Controversy Around HPV Vaccination

Source: The post controversy around HPV vaccination has been created, based on the article “Indigenous HPV vaccine, the rhetoric and the reality” Published in “The Hindu” on 9th July 2024

UPSC Syllabus Topic: GS Paper2-governance- Issues relating to development and management of Social Sector/Services relating to Health.

Context: The article discusses the promotion, timing, and high cost of India’s HPV vaccine, Cervavac. It questions the need for universal vaccination against HPV, highlights delay in development due to patent issues, and criticizes the high price despite potential for lower costs.

For detailed information on Status of cervical cancer in India – free future read this article here

What is the HPV Vaccine?

1. The HPV vaccine is designed to prevent cervical cancer by targeting the human papillomavirus (HPV).
2. Only a few out of over 200 HPV strains are linked to cervical cancer, specifically causing precancerous lesions.
3. Despite the vaccine’s aim, most individuals with HPV do not develop cancer; infection is common, but progression to cancer is rare.
4. India’s Serum Institute developed Cervavac, an indigenous HPV vaccine, using recombinant DNA (rDNA) technology, similar to early vaccines like the Hepatitis-B vaccine. The vaccine targets pre-puberty girls, based on the assumption that preventing HPV transmission at a young age will reduce cancer rates later.

How Have Patents Affected Vaccine Development?

1. Patents have shifted vaccine development from public to private sectors, changing the landscape of innovation.
2. The U.S. Patent Act amendments in the 1980s allowed for the patenting of genetically modified organisms and life processes, facilitating private monopolization of vaccine development.
3. The TRIPS agreement globalized U.S. patent laws, impacting vaccine production and distribution worldwide.
4. This resulted in delayed availability of vaccines like India’s Cervavac, which had to wait for key HPV vaccine patents to expire before development could begin.
5. Patented vaccines such as Gardasil and Cervarix were developed under these new conditions, setting precedents in vaccine commercialization.

What Impact Has This Had on India’s Vaccine Industry?

1. India’s 1970 Patent Act fostered the growth of its domestic vaccine industry by allowing only process patents, not product patents.
2. This enabled rapid development and production of generic drugs and vaccines, positioning India as a global pharmacy.
3. The introduction of product patents under TRIPS slowed down the development of new vaccines like Cervavac, which took two decades after similar vaccines were available globally.
4. Despite infrastructure capable of producing at scale, Cervavac’s market pricing remains high, raising concerns about the application of patent laws and their impact on affordability and accessibility in India’s vaccine market.

What is the Controversy Around HPV Vaccination in India?

1. Association with Cancer: The link between HPV and cervical cancer is controversial. While certain strains of HPV are associated with precancerous lesions, most HPV carriers do not develop cervical cancer.
2. Moral and Cultural Concerns: The push to vaccinate pre-puberty girls based on assumptions about their future sexual behavior is seen as problematic. This perspective is viewed as imposing Western values and may be considered a moral issue within the conservative fabric of Indian society.
3. Gender Bias: The focus on vaccinating girls and not boys highlight a gender bias, overlooking the fact that men can also be carriers of HPV.
4. Cost Issues: The high cost of the HPV vaccine poses a significant barrier. The government price is ₹500 for two doses, but for those not covered by government programs (recommends Cervavac for girls aged nine to 26), the retail price escalates to ₹2,000, making it unaffordable for many.

Question for practice:

Discuss the various challenges and controversies surrounding the implementation of the HPV vaccine Cervavac in India.