We do whatever we can to ensure safe use and administration of products
Dr Claus Runge, Global Head, Market Access, Public Affairs and Sustainability, Pharmaceuticals Division, Bayer AG, and Viveka Roychowdhury, discuss how the company plans to expand access to its products in low-middle income countries like India, while ensuring the products meet safety standards, and are used in the proper manner
How safe and proven are the modern contraception systems in India’s population given the low literacy levels, lack of doctors in case of adverse events?
We are operating in a highly regulated environment. The products that we are developing are being developed under the highest standards, and according to good clinical practice, we are in very close interaction with the regulatory agencies worldwide to make sure that the benefit-risk ratio of our products is appropriate for them to be administered or offered to physicians. So, the products we offer are very safe.
On the questions on the employment of those and the use of those, we do have the product information that comes with them. So, we do have the information in summary of product characteristics (SmPC) and leaflets, and, of course, we are offering educational services to both physicians and the patients (if needed)/partners in the various geographies we work in. We do whatever we can to ensure the safe use and administration of the products.
As the last component, first is the development and the dialogue from the regulators, and second is for the providers and patients we grant or offer information. Thirdly, we have pharma co-vigilance systems in place worldwide where we are constantly following up on with whether the products are safe and properly used.
How affordable are they, and therefore, how accessible?
When it comes to affordability, we do have a global pricing philosophy that follows the idea of pricing according to national income levels. So, for our entire portfolio, we have introduced the tier-pricing system, for crop products and also for future new launches, which means that the product pricing should be taken into consideration in accordance with the country’s patient’s affordability and its product value.
We have three tiers worldwide, according to the World Bank classification of countries, and we distinguish the prices among those three bands. This has helped us with improving the affordability in many low-income countries and we have a range of examples where we have made significant progress in a range of examples of countries where we have more patients who are being provided with access to our products.
What’s the innovation that makes Bayer’s products better than the existing products?
There’s a range of products in our portfolio that offer significant benefits to patients.
If you look at the cardiovascular and cardiorenal portfolio, we have products like Xarelto (Rivaroxaban), among the top-selling products worldwide, given in a couple of cardiovascular and thrombotic indications. This is one of the gold standards in treating patients for cardiologists.
We do have a couple of new products that are being developed in the cardiorenal space, for example a product that is about to be launched in India- Vericiguat with the brand name Verquvo. The
product is indicated in treating patients with worsening heart failure. That is the area with significance in treating the unmet needs of the patients, as to my understanding, cardiovascular diseases are killers in India. So, there is a high patient number that can be addressed with these products, especially in heart failure. There aren’t many options in place in the armament for physicians, at the moment.
Another product launch would be of the product/Finerenone and the brand name would be Kerendia which is used to treat adult patients with chronic kidney disease associated with type-II diabetes. It is also an important product if you look into the number of diabetic patients that are skyrocketing in many industrial/developing nations.
These are the true game-changing opportunities or products that physicians will have in hand, also, in India. For both, we’ll see that in India, we’ll have launches that’ll closely follow the timelines of the first launches in the, for the lack of a better word, Western Hemisphere (the US and parts of Europe). We have been working closely with Indian regulators to make Finerenone available for Indian patients within a short period after the launch in key regulated markets (e.g. USA). Bayer India is participating in global clinical studies with Finerenone contributing to global development. That shows our willingness to broaden the patient expertise across the globe significantly.
So, in renal, we have late-stage developments in the area of cardiovascular disease and anti-thrombotic agents, just to name a few. We also have a product that is being developed and will soon be in phase-III, for menopause syndrome.
Further, into the future, Bayer has made significant investments in the cell and gene therapy platforms. We have acquired a couple of companies that have the latest technology in this segment.
This is something where we’ll see a true leap in the way some diseases may be treated in the future. While some may talk about bio revolution, where you have a cell and gene therapy which will potentially be able to even heal some of the diseases for which we don’t have any treatment today.
Cardiorenal is a stronghold for us along with women’s healthcare, of course; and, thirdly, cell and gene therapy where we will see significant progress in the coming decade. With the acquisitions that we have done, we feel that Bayer is ideally positioned to be amongst the leaders in this field.
As per the United Nations Sustainable Development Goal and the mission- ‘Health for all, Hunger for none’ and as a leader in women’s health by 2030, Bayer aims to apply the same global initiative of giving to over a hundred million women the access to contraception. How many women in India are going to be a part of this initiative?
We have defined an ambitious ESG agenda as a company. The environmental component is, of course, one important part of it. We have set ourselves ambitious decarbonisation goals. And, as you rightfully say, within the pharmaceuticals division, there are two components that we want to increase.
On one hand is the access to medicine in terms of our overall portfolio and then we have different ways of pricing our products keeping in mind more and more patients in low-and middle-income countries. The second one is the one hundred million challenge that we have defined for ourselves. It means that we want to make sure that hundred million women worldwide would get access to modern contraceptive options. The current worldwide gap is in the ballpark of 250 million women who lack access to these contraceptive choices.
We have a range of activities in the field which entail increasing in the supply of these products worldwide in low and middle-income countries. We have built an extra factory which we built in a record time in Costa Rica that will produce long-acting contraceptives for low-middle income countries. So, that’s going to be one of the core components on the supply side so that we can live up to the promise.
Second is partnerships. We have a strong bond with the United Nations Population Fund, and we’ll be meeting their respective representatives in India to discuss joint activities. We have a partnership with John Hopkins University which runs the so-called challenge initiatives, including activities here in India, where sexual and productive services are being offered to the people living in the ever-growing informal settlements in the low- middle income countries, including in India. We want to bring these services to the most vulnerable ones and to the ones who need it the most.
Thirdly, we are committed to humanitarian aid where we help in the context of civil wars, for example, where we collaborate with the International Red Cross and the Red Crescent Movement to help with logistics and to help with contraceptives in that setting.
Coming back to the question of quantities, given the size of the population in India and its growth, India represents a significant part of women who would love to gain access to modern contraception and who don’t get it yet. In the middle of making sure that above and beyond our supranational activities with the USAID and UNFPA and alongside our commercial activities in this field, we’ll expand the partnership ecosystem in India and will drive the numbers so that India represents a significant chunk of the 100 million-challenge. The number which we project for 2030 in terms of the contribution for India is around five million who will have access to modern methods of contraception. That’s what we are aiming for.