Generic Medicines And Their Role In Health Care

Image Credit: By Alex Khimich [Public domain], from Wikimedia Commons

Healthcare is increasingly being recognized as a right rather than a luxury. Medications are the backbone of any health system. Without an abundant supply of good quality medications, even the best of healthcare providers can not function and save lives. Saving lives requires systems where the right medicine is produced and is supplied at the right place and used in the right patient in the right amount at the right time and right cost.

Healthcare issues are also increasingly capturing the attention of mainstream media and one of their favorite topic is "Generic Medicines". While their headlines are great and eye-catching, the content usually surrounds controversies and commentaries.
Social media also joins mainstream and people jump and take sides to pronounce judgment on who's right. Sadly, the topic suffers from all this activity. This article makes an attempt to provide you with scientific details on "Generic Medicines".

What does "Generic Medicine" mean?

Medicines are chemical agents and are derived scientifically, i.e. discovered or invented (Innovated). Drug innovation takes huge efforts and resources. Therefore, one who does this needs compensation and reward to continue doing it.
The compensation for innovation is usually in the legal form of intellectual property rights, called "Patents" that are awarded for specific time frames. During the life of such rights, no other entity can manufacture and supply the drug.
Generic medicine has been defined by various expert bodies like the World Health Organization, US FDA, European Medical Agency, etc. These definitions are complex and reproducing them here will not serve the purpose of easy understanding.
A simple derivation of the generic drug from all these definitions would be "A drug that is not protected by intellectual property rights anymore, and can be manufactured and supplied freely, by anybody who is competent, qualified, and is able to prove the identical nature of generic drug with reference innovator drug and can be used interchangeably in patients with the original innovator products ".
Because intellectual property rights are awarded for fixed time frames, most medicines across the world that are manufactured and supplied are "Generic and Off-Patent" in nature.

What are the advantages that are offered by generic medicines?

A very important result of medicine losing its intellectual protection is the entry of competitors, that pushes the prices down. Thus, entry of a generic drug pushes down the price of the original innovator drug.

Generic medicines offer reduced prices, increase access to pharmacological therapy, provide a stimulus for innovation by both originator companies and generic companies, and may have a positive impact on medication adherence.

Should generic medicines be equivalent to the original innovator product?

By definition, generic medicines should be equivalent to the innovator product in terms of dosage form, strength, route of administration, quality, safety, performance characteristics, and intended use.
Generic medicines are chemically identical to their branded counterparts, but, they appear different in size, shape, and color, in compliance with the law.
Marketing approvals for innovator drugs are usually granted by regulators after usually checking effectiveness and safety in patients. Whereas, marketing approvals for generic medications are usually granted by regulators on the basis of few bio-equivalence studies involving healthy people.

Do generic medicines show equivalent clinical results as their innovators?

To date, only a few research studies have been published in this regard. The results have not shown huge differences but no generalizations can be made in this regard and more research is needed.

What do doctors and pharmacists think about generic medicines?

A recent study showed that doctors and pharmacists from less mature healthcare systems have mixed feelings towards generics because of poor controls, and manufacturer standards. They also mention that there is a lack of reliable information and mistrust in efficacy and quality.

In the most developed healthcare systems, the participants trusted the quality of the generic drugs and did not hesitate to offer them to all patients regardless of socioeconomic status.

The main difference between high-income countries and low and middle-income countries is that physicians from high-income countries generally have positive views whereas those from LMICs tend to have mixed views regarding generic medicines.

Where are major markets for generic drugs?

The major markets of generics include the United States of America followed by the European Union, Canada, Japan, and Australia. The major suppliers of generic medicines are China and India.

What are the names under which generic medicines are sold?

Generic medicines can be sold under two names. Firstly, generic medicines can be sold under the "Generic Name", that is a common name, referring to the drug or salt inside the tablet. This type of selling under a generic name is only adopted by a few manufacturers for a few clients.
Secondly, generic medicines can be sold under the "Trade name " or "Brand Name", that is a trademarked name that no other manufacturer can use. This type of selling is more commonly adopted. Such generics are also known as branded generics and the purpose is to create value in the eyes of consumers/customers.

About the author: Dr. Naval Asija is a licensed MBBS Physician from India. MBBS is the equivalent of the MD degree offered by international medical schools. He is based in Delhi, India, and works as a medical writer, editor, and consultant. He supports medical researches as an author's editor, medical communication companies involved in medico-marketing activities, and medical technology companies in improving their products. He can be contacted via his LinkedIn Profile: https://www.linkedin.com/in/navalasija/

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