India Must Tackle Patents, Trademarks Head-on For Affordable, Accessible Drugs

The COVID-19 pandemic has reinforced the view that adopting a patient-centric approach is the future of the pharmaceutical industry, and with digitization pervading the industry at a fast pace, it will be quicker than imagined. 

Since patient centricity demands putting the patient at the centre of drug development and treatment, access to medicines and their affordability are key factors of the concept. Access to essential medicines is a vital element of universal health coverage (UHC), a specific target of the UN’s sustainable development goals (SDGs).

While urban India has better access to healthcare and medicines, rural India often struggles with even the most basic healthcare intervention, including medicines. Almost 65 per cent of India’s population that resides in rural areas has access to only 30 per cent of the total available health infrastructure.  

There is a need to continuously upgrade processes which can lead to a cost-efficient and effective system of procurement of medicines for public hospitals, along with the establishment of in-house drug retailers in public hospitals to improve access to medicines by ensuring availability, affordability and physical accessibility to essential drugs.

While the affordability of medicines in the country has received policy focus, the availability of medicines for patients, particularly in unreached areas remains a matter of concern. A healthcare centre or pharmacy is often far away from the place of residence or work for patients living in hilly terrains and rural areas. 

This can lead to patients often tending to delay routine check-ups, avoiding treatment or non-adherence to taking medicines, resulting in the late detection of health conditions or no treatment in the early stages of a disease. The rising incidence of NCDs among both urban and rural populace is also shaping up as another formidable challenge for the healthcare system.

The size of the rural market presents a huge opportunity for solution providers to expand because this segment will be the industry’s growth driver in the coming years. One way of addressing the access issue could be the deployment of mobile medical vans. 

There is also the need to improve the pharmacist-to-patient ratio across India which stands at 1:4000, much below the WHO’s recommended level. In order to improve accessibility, more pharmacies must be established and sufficiently staffed with trained pharmacists.

Making medicines affordable

India is one of the five countries with the lowest prices for branded and generic drugs and has an elaborate price control mechanism for essential medicines. The government is advocating the wider use of plain generic drugs to make medicines more affordable. 

But healthcare should not be seen only through the lens of branded drugs and cheaper generics. Instead, the focus must be on the quality of medicines which ensure that patients are cured under the Standard Treatment Guidelines (STG).  

Branded drugs represent confidence because they are produced by companies whose quality is trusted by doctors. There is a quality control system and good manufacturing prices in place. The key aspect here is that drugs need to be safe, effective and provide best outcomes for patients.

Addressing patent issues can also help in making medicines accessible and affordable. In March this year, India rejected Johnson & Johnson’s application to extend its monopoly on the key tuberculosis drug, bedaquiline. 

This landmark decision frees India from depending on one company for a drug that is vital in the fight to eradicate TB. It has paved the way for generic versions at half the price making it more affordable and accessible for patients.

India must tackle IPR issues head-on

The intellectual property rights of global pharma majors can pose a threat to the pharma industry’s patient-centric approach. A substantial number of Indians live in poverty which is why the country puts a premium on public health vis-à-vis pharmaceutical patent law decisions. 

In most cases, pharmaceutical patents restrict the generic competition and consequently increase prices and are a formidable barrier to access to medicines in developing countries. Various studies have pointed out that extending patent rights extracts a significant cost from a country’s economy.

India is WTO TRIPS compliant and if India carries out any policy changes that weaken generic competition, it will not only affect health expenditure of people in poor countries but also in developed countries like the US, the UK, and European countries that rely heavily on the import of cheaper Indian medicines. 

While access to affordable medicines is a global problem, other countries can learn from India’s patent policy which has been crucial for access to affordable medicines not only for Indians but for many other countries as well.

India must remain alert against any attempt to push in data exclusivity which will delay the entry of affordable generics for a significant number of new drugs and some medicines may not even be introduced. 

Under the TRIPS Agreement India has no obligation to introduce this provision. India’s patent law has a provision to stop ‘evergreening’ of patents. India must also guard against the extension of the patent term for the pharma sector which is a TRIPS Plus provision and will delay the entry of generic medicines into the market, depriving patients of affordable medicines. India does not provide for patent term extension and has no obligation under the TRIPS Agreement to introduce it.

India has played a pivotal role in critical medical fields such as oncology and diabetes, as well as achieved a notable milestone which is 100 per cent eradication of polio. We supply every 3rd tablet consumed in the United States and every 4th tablet consumed in the European Union. 

Further, Indian medicines have made a substantial impact in treating HIV/AIDS, with 37 per cent of patients benefiting from medicines made in India. Having come this far, as a country, we must ensure that unfair demands around trade agreements and patents do not become barriers to accessibility and affordability of medications. 

Mercy Annapoorani

Guest Author Executive Director and Managing Trustee, Blossom Trust India