clinical trials

The Ugandan law on conducting clinical trials

What an intending human subject must know before he/she volunteers his/her body for experiments.

After a laborious ride and chat, Maiso finally confessed that he separated from his live-in baby mama for volunteering to be a test subject in an HIV/AIDS human trial a year earlier.

“She could have infected me”, he said.

“But those trials are usually safe.” I ignored my own qualms.

Before long, his emotional baggage had rifted to some kind of fear I only watch on mini-series on Aliens and human experiments.

“That ‘insect’ is ferocious,” he went on, baptizing the virus with the many local terms for HIV. “They don’t tell you until you hear the drug was faulty: you have to return for emergency drugs: blah blah blah.’ His anger accelerated.

“I cannot say, Ssebo”, I wasn’t sure of my opinion at the time. “Trials are trials.”

“See my fear?” He gained confidence. “I figured she would hop around the neighbourhood, get infected and then gladly give me some of it. I have young children to take care of. I quit women.”

***

Clinical Trials

The National Drug Policy & Authority Act and the National Drug Policy & Authority [Conduct of Clinical Trials] Regulations, 2014 govern the conduct of clinical trials in Uganda.

It is possible to deny their existence because not many from the public spheres have heard about it. However, knowing that the government does not permit human clinical trials without conducting proper procedures can be comforting to its people.

It is also important to know some lingo used in this sphere of science. These lingo/terms are used in the contract that any volunteer signs are important because they help any participant to know how the system operates. Besides, without understanding fully what such a medical process involves, several firms have and individuals have faced legal suits. Among the many terms, (all under Regulation 2 of the Regulations), the following are vital:

  1. A “Clinical Trial”: means an investigation in a human object which is intended to discover or verify the clinical pharmaceutical or other pharmacodynamic effects of an investigational drug product or to identify any adverse reactions to an investigational drug product.’

People like Maiso may not fully grasp the intense language in the definition.

Literally, a clinical trial is where doctors/medics test the viability or effectiveness and vice versa of a drug in human subjects.

  1. “Consent”: means a written, signed and dated voluntary confirmation by a subject about his or her willingness to participate in a clinical trial, after being informed of all the aspects of the clinical trial that are relevant to the decision to be made by the subject regarding his or her participation in the clinical trial.’ [emphasis added]

In two of our previous articles, (see The right not to be subjected to medical experimentationandLimitations to the right to consent to treatment), the author discussed the importance of consent.

Consent is a fundamental factor in several human relationships and transactions.

It is assumed that sane adults have rational understanding of their actions and therefore can decide whether or not to partake of any activity.

‘Mens rea’ and ‘Actus reus’

In court, we call this ‘mens rea’ [intention]. Before we conclude on matters in legal corridors, we must exhaust two factors, the ‘mens rea’ and the ‘actus reus’ [act]. One act must lead to the other. In criminal law, the two factors impute whole liability to the party accused of an offence/crime.

Sometimes, the ‘mens rea’ is absent and the ‘actus reus’ present. Summarily, after examining the evidence on record, a lesser penalty is usually pronounced. This is how important the state of one’s mind is in legal procedures.

Similarly, in scientific spheres where ‘doctor-patient’ relationships appear, it is important to infer a common intention and willingness to continue this kind of relationship.

  1. “Investigational drug product”: means a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial and includes a registered product when used or assembled or formulated or packaged in a way different from the approved form, or when used for an unapproved indication  

Human subjects cannot be subjects without an actual drug to test. Normally, scientists first conduct trials on other subjects like animals (rats, anybody?). Once they confirm that the drug works well with animals, whose genetic composition is similar to humans, they carry on with human test subjects.

Various reasons encourage them to do so. Whichever reason, it is important to test on human subjects as a last resort and after successful tests on other mammals to ensure greater chances of human preservation.

  1. “Serious adverse events”: means any prolongation of existing occurrence that at any dose-
  • Results in death;
  • Requires in subject hospitalization or prolongation of existing hospitalisation;
  • Is life threatening;
  • Results in persistent or significant disability or incapacity; or
  • Results in a congenital anomaly or birth defect.

The most important thing is to understand in all clinical trials is that there is a new or improved drug, which requires to be tested before it is placed on the market as a cure or aid to a disease.

As earlier mentioned clinical trials are administered with the consent of the subjects. Any coercion is abuse of human rights and therefore actionable in court. Plus, the drugs used are not the cure but part of the results got from laboratory testing for certain ailments.

Also, clinical trial drugs must be carefully used on human subjects with preventive measures in case something adverse happens.

Chances of adverse effects are existent but should not be too difficult to reverse.

Regulation 3 provides that:

The trials must be authorised by the Authority after they have presented documents which prove;

  1. The drug indications and clinical use
  2. The target subject population
  3. Routes of administration
  4. The dosage
  5. The dosage Form for the drug which the Act stipulates is allowed.

This information (Regulation 4) must also mention;

  1. The holder of the patent of the drug
  2. A licensed person
  3. The manufacturer of the drug
  4. An agent of the holder of the patent or the manufacturer of the drug.
  5. “Sponsor”: means a person who is responsible for the management and financing of a clinical trial.

Large pharmaceutical companies, wealthy individuals or corporate donors and states can be sponsors of a clinical trial.

Sponsors will fund the project and will be some of the parties to sue when something goes wrong because they are directly linked to the whole process.

Often, they provide upkeep or compensation to both subjects and the subjects that may be victims of clinical trials gone wrong.

  1. “Subject”: means a human participant in a clinical trial.

Basically, it is you, who volunteers to be the subject of drug testing. So, it is not like they will call you by name because they usually use codes. But you are the specimen. It is okay to investigate everything about the trial because you will be the one harboring the chemicals, syringes, pills, rubbers, etc. and consuming inquisitive visits.

Conclusion

Your life is valuable.

Without exhaustive information on the uses, effects and viability of any drug, you are free to reject any tests on your body. However, should you volunteer to do so, consult medics and seek counsel from a lawyer to understand the risks involved.

For many, it can be a ticket to reckless living or a quick profit, but human trial tests enable scientists produce more effective drugs and hopefully, ones that will eventually be readily available to all at a fair cost, regardless of social status.

My boda boda rider who confessed to me that he had ‘quit women’ gave me an afternoon of thoughts. He left me wondering many things. Was he getting pleasure from the goddesses of the night and streets? That was equally risky. Was he sneaking into some other man’s house to catch a romp with the lady of the house, house-help or child? I tried not to roam with those thoughts.

BY ATUHAIRWE AGRACE

This article appears in our digital law newsletter, The Deuteronomy Vol 6, Issue 3 of June 16th, 2017

To receive The Deuteronomy in real time, click HERE

 

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