliminate catastrophes. But they come at a cost and often require human test subjects to develop advanced drugs in the run.
Uganda’s law touching on drugs and the processes involved is the National Drug Policy and Authority Act, Cap 206. There are several other Regulations that support this main law. We will handle some of them in these series; but will briefly look at the one that requires vigilance on monitoring drug use, efficiency and viability;
The National Drug Policy and Authority Act, Cap 206; and
The National Drug Policy and Authority (Pharmacovigilance) Regulations, S.I. No.8, 2014
The Act establishes the law governing the drug industry in Uganda and the Regulations provide for the physical handling of the processes involved therein.
Section 64 of the Act, Cap 206, establishes the Regulations which provide for several regulations the Authority operates under. When looking at the laws, it is imperative to understand the meaning of the terms therein because they are the terms that the medical industry uses when handling medical researches, tests/field trials, reports, contracts with human subjects/volunteers, etc.
A drug is defined under Section (1) (k) of the Act, Cap 206 as;
‘…any substance or preparation used or intended to be used for internal or external application to the human or animal body either in the treatment or prevention of disease or for improving physiological functions, or for agricultural or industrial purposes’.
This means (Regulation 2);
“…the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug related problem.”
- Adverse drug event
This term under the regulations’ interpretation clause means;
‘…any unwanted medical occurrence in a subject to whom a drug is administered and includes an occurrence which is not caused by or related to the drug.’
- Adverse drug reaction
This term means;
‘A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis (medical lingo that is too advanced for the author but thanks to google.com means ‘action taken to prevent disease, especially by specified means or against a specified disease’), diagnosis or therapy of disease or for the modification of physiological function.’
- Counterfeit drugs
These are drugs which ‘deliberately or fraudulently’ mislabel with respect to the identity, content or source (Regulation 1).
- Periodic safety report
This is ‘the report on the safety experience of a drug at defined times, after the drug is registered.’ (Regulation 1)
Why Clinical trial projects require pharmacovigilance system
The human anatomy is a sensitive matter which must be delicately dealt with. All persons who specialize in the medical field where a human being can be a subject must be skilled enough to carry out their professions. No wonder they take long in medical school. That is how important your body means to science.
Systems to ensure safety of the drugs used in human test trials are fundamental in preserving the human body in its form. Because of disease, science and her followers assume the responsibility of researching and testing possible medical solutions to these diseases.
This explains why the investment in the medical industry has escalated over a couple of years. The level of medical research in the facilities is advanced. Lately, it looks like cancers and tumors have seconded HIV/AIDS in the medical research facilities and investment budgets.
Regulation 3 provides for requirements for a pharmacovigilance system. These include:
- A License: To formally operate a drug related activity especially for human use. A license is issued to professionals who know the efficiency, safety and quality of the drugs to be used.
- A Licensee: A skilled person trained in handling drugs to be used. For example, doctors, nurses, or other health professional.
- Investigations for adverse drug event: Where adverse drug reaction is reported, it must be investigated. Drugs that do not comply with their alleged composition, licences; those that the international community call into question (issue an alert), drugs that are recalled for any reason or as the Authority decides, etc. will be investigated. (Regulation 5)
- Reporting on counterfeit (Regulation 7): Health professionals and any other licensed person are obligated to report to the authority about a suspected counterfeit drug.
*It is illegal to deal in counterfeit drugs (Reg.7.2)
*The authority is permitted to confiscate any counterfeit drug (Reg. 7.3)
*Withholding safety information and obstructing a licenced officer from obtaining information about a drug is an offence (Regulation 9) and is actionable in court.
The principles of protection of Intellectual Property govern the medical industry. Because inventions are *novel, have * inventive step and are *industrially applicable, counterfeit drugs flood the market due to the demand for cheaper drugs in mostly developing countries.
However, this point does not excuse production of counterfeit drugs which are potentially harmful to the human body. Uganda’s Industrial Property Act (IPA)  provides for laws regulating pharmaceutical businesses and therefore, clinical trials on human beings ought not to frighten volunteer subjects.
There are instances where the Authority recognizes that the drug intended for use is not viable enough. It usually requires the drug handler to submit periodic safety reports or other reports for monitoring. The reports can be annual, bi-annual, quarterly or as the Authority orders.
Eventually, a test human subject will feel safe once he/she knows and understands that the authorities responsible are concerned for his/her wellbeing and are vigilant on the tests and the persons carrying out the tests.
The drugs we use today had to undergo tests from animal to human subjects at one point. They would not have been placed on the market if the professions concerned had not confirmed their safety. If Maiso, my boda boda rider had volunteered, such information would have been availed to him.
Scientific tests are not only costly but also frightening to non-medical personnel.
Non-medics feel safe only after receiving confirmation that the types and classes of drugs used or to be used are safe for human consumption and in case of adverse drug reactions; the very medics concerned have alternatives and first aid kits at hand.
However, the importance of a contract cannot be overlooked.
Scientific experiments on human test subjects must seek for and receive consent from the volunteers/participants. Absence of which, the law will assume a fundamental breach of the Right to Life and hand down penalties for such breach. This is how we can trust the system.
Next week, we shall briefly look at the Ugandan law on actual clinical trials and what an intending human subject must know before he/she volunteers his/her body for experiments.
BY ATUHAIRWE AGRACE
This article appears in our digital law newsletter, The Deuteronomy Vol 6, Issue 2 of June 9th, 2017
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