“Largest challenge to medical devices is the application of inappropriate regulations”

In an exclusive interview with the BioVoice News, Ms Abby Pratt, Vice President-Global Strategy and Analysis, AdvaMed gave insights on the various aspects of the Indian medical devices industry

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Ms Abby Pratt, Vice President-Global Strategy and Analysis, AdvaMed (Advanced Medical Technology Association).

As a senior government relations and public policy professional, Ms Abby Pratt, Vice President-Global Strategy and Analysis, AdvaMed (Advanced Medical Technology Association) oversees healthcare policy and global advocacy strategy promoting patient access to medical technologies in emerging markets. Ms Pratt engages with key global health organizations and agencies. Here in an online conversation with the BioVoice’s Rahul Koul, she spoke on the immediate burning issues involving medical technology business in India. Read on to know her reactions:

BV_icon_finalGovernment says it has the right to ensure reduction of the prices if average middle class in India is unable to afford them. Why do you think that the price control measures on medical devices aren’t of much help to affordability?

Price control doesn’t guarantee equitable access. Medical device cost is not the largest contributor to the overall procedure cost. The cost of life-saving medical device(s) is a small proportion in the overall healthcare expenditure. Drug related expenditure, doctor’s fee and IPD expenditure, travel and hospital stay are also important aspects of treatment that take a financial toll on the patients seeking treatment.

Therefore, reduction in the prices of medical devices alone without change or regulations in other healthcare costs would not result in overall reduction of procedure cost. In addition, over the last few years, medical device prices have either decreased while other healthcare services and products (drugs and procedure prices) have increased or remained stable.

BV_icon_finalIs there really a need for a separate regulatory framework for devices and equipment? What are the justifications for that?

The absence of a separate regulatory framework is one of the biggest challenges facing the med-tech industry in India. Presently, medical devices are governed by the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The current regulatory structure has its own barriers and limitations such as complex rules and guidelines, high capital investment, lack of active participation from the government and low penetration.

Being regulated by similar framework as for drugs, medical devices companies feel restricted and over-regulated. Establishing a separate regulatory body for medical devices will create a clear ownership within the Government to push the medical devices agenda as well as promote growth for the sector.

The largest challenge to medical devices being regulated as pharmaceuticals is the application of inappropriate rules and regulations. It’s not a matter of being over or under regulated, it’s that the regulations don’t apply to medical devices and don’t reflect the nature of the technology (the risk-level of the device, the life cycle of the products, the way it is packaged and used by physicians). The diverse world of medical devices cannot be regulated like a pill that can be purchased at a pharmacy. Our industry needs regulations that are appropriate to the technology and regulators who understand medical devices.

The success of the medical devices sector lies in a supportive regulatory environment which would allow players to conform to their core objective of being able to provide efficient devices and therefore, deliver the best quality assurance and meet patients’ complex and increasing healthcare needs.

“The largest challenge to medical devices being regulated as pharmaceuticals is the application of inappropriate rules and regulations. It’s not a matter of being over or under regulated, it’s that the regulations don’t apply to medical devices and don’t reflect the nature of the technology (the risk-level of the device, the life cycle of the products, the way it is packaged and used by physicians).”

BV_icon_finalHave you approached the concerned ministry on these issues so far? What has been the response from the government on your demands? 

We have been in touch with government officials and policy makers responsible for bringing about change to the medical devices sector. Regulatory bodies have realized the need to frame guidelines that will treat medical devices as a separate entity from drugs.

Creating a separate regulatory framework for medical devices will be the first step in addressing the needs of the med-tech sector.

Some of the steps the government can take include increasing overall spending on healthcare and per capita spend on medical devices, introducing greater insurance coverage, creating incentives for investment and R&D and undertake and disseminate research on medical devices.

BV_icon_finalHow do you react to the comments by activists that the MNCs have been overcharging the patients and the products a few times are lacking on quality? 

Reliable and safe devices for patients form the very foundation of the medical devices industry. Quality is the number one priority for our industry, demonstrated by the safety and effectiveness of the device. The benefits of medical devices in saving people’s lives surpass their costs several times over. From simple devices such as thermometers and syringes to life-saving devices like stents, pacemakers, ultrasound machines and surgical robots, manufacturing companies spend abundant financial and human resources to ensure safe, timely delivery of medical equipment. Medical devices are not the primary driver of cost. Other healthcare costs, for instance, doctor fees, hospital charges, and travel and IPD costs also make up for a large part of the healthcare and procedure costs.

“While the government’s initial approach was to not just promote indigenous manufacturing but also encourage MNCs to come and manufacture in India, a combination of price regulation on medical devices and hiking imports duty would only discourage the latter.”

BV_icon_finalYour thoughts on the Indian market opportunities and the challenges that come with it? As an Association, what do you think of the government’s make in India campaign?

The Indian market has diverse opportunities for the growth of the medical devices sector. With the dominant startup culture and trend in India, there are an increasing number of people innovating and inventing products based on novel ideas. However, for individuals and companies to continue innovating, they need the government’s support in terms of capital investment.

The ‘Make in India campaign’ has a mandate to boost the medical device-manufacturing sector in India for all types of medical devices and equipment used in manufacturing of Pharmaceuticals. But while the government’s initial approach was to not just promote indigenous manufacturing but also encourage MNCs to come and manufacture in India, a combination of price regulation on medical devices and hiking imports duty would only discourage the latter.

While the industry is supportive of enhancing domestic capacity and production, safety of the patient is paramount. Make in India will be a successful campaign for the medical devices sector as long as it keeps in mind the best interests of manufacturing companies as well as the patients needs which are of paramount importance.