‘Without Providing Affordable Medicines, There Can’t be Health Security’, said the Union Minister of Chemicals and Fertilizers of India, as reported on September 22, 2017. Although, the Minister made this remark while discussing Government price control on cardiac stents in India, let me dwell on the subject based on the above news headline by asking: Is drug price control improving access to medicines for greater ‘Health Security’ of the country?

It’s no rocket science to understand that making affordable drugs ‘available’ in requisite quantity for all, is essential, basically, for improving ‘access’ to medicines. Nevertheless, the mere availability of drugs is no guarantee for their improving access to all.

If we take a closer look at the well-articulated key objectives of the Ministry of Chemicals and Fertilizers, under which both the Department of Pharmaceutical (DoP) and the National Pharmaceutical Pricing Authority (NPPA) belong, this dichotomy will be easier to fathom.

The key objective of the ‘National Pharmaceutical Pricing Policy: 2012’, which is operational today, reads as: “To put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines – “essential medicines” – at reasonable prices even while providing sufficient opportunity for innovation and competition to support the growth of the industry, thereby meeting the goals of employment and shared economic well-being for all. The reasons are further elaborated later in the Policy Document.”

Similarly, according to the NPPA, one of the key objectives of drug price control in India is to ensure abundant availability, at reasonable prices of essential and life-saving and prophylactic medicines of good quality. Hence, the current key focus of the DoP and NPPA, on paper, does not go beyond making ‘affordable drugs available for all.”

Thus, the crucial point to ponder: Is ongoing drug price control, improving even availability of medicines for all to attain greater ‘health security’ of the country, as the Union Minister underscores?

A course correction without flagging the new course:

The Draft Pharma Policy 2017 makes an important course correction to address this critical issue. It expresses its objective in this important area slightly differently, by adding the word ‘accessible’, as: “Making essential drugs ‘accessible’ at ‘affordable prices’ to the common masses.”

Intriguingly, the draft remains mute, when it boils down to answering the fundamental question, how would this new policy improve access to affordable drugs for the common masses, without having any jurisdiction to improving access to overall health care? That turf, unquestionably, belongs to the Ministry of Health. Thus, I reckon, achieving this modified goal, in its totality, is no more than a rhetoric.

Would better availability guarantee greater patient access to drugs?

As things stand today, it is quite unlikely to happen. The broad process of improving access to health care in a holistic way, is enshrined in the  National Health Policy 2017, which is already in place. It assures the nation of progressively achieving ‘Universal Health Coverage (UHC)’. It outlines measures to improve the availability, access and affordability for quality secondary and tertiary care services, with significant reduction in ‘out of pocket expenditure’ on health care. The policy also emphasizes that this process would considerably reduce the proportion of households experiencing catastrophic health expenditures, and consequent impoverishment.

The silo mentality won’t work:

Although, the Ministry of Health is primarily responsible for meeting universal access to health care, which includes drugs, the Ministry of Chemicals and Fertilizers too, shoulders a crucial responsibility in this area. Thus, attaining the Health and Pharma policy goals – individually, collectively and meaningfully, both these Ministries need to work closely together, along with the State Governments, in the true spirit of cooperative federalism. The silo mentality has not worked and won’t work, ever, to meet health aspirations of the people.

Access to health care – a prerequisite to improving access to affordable drugs:

As I see it, access to health care for all is a prerequisite to improving access to affordable drugs for country’s ‘health security’. Without providing access to requisite health care, making affordable drugs available for all, does not make much sense, if at all. This is because, patients will buy or get medicines only when a medical or paramedical professional will advise and prescribe them what to buy while treating any particular ailment.

Is the key pharma policy goal anywhere near its target?

Be that as it may, let me now try to gauge whether even the current key goal of the pharma policy to make an increasing quantity of affordable drugs available to more number of the population is anywhere near its target or not.

Capturing the impact of the present pharma policy on the ‘health’ of Indian pharma industry, the Annual Report 2016-17 of the Department of Pharmaceuticals (DoP) acknowledges that owing to the Government’s efforts to make medicines affordable, the domestic Pharma market witnessed a slowdown in the ongoing financial year. The industry registered a decline in growth of 7.4 percent over the corresponding figure for 2014 -15, with a similar aftermath in its financial performance.

