A Step Closer to Making Medical Devices More Accessible

Developing global standards on essential devices and ensuring their adherence is still some way off.

The theme of the 4th World Health Organisation (WHO) Global Forum on Medical Devices (GFMD) was “increasing access to medical devices”. Why should access to devices matter? Because as of 2008, in the 60th World Health Assembly, a resolution was passed recognising the importance of medical devices for healthcare delivery, responding to emergencies and keeping populations safe.

Yet, as of 2018, the selection, regulation and use of medical devices continues to pose enormous challenges. Especially since there are no standard specifications applicable across the world, as also exposed by the International Consortium of Investigative Journalists’ (ICIJ) global expose’ Implants Files.

The 4th Global Forum on Medical Devices was dedicated to precisely this – the roadmap to develop standards, regulatory framework and increase access. Organised in Vishakhapatnam, at the Andhra Med Tech Zone (AMTZ), from December 13 to 15, it was attended by 100 countries and curated by the WHO’s Essential Medicines and Health Products division, which leads this work globally. 

Below are some highlights from the forum.

Preparing to deliver essential diagnostics

Following the declaration of the WHO’s Essential Drugs List in 1978, the Essential Diagnostics List was declared in 2018 at the 71st World Health Assembly in May. The focus in multiple panel discussions was to listen from various health ministries and the medical devices’ sector on their preparedness to deliver essential diagnostics to all.

The government of India presented its Free Diagnostics Initiative. Dr S.P. Sinha of the National Health Systems Resource Centre shared the tiered approach to provision for diagnostics tests. As per the National Health Mission’s mandate, Sub-Health Centres have 6 tests available, Primary Health Centres have 19 tests, Community Health Centres have 39 and district hospitals and above have more than 50 tests available.

Also read: To Tackle the Tuberculosis Crisis, Diagnostics Must Be Brought Closer to Patients

They also plan to conduct quarterly audits to check if some tests are being unnecessarily or over-prescribed. While most low-and-middle-income-countries (LMICs) took a tiered approach, South East Asian countries shared a more universal approach, trying to make all tests available to patients at all tiers of healthcare.

This is considered a flagship intervention to reduce the out-of-pocket expenditure burden on the patients. Yet the diagnostics’ load, long delays in public health centres and exponential growth of the private sector in diagnostics, received scant attention.

Setting technical specifications

This was a major ask from country governments and the device manufacturing sector. In addition to oxygen supply in public health institutions, WHO also expects to develop global guidelines and specifications for cancer treatment (oncology and radiology), equipment maintenance and delivering essential diagnostics.

India is also lobbying to come out with a comprehensive classification list for all medical devices standardised across the world so that devices and processes can be regulated transparently. But WHO’s nodal division appeared to be at disparate stages of progress with guidelines. On oxygen supply much work has been done, but on classifications and regulations it is yet to begin.

Medical device donation and ethics

This was a key plenary topic and the panel opened with a solid presentation that most device donations are second-hand, repeat use devices and some serious ethical concerns. But there was no conclusion or resolution emerging from GFMD. Recently, Pfizer’s pneumonia vaccines’ donation was rejected by Médecins Sans Frontières (MSF); they cited that such donations distract from real conversations about price regulation and access to global public goods.

The latest expose’ by the ICIJ, Implants Files, also highlights condemned/banned and second-hand devices finding their way into LMICs. With such developments, panels on medical device donation closing inconclusively was disappointing.

Absence of adequate NGOs/Civil Society coalitions

People’s Health Assembly (Jan Swasthya Abhiyaan in India) and the All India Drug Action Network (AIDAN) were absent.  Their presence in Geneva at the World Health Assembly is significant. Their presence in the GFMD would have enriched the conversations and brought in the much-needed patients’ rights and ethics perspective.

Complete silence on knowledge transfer and technology transfer

The Sustainable Development Goals (SDGs) talk of setting up a global architecture and forging partnerships across countries so that the knowledge asymmetry – and consequent inaccessibility and inequity – between the developing and developed nations and big-pharma, headquartered in the global north, can be challenged and unfair trade practices and profiteering stemmed.

When it comes to the SDGs, the UN institutions, including the WHO are the leaders. Hence having a whole conference dedicated to medical devices, yet have no panel focussing on how to address the contentious issue of knowledge transfer, was remiss in more ways than one.

A few words on the Andhra Med Tech Zone

AMTZ was the venue and the government of India and government of Andhra Pradesh were co-hosts along with the WHO. Why AMTZ? Because it is the first medical technology zone in the developing world. It is mandated to make India self-sufficient in the medical devices sector and support LMICs by investing in affordable devices.

The Indian medical device industry is the fourth largest in Asia after Japan, China and South Korea. The sector size is Rs 30,000 crores and is poised to double by 2030. However, currently India is dependent on imports for 90% of its devices. Addressing this import dependency is the main objective.

Also read: The Desperate Global Need for Medical Diagnostics

A key feature of AMTZ is its 18 complex labs in one location. Any device needs to run through almost 18 complex labs before it can be applied in the real world and AMTZ has all the of them in the same address to foster innovation, clinical trials and manufacturing.

Dr Jitendar Sharma, CEO and managing director, AMTZ is also convening a global task force to design a health cadre akin to MSF. This will be the International Bio-Medical Engineers’ Corps which will volunteer across the world, especially in emergencies and low-resource settings.

How soon the global standards, specifications and regulations are developed and adopted for essential medical devices, will determine the success of the 4th GFMD. Civil society and patients’ rights advocates have their work cut out, in monitoring access to medical devices and influencing ProPublica regulations and their adherence.

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