All medicines have an international non-propriety name, commonly referred to as ‘generic or chemical name’ in addition to a brand name that is proprietary to the pharmaceutical company. A good example is ‘paracetamol’ that is famously branded as Panadol and Calpol in different parts of the world. Consumers, pharmacists and prescribers often have different preferences for a brand, and similar to the brands in consumer goods industry, often branded medicines are expensive and often have a perceived impression of good quality among consumers and prescribers. The question often asked by the public and governmental organisations is whether the branded medicines are really any better than the cheaper generics or is it just a consumer or prescriber’s perception?
To bring this into perspective one must understand how new medicines are discovered and how their generics are introduced. The innovator companies invest millions in drug discovery to bring new molecules from the laboratory and preclinical evaluations in animal models through to the clinical trials. It usually takes about 10 years to get a new drug to the market, costing millions of dollars to meet the toughest safety and efficacy standards imposed by the drug regulatory authorities. A stark reality is that majority of the new drugs and molecules do fail during their journey and never make it to the market. This highly risky investment in pharmaceuticals rarely produces a successful candidate that reaches the market. This new medicine then becomes the intellectual property of the innovator company who in return enjoys the sole right to manufacture and sell the new drug product throughout its patent life, which usually lasts for 20 years. However, to protect the return on investments, often drugs are patented very early in the discovery stage, therefore, by the time a product is launched in the market, there is often a fraction of the patent life left for the company to get the return of their extensive research and product development costs. Once patents are expired, other companies may then start producing the same product, often referred to as generics. The drug regulatory authorities, like FDA or EMA in their respective jurisdictions, ensure that these low-cost alternatives (aka generics) meet the same standards of quality (similar safety and efficacy) as of innovator’s product. These generics are priced much lower than the innovator’s product, as these generic manufacturers do not invent new drugs, and their costs are mainly attributed to standard manufacturing operations. Generics are always given preference, wherever possible, in countries like United Kingdom to reduce the cost of therapy and burden on national health services.
Consumers, and healthcare professionals’ perception of generics
The research has shown that consumers and healthcare professionals often have several misconceptions about generic medicines across a spectrum of low-, middle- and high-income countries. It is, however, acknowledged that consumers acceptance of generics largely depends on pharmacists and prescribers’ recommendations. Over the years, patients’ and prescribers’ confidence and knowledge on generic medicines have improved, particularly in the developed world, however, more work is needed in LMICs. The lack of the acceptability of generics could lead to non-concordance (therefore, treatment failure) and is counterintuitive on treatment costs. Studies have indicated that interventions such as education, financial incentives, and better communication between patients and healthcare professionals has improved the confidence on generics.
So, if innovator brands are expensive and generic products provide a low-cost alternative, then it should make sense that the DRAP has decided to direct all clinicians in Pakistan to prescribe medicines by their generic names. It is true that in many countries, for instance in United Kingdom, generic prescriptions are a norm in the general medical practice but there are serious issues that needs to be considered when it comes to legally enforcing generic prescribing in Pakistan. This is also common across a spectrum of LMICs.
