The governments of India and the US have released a joint statement affirming the two countries’ commitment to work together in a number of key areas, including intellectual property rights and healthcare-related trade.
Both countries have agreed to “strengthen collaboration, dialogue and co-operation between the regulatory authorities of the two countries to ensure safety, efficacy and quality of pharmaceuticals, including generic medicines” and want to ensure that “the poorest populations in India and the US have access to quality healthcare (while) identifying ways in which trade and innovation policies can enhance access to quality health and affordable medicines”.
India needs systems in place to identify and respond to quality issues throughout the product lifecycle (in this case, generic and other drugs), before these become problems.
Policies and conflicts An examination of endemic problems in the pharmaceutical sector, such as chronic drug shortages and inadequate modernisation in the drug-manufacturing sector, is necessary.
We need not imitate the model adopted in the US, but it would be useful to strategically position in India an Office of Pharmaceutical Quality (call it by any other name if so desired, but revamp our present systems), so that the regulatory authorities are on tap, as well as on top of it all.
The Ministry of Commerce had placed in the public domain (till January 30, 2015), a draft national policy that will revamp India’s IPR policy and “stimulate innovation”.
The Ministry of Health has placed in the public domain its Draft National Health Policy 2015 (till February 28, 2015). Immediate inter-ministerial dialogue must ensure that these two national policies do not work at cross-purposes.
A word of caution is in order here. It is never enough in India for medicines to be merely affordable. These must simultaneously be accessible and available in every block headquarters. If patent monopolies are to drive innovation (as proposed in the draft new policy on IPRs), in that event, drugs and medicines will remain neither affordable nor accessible!
It is for the Ministry of Health and Family Welfare to remain vigilant about its own goals and resolve these contradictions.
The India-US Joint Statement states that the Healthcare Dialogue is slated to cover “affordable healthcare, cost saving mechanisms, distribution barriers, patent quality, health services, information technology and complementary and traditional medicine”.
The world over, current health care systems are being overtaken by rapid technology transformation, data-driven diagnosis, new discoveries in medicine, a healthier population, and a focus on chronic conditions.
Healthcare in India is under-served and over-consumed. India did not invest in an integrated public health system involving food safety, water management, waste disposal, vector control, sanitation systems, health education and health regulation. Quality of care is compromised on account of limited accreditation, and low adoption of basic technologies.
Affordable healthcare The Healthcare Dialogue between both countries would enable India to make that great leap forward to move beyond the manufacture of generic drugs and emerge as an innovation hub in lower cost health products and services.
It can also help boost local manufacturing, and transform India into an export hub for medical products and equipment, and facilitate — and develop within India — an R&D hub for tropical diseases.
The fact remains that at primary healthcare levels, general practitioners are the only ones who can provide patient-oriented holistic care. The introduction of a market-based incentive for general practitioners would restore to them some pride of place in public health policy and programme, and would help deliver on access, availability, affordability and quality of healthcare, at household levels.
The India-US dialogue will also help scale up and expand healthcare packages to integrate screening, prevention, treatment and follow-up, across the delivery, insurance, technology and pharmaceutical sectors of the healthcare industry, through appropriately developed public-private partnerships.
It will also push India to remain vigilant about enforcing its patent laws.
The writer is Senior Advisor, Outline India. She is a former Special Secretary, Ministry of Health.