The world’s largest association of medical device companies, Advanced Medical Technology Association (AdvaMed), is learnt to have conveyed to two senior Trump administration officials that the NDA government’s flagship ‘Make in India’ platform has been used to “justify protectionist measures” — and has “not encouraged US medical technology firms to increase their presence in India”.
The Indian Express has learnt that AdvaMed, in its briefing memo for Commerce Secretary Wilbur Ross and US Trade Representative Robert Lighthizer last year, conveyed that the scheme has been “used by parts of the (Indian) government to justify protectionist measures such as import tariff hikes and preferential market access policies”.
According to the memo, AdvaMed stated that “in addition to price controls as a barrier, the regulatory environment in India continues to be opaque and unpredictable”.
In order to make medical devices affordable, India had imposed price caps on coronary stents and knee implants in February and August 2017. AdvaMed has strongly opposed these caps stating that it has the “potential to block innovations and limit access to world-class medical care and options to deserving patients”.
Washington DC-based AdvaMed, which represents US pharma and tech majors such as Abbott, Boston Scientific Corporation, Medtronic, BD, Pfizer, Apple and Microsoft, is not the only industry group that has complained about India’s “protectionist” measures. US President Donald Trump has referred to the duty on import of completely built American bikes, such as Harley-Davidson, into India as an example of “discriminatory” trade practice.
In an address to a joint session of Congress in February 2017, the President hinted at mistreatment to Harley-Davidson due to high import duties of as much as 100 per cent in foreign markets, but did not name India. On February 26, days after India announced an abrupt slashing of duties on imported motorcycles, Trump made it clear that he did not think the cuts were enough.’
India’s medical device technology market is worth about $6 billion, and is expected to grow to $50 billion by 2025. Currently, India imports around 80 per cent of its medical devices, a quarter of it from companies based in the United States.
AdvaMed’s briefing memo stated: “India’s policies could significantly hinder the growth of US exports… These price controls favour domestic producers by failing to differentiate their products covered by price controls… The Health Minister (J P Nadda) announced consideration of bringing additional ‘critical medical devices’ under price controls.”
AdvaMed’s briefing memo stated its hope that intervention by the US Department of Commerce as well as the USTR office “at senior levels — and possibly President Trump if he sees Prime Minister Modi — will stop the Modi Government from using its ‘Make in India’ policy to discriminate further”.
It added: “For the past decade, AdvaMed has continued to work with the Indian government to develop a distinct regulatory system specific to medical devices based on international standards. The Indian Parliament has failed to pass the necessary legislation.” The Medical Device Bill, which has been in discussion for many years, is yet to be tabled in Parliament.
In response to queries from The Indian Express on the memo, AdvaMed said: “AdvaMed as a global organization, representing innovation led medical technology companies, is in constant dialogues with different stakeholders, to seek collaborative solutions towards access to pioneering technologies that are focused on ‘Quality, Safety and clinical outcomes’. As part of this ongoing dialogue, we have been in touch with several stakeholders and have conducted multiple conversations — each possessing its own context and background. Therefore, to pick isolated conversations without putting that in perspective, and to also understand the background may not reflect the true picture. Thereby, it will lead to misguiding the audience…”
It said: “We would like to take this opportunity to provide our view and intent that will help you understand the overall picture and place some of the conversations in their rightful place. We believe that AdvaMed, as well as the Government of India, are aligned towards the larger goal of ensuring access to affordable and quality healthcare, while building an environment that is ‘innovation friendly, predictable and sustainable’.”