In recent years, the Indian government has shifted its focus from the local manufacturing of life-saving drugs at a low cost to facilitate multinationals sell patented medications at higher prices. The primacy given to voluntary licensing over compulsory licensing in India’s recently signed free trade agreement (FTA) with the UK marks the continuation of a move that began much earlier.

In bustling markets of Mumbai, patients stand in long queues outside pharmacies, clutching prescriptions for life-saving medications. Among the throngs is Priya, a single mother of two, whose heart races as she learns the price of her cancer medication has skyrocketed, leaving her to choose between affordability and her family’s wellbeing. Underpinning this reality is a significant shift in India’s pharmaceutical landscape, reflected in its recent FTA with the UK, prioritizing voluntary licensing over compulsory licensing for generic drugs.

Commerce Ministry’s stance

The Ministry of Commerce and Industry vehemently denies that this new agreement dilutes India’s rights to issue compulsory licenses. Officials assert that the FTA simply recognizes global best practices, promoting collaborative solutions rather than limiting access assured under the Patents Act of 1970.

• The government claims it has not permitted patent extensions or data exclusivity—two mechanisms that facilitate “evergreening” of patents.
• The focus on voluntary mechanisms, they argue, does not infringe upon existing laws designed to protect public health.

Where it falls short

However, these assurances ring hollow to many advocates for public health. Critics argue the FTA’s language lacks explicit references to compulsory licensing, raising concerns over the implications for generic drug manufacturers. Furthermore, it carries forward certain provisions that dilute procedural safeguards, including:

• Granting patent controllers unprecedented powers to decide the validity of challenges against patent applications.
• Imposing fees for such challenges, making it financially burdensome for small players.
• Extending the disclosure timeline for patent workings to every three years, shrouding violations under the 1970 Act in secrecy.
• Shifting the onus of providing patent information to controllers, creating obstacles for transparency.

These changes not only allow patents to go unchallenged but also blur the lines of accountability that were initially established to protect public access to medicines.

What are these licences?

The Patents Act of 1970 is clear—it provides a framework for compulsory licenses to be granted to generic manufacturers, enabling them to produce affordable versions of patented drugs without the consent of patent owners. This arrangement facilitates access to critical medication under specific conditions, addressing the balance between intellectual property and public health.

In contrast, voluntary licensing is a commercial agreement that encumbers generic manufacturers with various conditions, undermining the intended accessibility. These contracts frequently entail:

• High royalties that inflate final drug prices.
• A lack of transparency in terms of contractual obligations and drug availability.
• Geographic restrictions that may limit distribution even in dire need areas.

When compulsory licence came in

The landscape changed dramatically in 2012 when India issued its first compulsory license to Natco Pharma, allowing them to produce a generic version of Bayer’s Nexavar, dramatically reducing the price from ₹2.84 lakh per month to ₹8,800—a landmark moment for public health advocacy. Government officials rallied behind Natco’s efforts, highlighting a collaborative spirit that has since dwindled in recent years due to growing pressures from international pharmaceutical lobbies.

How India backtracked

Signs of a significant policy shift appeared as early as 2016, with the US-India Business Council reporting that Indian officials had “privately assured” the US they would refrain from issuing compulsory licenses for commercial purposes. Such news triggered waves of concern among health activists, foreshadowing the current landscape where practical access to affordable medicines is at risk.

The USTR that followed quickly flagged India on its “priority watch” list, expressing concern over India’s inclination toward local pharmaceutical makers and the ramifications for global drug pricing. Despite ongoing international scrutiny, Indian advocates mounted formidable resistance against pressures to abandon public health mandates.

Pandemic event

The COVID-19 pandemic proved to be a critical juncture. In 2021, India’s government faced scrutiny when it refused to allow the manufacturing of generic versions of essential COVID-19 medications, claiming it was against the backdrop of a global health crisis. This marked a significant departure from the principles established during earlier periods, emphasizing diplomacy over public health policy.

Patients in protest

The fight for compulsory licensing continues, spurred by desperate patients. Health activist KM Gopakumar notes that courts are being approached with petitions for compulsory licenses for exorbitantly priced medications such as:

• Ribociclib (₹64,000/month)
• Abemaciclib (₹48,000-95,000/month)
• Risdiplam (₹6.2 lakh/bottle, ₹18.6 lakh/three bottles for adults)
• Trikafta ($320,000/year)

Gopakumar critiques the government’s dismissal of compulsory licensing claims, noting that while it argues that alternative treatments are available, the critical gaps in care remain unaddressed.

Voluntary licences not the answer

A study by Médecins Sans Frontières in 2022 underscored that voluntary licensing cannot be relied upon to serve public health needs adequately. The data revealed that governments must act through compulsory licenses to ensure equitable access to affordable medications. Given India’s historical precedent of successful compulsory licensing, the narrative must pivot back towards patient rights and accessibility.

The onus now rests squarely upon the Indian government—to recalibrate its stance on compulsory licensing amidst rising healthcare costs and growing global scrutiny. For families like Priya’s, the stakes are immeasurably high. As the chorus for affordable healthcare grows ever louder, the urgency to reclaim the country’s commitment to public welfare remains critical.

Source: thefederal.com