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The final chapter: Ethics of pharmaceutical product development and accessibility to all

 

It has been a bioethical journey, figuring out what is the right thing to do around several legal, social, and philosophical issues with the help of highly skilled panelists from various medical and related fields. Every two weeks, individuals, both professionals and students, came together to hone their knowledge to create social impacts with it. To ask questions and share opinions, up until the 11th session held on 22nd April 2021.

The Bioethical webinar series has been a joint project of Fanusi Study Centre and Strathmore University’s Institute for Family Studies & Ethics (IFS), whose aim is promoting the wellbeing of families and individual members of society in Kenya and beyond. Fanusi is a project of Kianda Foundation Educational Trust in Nairobi, Kenya. It aims to encourage the all-round formation of university women.

The final session revolved around matters involving ethical pharmaceutical practice. In attendance was Dr. François Franceschi, project leader for AMREP at Global Antibiotic Research and Development Partnership (GARDP); Dr Bernhards Ogutu, Chief Research Officer with KEMRI and scientific team leader of the Centre for Research in Therapeutic Science based at Strathmore University.

Is safety compromised?

Often when we purchase medicine on prescription or over the counter, we may make an intrinsic complaint that medication costs are ever-rising, worse off if you are catering for the charges off pocket. We, however, may not realize how much goes into the process of having that syrup or pill ready for consumption to combat whatever one may be ailing from.

Dr. Franceschi highlighted the steps taken before approval of medication which included four stages of testing the vaccine/drug on volunteering persons. An important matter in question was the COVID-19 vaccine – produced, tested and, approved at record speed. How safe is it if it happened so fast?

Once again, Dr. Franceschi took the audience step by step: The timeline hastened but never cut corners on safety. First of all, we already had helpful information – about coronaviruses, so the scientists were not starting from scratch. Secondly, many people participated in clinical trials, saving time for looking for volunteers. Third, various governments worldwide invested a huge amount of money to support vaccine companies with the work. Fourth, manufacturing was carried out (at risk) at the same time as safety studies, therefore vaccines were ready to be distributed once they had authorization for emergency use/approval.

He added, “After the approval of the drug/vaccine, it undergoes phase 4 trials. The main objective of the trial is to check the drug’s performance in real-life scenarios. It involves studying the long-term risks and benefits of using and discovering any rare side effects. After which, post-approval commitments follow. It is, however, possible for approval to decline as was in the case of Drotrecogin (Xigris), a drug for sepsis in 2002.” Based on his information, we are more likely than not to be looking towards post-approval commitments with the COVID-19 vaccine soon.

How much of a luxury is medicine?

According to MSF Access Campaign (1999), there were challenges observed when observing and treating patients. Unaffordability and Unavailability / Un-adaptability of medication – research and development do not target the medical needs of the poor patients for example, neglected tropical disease and heat-stable vaccines and therapeutics.

“Not all Member States even in the WHO European Region have mechanisms in place to evaluate the cost-effectiveness and decision-making processes to the determination of patients at the national level,” Dr Ogutu said. Solving the matter, Dr Ogutu shed light on mitigation measures used to improve access to medicine. “Compulsory licensing under the flexibilities in the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been used to allow generic pharmaceutical producers to use patented technology for the production of cheaper, generic versions of pharmaceuticals.”

Prior to this pharmaceutical webinar, the series had tackled matters human dignity; role of conscience, Euthanasia, Humanae Vitae and the natural regulation of the use of fertility, Abortion, Assisted reproductive technology, and IVF and surrogacy. We look forward to more of these impactive and informative sessions that freely tackle issues hardly talked about openly.

 

To access the recording of this webinar session, click here.

 

This article was written by Anna Jessica Munya.

 

If you have a story, kindly email: communications@strathmore.edu

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