– By Bhavesh Shah

As the Director of International Marketing for Hetero, with nearly 30 years of experience and specialisation in HIV, Bhavesh has been instrumental in licensing with multinational pharma.

Bhavesh has a wealth of global experience and played a significant role in business policy and strategy for Global Access markets as well as product segmentation for HIV. He is also responsible for managing relations with external stakeholders such as the Medicines Patent Pool (MPP), the World Health Organization (WHO), the Joint United Nations Programme on HIV/AIDS (UNAIDS), the United States President’s Emergency Plan For AIDS Relief (PEPFAR), UNICEF, the United Nations Development Programme (UNDP), other UN organisations, global and regional NGOs & country partners.

 Voluntary licensing: improving access to essential medicines

Over the years, Hetero has established its strong leadership in antiretroviral (ARVs) and antiviral therapies and caters to 40% of existing global demand for ARV APIs and Finished Dosage Forms (FDFs) used in HIV treatments. Voluntary licensing has enabled us to expand the access of critical medicines to the larger population without infringing any intellectual property rights.

Hetero has been working with MPP for almost a decade now, we signed our first sublicence in 2012. What we at Hetero find most useful is the support we receive from MPP’s Indian office, this can on the industry landscape reports with the market share and regulatory approvals of licensed products or providing clarity on the patent situation in different markets. This sharing of scientific and commercial updates gives us a better understanding of the market and our positioning. The MPP team also helps resolve technical issues which may arise in product development and filing with regulatory authorities.

What appeals to us in MPP licences is that it ensures a level playing field for all the sublicensees with the terms and conditions, territory, and timelines common to all. The sublicences also ensure that the product is developed in compliance with all regulatory requirements for approval by the Stringent Regulatory Authorities (SRAs), allowing all products to be available and supplied with the highest quality standards.

Adapting to the COVID-19 pandemic

We are two years into the pandemic and thanks to our agility we have innovated along the way to maintain our activities and show results. The lockdowns resulted in many challenges ranging from availability of raw materials and manpower to logistical issues impacting the supply chains. Despite these challenges, we remained committed to our suppliers delivering the goods on or before time to ensure that patients are not out of stock for the life-saving medicines. This is of particular importance to people living with HIV, having multi-month dispensing packs have also been very helpful in COVID-19 times as HIV positive clients don’t need to visit the healthcare facilities frequently.

We too at Hetero are keen to help all those affected by COVID-19. Earlier this year we signed a sublicence agreement with MPP to manufacture the generic version of Pfizer’s oral COVID-19 treatment nirmatrelvir and contribute towards reducing the health burden due to the pandemic. We hope that having several generic versions of the product will be of benefit to patients.

HIV and hepatitis C treatments

We are committed and remain invested in the field of HIV care. With a presence in this field for over two decades, our HIV business is at the core of our corporate business strategy. Dolutegravir (DTG) based regimens are the preferred option as per WHO guideline for both first-line as well as second-line HIV treatment. With the support of MPP our licence on DTG has expanded our market and helped us in implementing and fulfilling our HIV strategy. Last year, we signed a sublicence to provide DTG in four upper middle-income countries (UMICs), which helps us to further extend the access to namely Azerbaijan, Belarus, Kazakhstan and Malaysia.  In the fight against HIV it is vital that no one is left behind just because of where they live.

Hepatitis C remains a global concern, the sublicence agreement for the hepatitis C treatment daclatasvir (DAC) has allowed us to make the product available within the licensed territory. We are hopeful that uptake will increase in the future for this very much needed treatment.

Looking ahead

Following MPP’s mandate expansion into essential medicines, non-communicable diseases (NCDs),  and more recently COVID-19 products and technologies, we are very much looking forward to MPP licensing more products where IP hinders access in LMICs. We have a robust portfolio of developing these products and would be happy to partner with MPP in saving lives and improving access.

Overview of Hetero sublicences with MPP: