Research has shown that generic drug substitution could reduce costs to patients, by an average of 60 percent.
The manufacture of generic medicines, however, is no open cheque to any would-be manufacturer.
We might have all had this conversation with our local pharmaceutical superintendents regarding our prescription as to whether to be buy an “original” or a “generic” and we have always bargained for the former.
This, no doubt, is founded on the impression that generic medicines, could be less safe, less effective and of lower quality than their equivalent branded counterparts or originator products as commonly referred to. Nothing could be further from the truth.
Typically, generic medicines sell for lower prices than the original branded versions. Obviously then, consumers would be opting for generics but many believe that less expensive equals lower quality. Generic medicines can effectively treat any illness.
Therefore, with many economies still reeling from the Covid-19 effects, the generic substitution would come in handy to ease economic pressure on drug budgets, especially in developing countries. Research has shown that generic drug substitution could reduce costs to patients, by an average of 60 percent.
But how then do generics come about? Generally, upon patent expiry, patented technology is always available for exploitation by anyone.
As such, generic medicines are products, of the expired original patent that are now available for exploitation by other manufacturers, other than the original innovator (patent-holding) company.
The manufacture of generic medicines, however, is no open cheque to any would-be manufacturer. To obtain the necessary regulatory approvals, a manufacturer must prove the quality, efficacy and safety of their products.
This involves rigorous studies on the formulation of the product, performance of stability experiments and undertaking of bioequivalence studies.
A lack of proper information has aggravated the perceived doubts regarding the quality and equivalence of generic medicines.
The provision of information and education by healthcare providers, especially in the areas of equivalency, regulation and dispelling myths about generic medicines would boost confidence in generic drugs.
Owing to the rigorous regulatory processes involved before approval of generic medicine, and in order to avoid any intellectual property infringement for acts relating to the development and submission of testing data to a regulatory agency, there are legal exemptions from infringements popularly known as “Bolar Exemptions”, thanks, to the flexibilities granted under the World Trade Organization (WTO) agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).
With the “Bolar” provision, a generic producer is thus able to undertake all the required tests including developing a product before the expiry of the patent. This permits a generic producer to market its products soon after the expiry of a patent period.
Whereas there is no doubt that branded medicines have presented tremendous influence in the utilization of medicines, generic drugs, as bioequivalent to their brand-name counterparts, are considered safe as well as cost-effective.
With the obtaining safeguards involved, there is no doubt that generic medicines provide a safe and economical medical treatment fit for a developing county, such as Kenya.
Globally, greater emphasis is presently placed on the usage of generic medicines by governments focused on the potential economic benefits associated with their use; generic medicines provide the opportunity for major savings in health care expenditure directly to the consumers as well as to the government, given that they are generally lower in price than their brand-name equivalents.
Duly approved generics, however, should thus be distinguished from counterfeit or falsified drugs, which are harmful to patients as their quality, safety and efficacy cannot be guaranteed.
Whereas some consumers could be knowledgeable on generic medicines, consumption of medicines has always been informed by the prescribing behavior of physicians who dictate the prescriptions.
The complex nature of pharmaceutical sector patients’ attitude towards any changes to their prescriptions compounds the situation. In the totality of all this, patients should avoid self-prescriptions and always be guided by professionals.
Additionally, direct patient education by the healthcare providers on issues relating to safety and efficacy of generic medicines could further enhance their uptake.
