Dr J Vijay Venkatraman, MD and CEO, Oviya MedSafe and Karunakaran Shanmugam, QA Associate, Oviya MedSafe, advocate implementing pharmacovigilance in a prudent manner to augment the growth of the Indian pharma industry
Pharmacovigilance (PV) is a scientific discipline that significantly impacts public health. It involves several stakeholders such as the pharmaceutical industry, academia, healthcare professionals, consumers and drug regulatory agencies. Pharmacovigilance is often perceived by pharmaceutical companies as an obstructive regulatory ordeal rather than an integral pre-requisite for marketing their products. The traditional perception that PV is a cost centre that does not generate any return on investment is so deep-rooted in the industry that the title of this article itself may seem oxymoronic to many. However, the practice of performing pharmacovigilance in a prudent manner may rather be an augmenter for the pharma industry, which this article explores in detail.
The World Health Organization (WHO) defines PV as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The specific aims of PV are to:
- Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions,
- Improve public health and safety in relation to the use of medicines,
- Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and
- Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
The above-said objectives should be considered the cardinal responsibilities of all PV stakeholders who can never be justified in compromising on their duties. As any other PV stakeholder, the pharmaceutical industry is also bound to fulfil these obligations. In fact, patients are entitled, as customers, to expect accountability on the part of pharma companies, in cases of any complaints. But, this has led to the unfortunate interpretation of the pharma industry that PV is a detrimental activity that could challenge their prosperity. However, what has not been realised yet is that PV can also add significant value to the pharma industry beyond its commitment to being the custodian of patient safety.
Value addition is defined as the increase in value of a product or service as it goes through the stages of being developed and produced. Value-added products or services are worth more because they have been improved or had something added to them. In other words, value addition is something that justifies the higher worth deserved by a product or a service which has the value added feature versus a similar product or service that does not have it.
Given this background, adoption of the principles of PV may be considered to add value to the concerned pharma companies by:
- Enhancing corporate image;
- Ensuring financial security;
- Envisioning scientific challenges; and
- Enabling business expansion.
Enhancing Corporate Image
Corporate image or reputation denotes the way in which a business house, its activities and its products are perceived by outsiders. Corporate image is a composite psychological impression that continually changes with the company’s circumstances, media coverage, performance, pronouncements, etc. In a competitive business scenario, many businesses actively work to create and communicate a positive image to their consumers, shareholders, regulatory authorities and the general public. A company that allows its corporate image to be messed up is more likely to find itself in a variety of problems. PV is an enhancer of corporate image in the following aspects:
- A company performing good PV is seen as a responsible and patient-centric organisation — In case a patient develops an adverse event following the intake of a particular drug and contacts the concerned pharma company, a prompt and appropriate response is bound to make them feel cared for.
- News of non-compliance has worldwide impacts on the reputation of the company — History has shown us that share prices of pharma companies have crashed overnight following revelations of compromises in handling product safety data. Such impacts are not restricted to a particular region or country because in today’s electronic era, it takes little time for news to spread globally. This is of particular concern as most pharma companies operate in multiple countries.
- PV is seen as surrogate marker of quality — Pharma companies usually prefer to highlight information on their quality standards, especially on their compliance with Good Manufacturing Practices (GMP) and certifications like ISO (International Organisation for Standardisation), on their websites and other business literature. If some information on their PV system is also provided along with these details, the consumer would feel that the company is quality-conscious, because for the patient, quality is a combination of both efficacy and safety.
- Projects the company as a science-focused organisation — Consumers tend to believe that a company that vigilantly researches on their negative feedback is driven not only by business motives but also focused on science. While this is true for any industry, this attitude is more desirable in the pharma domain where the company directly deals with the health of its consumers.
Ensuring financial security
Every pharma company wants to be financially secured by preventing loss due to safety-related product recalls and consumer lawsuits. Such scenarios will also lead to decline in company sales, share prices and erosion of shareholder wealth.
It is a fact that no drug exists without its adverse effects and therefore, no pharma company will be penalised just for encountering an Adverse D