Exploring options: branded versus generic medicine۔۔۔۔۔ Dr Baber Saeed Khan
Ritu, a 7-year-old girl from Tharparker, felt excessive thirst with frequent visits to the toilet, looking weak and feeling confused, eventually visited the hospital along with her parents. The resident doctor examined her and prescribed a few tests. Shocking for everyone, her random blood sugar came out to be 460 milligram percent. She was investigated and was diagnosed as suffering from Type 1 Diabetes. The doctor informed her parents that she would be needing insulin and other medicines for the rest of her life. Her father, a lower-middle-class owner of livestock was shocked to find out that only the medicines required for his daughter’s treatment would cost him twenty-one thousand rupees monthly. Recurring laboratory investigations and regular consultation with doctors would add backbreaking burden on his already depleted financial resources.
First, let us ponder on the cardinal reason for the predicament shared above. Without much effort, a universally acknowledged factor often attributed to similar situations is the cost of life-saving drugs. According to World Health Organisation (WHO), equitable access to essential medicines and other medical technologies depends on affordable pricing and effective financing. WHO further emphasises that promoting fair prices and cost-effectiveness interventions are central to the achievement of Universal Health Coverage. Pakistan has its own Drug Pricing Policy that provides key guidelines for drug pricing. However, unfortunately, the recent shortages of frequently used prescribed drugs cast doubt on the role and impact of the policy mechanism. These occurrences are extensively experienced by consumers and often reported in the media.
With hindsight, the solution that can enhance the availability and affordability of life-saving medicine and is also addressed in Pakistan’s drug policy framework is called generic medicine. According to the Food and Drug Administration (FDA) of the US, a generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. In the US, nine out of ten prescriptions filled are for generic drugs. Increasing the availability of generic drugs helps create competition in the marketplace, which helps make treatment more affordable and increases access to healthcare for more patients as per generic drug facts.
Although many stakeholders in Pakistan, including the government, have been advocating the usage of generic medicine, still there are key barriers that need to be understood and addressed.
Lack of awareness among patients about generic and branded medicine is a key factor. Patients’ main concerns are about the efficacy of the generic medicine, availability and costs. This can be easily comprehended by witnessing long queues at places where discounted medicines are being sold. There is a need to create awareness among the masses about alternatives to branded medicines and the availability and cost of generic medicines.
One tragic factor is the tendency of medical storeowners to preferentially sell those medicines manufactured by companies offering higher margins and incentives for sales. Incentives provided by pharmaceutical companies to doctors also demotivate doctors to prescribe generic medicines to patients.
Realistically pharmaceutical companies are mostly profit-driven institutions and answerable to their shareholders. Pharmaceutical companies’ imperative urge to recover research and developmental costs and develop brands for higher sales lead to focusing more and convincing doctors for prescribing branded medicines. At grassroots, the pharmaceutical sales teams are least bothered about who is prescribing and their only concern is about their brand being prescribed.
The key failure of regulatory agencies is the lack of implementation of the policies by the government. The government needs to provide relevant subsidies to the pharmaceutical sector for encouraging mass production of generic medicine. This can be done by providing tax related benefits and reduction in certain import duties on raw materials. Policies conducive to those manufacturers embarking on provision of generic medicine should be designed.
For creating public awareness about generic medicines and the benefits associated with these, it is necessary for the government and regulatory authorities to take certain concrete measures. Information about generic medicine can be made part of the general civic education in schools by the government and regulated bodies. Government approved brochures for creating awareness, need to be made mandatory for placement at medical stores and hospitals. Pharmaceutical companies can be motivated to prominently highlight the generic names of the medicine with the trade name or brand. Professional and regulatory bodies regarding medical profession may enforce rules about writing both the brand name and generic name on prescriptions written by doctors.
One important aspect that strengthens the argument in support of generic medicine pertains to the recent experience of dealing with the Covid pandemic. The WHO during vaccine trials gave Emergency Use Authorisation (EUA) in an epidemic situation. For the greater good, support like subsidies, exemptions and lowering of tariffs need to be provided to manufacturers of generic medicines.
The pricing mechanism is critical, as this is both the spearhead and the steering that drives the motivation of the pharmaceutical industry. The current mechanism of pricing generic medicine as compared to branded medicine needs to be further rationalised to create a true facilitating environment for the growth of the industry.
Stakeholders who are skeptical regarding the efficacy and effectiveness of generic medicine often come up with arguments about first establishing certain quality parameters for manufacturing and prescriptions. All quality manufacturers, generic or branded, use the GMP criteria, a general standard of ensuring quality practices. Therefore, any circular argument that stalls progress needs to be checked in reality, as the people of Pakistan cannot afford to be stuck in any chicken and egg reasoning trap as happened in other reform initiatives.
Overall, the effort should be to support the people of Pakistan so that no other family experiences the mental torture and helplessness suffered by the family of the young Ritu.
Courtesy The Express Tribune, February 10th, 2023.