A recent petition by multinational medical device manufacturers in the US requesting the withdrawal of certain trade benefits to India has raised the hackles of health advocacy groups, ahead of the India-United States trade policy forum in Washington tomorrow.

The petition by the Advanced Medical Technology Association (AdvaMed) was in reaction to cardiac stents and orthopaedic products being brought under price control and the imminent possibility of more to follow.

AdvaMed's President and Chief Executive Scott Whitaker filed the petition with the US Trade Representative (USTR) requesting that India’s benefits under the Generalised System of Preferences (GSP) be suspended or withdrawn following India’s failure to provide equitable and reasonable access to its market for medical devices, the lobby group said. (The GSP is a trade preference programme under which the US provides duty-free treatment to imports from beneficiary developing countries.)

Expressing concern on this development, the All India Drug Action Network (AIDAN) has urged the Indian government “to uphold the constitutional obligation on right to health and reject any pressure to review price controls on medical devices.”

“We call on the US government to refrain from exerting policy pressure on India for taking measures to make medicines and medical devices more affordable and accessible to patients that need them,” an AIDAN note said, even as Commerce Ministry officials headed to Washington for the trade meeting.

According to available data about 10,800-odd items (from meat products to edible vegetables, coffee, tea, spices, leather, etc) could be impacted by the GSP concession, said KM Gopakumar with Third World Network. But save a few products, a substantial number of items will only be marginally impacted by an average of four per cent, he said.

Drawing parallels with the pharmaceutical industry, AIDAN said, “In the past, the US biopharmaceutical industry has used similar tactics – backed by the US government – to pressurise the Department of Industrial Policy & Promotion (DIPP), Ministry of Commerce and Industry, to roll back decisions related to the rejection of patents on critical medicines such as sofosbuvir for hepatitis C. The US pharmaceutical lobby has also attempted to create barriers for the issuance of compulsory licences on patented cancer medicines such as dasatinib, which are priced out of reach of most patients in India.”

The decision to regulate prices of cardiovascular stents and knee implants has “put an end to the rampant overcharging and the exploitation of patients by hospitals, doctors and companies”, the note said, referring to the Indian price regulator's data that had revealed up to 1,000 per cent margins at various levels on cardiac stents.

AdvaMed's plaint

Last week, AdvaMed said its decision to file a petition with the USTR was taken “after months of discussions and careful consideration, and with regret” since there was “no alternative”.

Its members were deeply concerned about price controls on coronary stents and knee replacement implants in India that slashed prices by as much as 85 per cent and 70 per cent, respectively, followed by signals that price caps for additional life-saving and life-improving medical devices may be forthcoming, AdvaMed said.

Expressing its commitment to working with all healthcare stakeholders in India to find mutually acceptable and sustainable solutions to improving patient access to life-changing innovations from the medical technology industry, the group added, “Our intention is not for India to lose the benefits of GSP, but rather to advance engagement and meaningful discussions on restoring market access for medtech in India while keeping patients’ interests at the centre of all discussions.”

India’s singular focus on controlling ceiling prices of high-quality medical devices, without any attempt to address the larger picture and correct inefficiencies in the healthcare system, will not achieve its intended benefits, it added. Infact, medical devices are only one component of overall procedure costs, it said, pointing to reports that price reductions on devices had not been passed on to patients.

jyothi.datta@thehindu.co.in