When we talk of affordable medicines, a major issue raised by pharmaceutical companies is about their investments in R&D. We need more effective medicines, new medicines for which R&D is essential. So, how to strike a balance between research expenses and affordability?

Access to quality and affordable medicines is important. Goal number 3 of the United Nations Sustainable Development Goals (SDG), which are to be achieved by 2030, is ‘good health and well-being’.  It cannot be separated from ensuring access to safe, effective, quality and affordable essential medicines and vaccines for all. It is also the core of FIP Vision. About 2 billion people in the world have no access to medicine. The problem is that new medicines are expensive because the industry is fixing high prices for them. But, there are ways to deal with this problem. Take the example of COVID-19 vaccine. mRNA types of vaccines produced by Pfizer and Moderna, based on new technologies, are more expensive than traditional ones. Hence, you have a few countries like not only India, but in Africa and East Europe which also can't afford it. These countries will stay with traditional vaccines.

Take another example like oncology and immunotherapy. They are expensive. Or take cases of rare diseases where the drugs have to influence genes and an injection course may cost $1 million. Who can pay for that? You are right, they are very expensive and one of the reasons is that the research is more expensive. The second reason is that the industry is discussing the value and not the price of a medicine. Still, I feel that access to quality medicine and also to innovation should be developed. All pharmacists, pharmaceutical scientists and educators have a key role in this and in the evolution of the profession around the world. The governments, industry and health workers in respective countries should discuss what can be done to keep a balance between the price and justifiable benefits for the industry but also the right of patients to have the right medicine.

There is one more aspect related to healthcare in India. Here, pharmacists should be allowed to treat minor ailments like it is being allowed in several developed countries. Pharmacists in Switzerland are allowed by law to treat around 20 ailments. This reduces the load on the healthcare system (General Practitioners and Emergencies in the Hospitals). Pharmacists have a huge potential which needs to be recognised and used properly. 

FIP is working on antimicrobial resistance (AMR). How do you see that as a problem in the world and what can be done to escape from that?

It will be a big issue worldwide. If something is happening with bacteria and we don't have any antibiotics for that, then we'll have thousands and thousands of deaths. What we have to do is to combat the resistance with the appropriate use of antibiotics and also to activate the research for new antibiotics even if it is not so lucrative for the industry. Even pharmacists can play a role in this. Dr Puneet Gupta, Chief Coordinator – Drug Discovery and Development Cluster, Amity University, gave an interesting presentation on this topic at the IPC. In FIP we have a booklet to guide pharmacists on the role they could play. Our Vice President Manjiri Gharat is one of the leaders in resistance and working on it. It's important that pharmacists are trained to give advice to the doctors, and to the patients on how to take the antibiotics. It is also important to communicate to the doctors not to prescribe too many antibiotics. Not to prescribe antibiotics if they are not needed. You can pledge to become an 'antibiotic guardian' as Dr Mahendra G Patel, Professor, University of Oxford, UK, suggested in his presentation at IPC. Just go under and follow the instructions https://antibioticguardian.com

What‘s your perception about the Indian pharma industry and where do you see it five or ten years from now? 

One of the issues is that India should invest in the research to develop innovative medicine and not only produce generics, because generics is one aspect of the economy you can do with medicine. If research and production are less expensive in some countries, the drug prices should be more affordable for patients and for health systems. So, I believe, all over the world in this new strategy, each country or each region is developing research, compounding of products for itself and not just import or export of medicines. Because the production has been mostly transferred to countries where it is less expensive to produce medicines, we see now the problem of shortages during and after the pandemic. A lot of products are no longer available in the market like paracetamol for children, some oncology products, anaesthetics, antibiotics, painkillers like Ibuprofen or morphine derivative.  Not just India, but also Europe is in a predicament. We don't have the products due to compounding problems or sometimes packaging is missing (no plastic for syringes for example). Also, APIs were no more affordable or accessible because the industry was closed in India or in China.

Yes, India faced the problem of shortage of Active Pharma Ingredients (APIs) due to pandemic in China. Indian industry learnt its lesson and started producing APIs indigenously. Do you think the same strategy will work for shifting India from generics to innovative medicines?

Yes, I think so. Because I'm sure that India now has the know-how in compounding and it has very good scientists. But a lot are not in India. They are in the US, Canada or UK. When they will come back to India, maybe it will be good for the country. This is my personal view. We too have the same problem in Switzerland regarding human resources like nurses, doctors and pharmacists, trying to attract human resources from other countries. This cannot be a sustainable strategy! And it is unfair towards the countries who spend the money to educate these specialists!

Just recently there have been some incidents wherein Indian medicines were banned by some countries due to the quality issue. How do you look at this problem? How to overcome it? What can be done? 

I think the quality of the compounding is mandatory. We can't play with the health of the people.  Because of the lack of quality in compounding some people face dangers. I can understand a country no longer giving authorisation to some companies because their products lack adequate quality. But nowadays you have a quality management system with good practices in compounding and dispensing. With that it is possible to enhance the quality, control the quality. We talked about the need for some Indian companies to research and produce innovative drugs. Quality is important. Quality is an important aspect in every domain. 

But to overcome this problem what needs to be done?

I don't know the reasons. I can't imagine that the people who are dealing with compounding don't know that we need a high quality. They know that. But maybe it's too expensive to produce with quality and they try to bypass the quality procedures to make more profit. But it has some consequences. The only possibility is to increase the quality control by the government to assure the required quality.

What exactly is FIP doing in India and elsewhere also? What kind of cooperation is there between FIP and Indian industry?

We are supporting the work of the member associations in different countries. We have 127 member organisations representing three million practitioners and scientists around the world. For me it's very important not to force a country’s association to implement some services for pharmacists or some projects. We decided to ask every region what their needs are for the next three years. And they decided on them because a national organisation is the best one to know what the health system in that country needs or what the population needs or is locally organised. They have to decide on their priorities and then tell us and then we create some project to support them.

We made 21 FIP development goals for pharmacy and with that we give guidance on how the profession should grow and evolve. And this is quite a particularity for sciences, for education and for practice. 

One more issue is that the coordination among pharmacy education and workforce, practice, and science is lacking everywhere. Actually, these three forces can work under one roof. For example, in India, pharmacy education is looked after by pharmacy councils and universities. If changes introduced by the council do not reflect at university level in a time bound manner then there is a problem. Considering all these aspects at FIP, we are planning to prepare a strategy to reduce the existing gaps in pharmaceutical science, its practice and education in different regions.

High-level preparedness to meet the challenges like pandemic, which we witnessed during COVID-19, should be a permanent part of our health system. FIP is working on this issue also.   

Dr Milind Kokje 

milind.kokje@mmactiv.com