Medical Device Manufacturers Call for Patient Protection in Manifestoes

After civil society organizations, medical device manufacturers echo the urgent need for better patient protection.

While national political parties are yet to release their manifestoes, civil society groups, traders, manufacturers are putting out their wish lists. The latest group to put out a manifesto for political parties on health is Association of Indian Medical Device Industry (AIMED).

It echoes civil society manifestoes’ demand for patients’ protection, stronger regulation, price capping to make devices and quality treatment accessible.

The key points of their manifesto are:

  • Regulate all medical devices under a patients’ safety medical devices law
  • Protect consumers from predatory pricing through rational price controls
  • Incentivise domestic manufacturing in the medical device sector by introducing nominal yet predictive tariff protection policy. (They claim, this will also shift the sector from import dependency to self-reliance. Currently there is 70% import dependency in the medical device sector. And this sector is worth Rs 30,000 crores)
  • Ensure public procurement of quality medical devices at affordable price, hence call to shift from L1 (lowest cost) to Q1 (best quality at reasonable price). They want a coherent method so best price and best quality can be factored for public procurement in public health institutions

Rajiv Nath, forum coordinator of AIMED, and co-owner of Hindustan Syringes and Medical Devices (HMD) of Dispovan fame, is acutely aware that these are very specific and detailed demands for a political party’s election manifesto. He insists they are necessary for a health-for-all agenda.

Broader wishes like universal health care, free diagnostics, require a thriving medical device sector which is well regulated and produces affordable quality products, explains Dr Jitendar Sharma, chief executive officer and managing director of Andhra Med Tech Zone.

Diluted and fragmented regulation spread across multiple bodies has done more harm to the sector and the patients. Sharma wants that to stop with the new government and a coherent and single regulatory body constituted.

Also Read: #PollVault: Congress Looks to Minimum Healthcare Guarantee, BJP to Modi Biopic

Malini Aisola of All India Drug Action Network (AIDAN), a member of the People’s Health Movement (PHM) coalition, wants regulators to be allowed to do their job, i.e. regulate with a public service commitment and safeguards so their powers should not be diluted. India already has the National Pharmaceutical Pricing Authority (NPPA) and the Central Drug Standards Controlling Organisation (CDSCO) for regulating drugs, implantables and select medical devices.

The government has set a standing committee to provide guidance to the NPPA with the NITI Aayog’s leadership, without any representation of the NPPA. It is the perfect way to undermine the remit and power of the NPPA, she explains. She wants the political parties, when they commit to regulation, should create and strengthen structures that actually regulate with independence and a commitment to public health delivery, she believes.

Congress and BJP’s health promises

Last week, Congress president Rahul Gandhi, in a public address in Chhatisgarh, mentioned his party’s commitment to enact a “Right to Healthcare” and make health a justiciable right, if they came to power. He also spoke about increasing the health allocation to 3% of the gross domestic product (GDP) by 2022 and strengthen the public health infrastructure including increasing number of healthcare personnel. This is not a new declaration. These have been long-standing demands of public health advocates and the UPA-I’s launch of the National Rural Health Mission in 2005 was a response to these demands.

The BJP has already put the Prime Minister’s Jan Arogya Yojana’s (PMJAY) Rs 5 lakh insurance cover for 40% poorest Indians, front and centre, as their commitment to delivering universal health coverage. Many critics feel the scheme strengthens and expands the earlier government’s Rashtriya Swastha Bima Yojana (RSBY) which had a cover of Rs 30,000, without fixing its problems (like over-billing, unnecessary procedures). The current NDA government’s National Health Policy 2017 committed to increase the health sector allocation to 2.5% of GDP by 2025. So the Congress declaration is an improvement.

But the BJP’s PMJAY chant has resulted in one collateral benefit: it has made health part of political discourse and campaign speeches. Richa Chintan, the health nodal of leading think-tank Centre for Budget and Governance Accountability (CBGA), is not very impressed. She feels the focus on insurance has taken the attention away from the state’s withdrawal from healthcare delivery and the increasing role of the private sector. The predatory practices of the private sector, especially large corporate hospitals, is a concern too.

India’s public investment in health sector continues to be one of the lowest in the world, at less than 1.3% of the GDP. 70% of healthcare expenditure is met by private expenses by Indians. And catastrophic expenses in healthcare push 7% Indians into poverty every year. Indians incur 52% of the out-of-pocket-expenditure on drugs and 10% on diagnostics. The PMJAY kicks in only after hospitalisation.

The BJP’s PMJAY chant has resulted in one collateral benefit: it has made health part of political discourse and campaign speeches. Credit: PMO

‘Abandonment’ of PMJAY

PHM, one of the largest civil society coalition for health globally (with a vibrant India chapter), has called for complete abandonment of the PMJAY. Its manifesto reiterates the demand to strengthen the public financing of health sector and public provisioning of health care. Their strident call for abandonment of the PMJAY is based on a globally discredited model of insurance, they claim. That, it is being proposed at the cost of strengthening public health infrastructure, is very concerning, explains Gargeya Telakapalli of PHM.

Other civil society coalitions who have put citizens’ manifestoes are Association of Doctors for Ethical Healthcare (ADEH), Reclaiming the Republic collective and Vikalp Sangam. Reports on salient features of these manifestoes can be found here, here and here.

Also Read: Explained: Why Healthcare Reforms Should Be an Election Issue in 2019

In the election season, advocacy for influencing political parties’ manifestoes goes to a whole new level.

Annie Namala, co-convenor of the Wada Na Todo Abhiyan (WNTA, one of the largest civil society coalitions, committed to Sustainable Development Goals), feels engagement in manifesto should not be an election-time activity only. Manifestoes are commitments and hence citizens and media need to review the government’s performance vis-à-vis the manifesto.

The WNTA did a four-year governance review of the Modi government and they believe the government’s performance on health actually regressed with repeated reduction in public expenditure in health and other social sectors. She hopes, for better or for worse, if the conversation around the PMJAY can bring the 2019 election discourse back to real issues like health, employment and agrarian crisis, it would be a worthy contribution.

Biraj Swain is a senior fellow with the Kalam Institute of Health Technology. She works on international development and human rights in South Asia, East Africa and the UN. She can be reached at biraj_swain@hotmail.com.