Interestingly, a Press Release of Ministry of Chemicals and Fertilizers of September 27, 2016 claims that ‘ceiling prices’ of 464 formulations fixed after announcement of NLEM, 2015 and Revised Schedule-I, resulted in savings of Rs 2288 crore for consumers. Let me also add that a September 22, 2017 tweet of the same Union Minister gives a much higher number in this regard, which includes cardiac stents, though.

Fair enough, in that increasing patient access to affordable drugs ought to get reflected in the reasonable incremental volume growth of the Indian Pharmaceutical Market (IPM), at least, of those products, which feature in the National List of Essential Medicines (NLEM)? Contrary to this expectation, according to an article published by ‘Pharmabiz’ website on the CPhI India Special supplement in December 2016, ‘over the past 3 years (FY 2013 – FY 2016), the IPM has grown at a CAGR of ~ 11%, much lower than its historical average growth rate of 15%.’

Thus, both the private retail audit data, and also the submission of the DoP clearly indicate that this has not happened, as a desired outcome of drug price control.

Drug price regulations aren’t irrelevant either:

My above argument doesn’t also mean that drug price control, or stringent price monitoring, or tough price negotiation – in whatever way one may call it, is of no use; even where Universal Health Care (UHC) is up and running. This is regardless of whether this universal care is insurance driven, as in the United States, or state funded, as in the United Kingdom. As I said before, access to health care for all is a prerequisite to improving access to affordable drugs. I stressed this point briefly in one of my recent articles published in this blog, while focusing on another important development.

Drug price regulation in the UHC countries:

In case of insurance driven UHC, insurance companies or related payers, or even the regulators, mostly enforce stringent control on drug prices, as is currently happening in the United States. This fact is vindicated by a May 29, 2017 report that indicates: “The pharma industry, under the constant glare of the US drug regulator, has to contend now with pricing pressures in the American market.” The report further highlighted: “From Sun Pharma and Lupin to Glenmark, Dr. Reddy’s and the others, price erosion in generic drugs has been a common anguish as they declared their results for the fourth quarter ended March 31. For some of these companies, more than 40 per cent of their revenues come from the US market. The developments came at a time new launches in the US – at least for some of them – have taken a hit because of regulatory action. Pricing pressure in generics is not new, but this has exacerbated in recent times, with experts warning of further deterioration.”

Similarly, where the UHC is funded by the State, such as in the United Kingdom, prices of branded pharmaceuticals supplied to the National Health Service (NHS), are controlled either by the ‘Pharmaceutical Price Regulation Scheme (PPRS)’ or by the ‘Health Service Branded Medicines Regulations 2008’. The situation is no different virtually in the entire Europe.

Moreover, in Japan, where UHC functions so immaculately, the regulatory officials of the country announced in December, as reported on 7th March 2017, the Government plans to review drug prices more frequently –  annually for all therapies and quarterly for the newest, and most expensive ones that are used widely. Over recent months, the price of Opdivo, a blockbuster cancer drug from Bristol-Myers Squibb Co. and Japan’s Ono Pharmaceutical Co., was halved in Japan following a 32 percent cut in April for Gilead Sciences Inc.’s hepatitis cure Sovaldi, the report said.

In addition, an OECD report dated January 16, 2017 observes: “The proliferation of high-cost medicines and rising drug prices are increasing pressures on public health spending and calling into question the pharmaceutical industry’s pricing strategies. Governments need to work with the industry and regulators to define a new approach to the development and use of new health technologies that encourages innovation while also delivering more affordable and value for money treatments.”

Hence, drug price regulations aren’t irrelevant, either in India or even in countries with a robust UHC system in place, not just yet.

The rationale behind drug price control in UHC countries and India:

The major difference in the rationale of drug price control between the countries with UHC and others, such as India is as follows:

• UHC countries extend health coverage between 80 to 100 percent of the population, on an average, with a very low percentage of ‘out of pocket expenses’ on drugs. Hence, the Government and other payers want to keep their own cost of drugs within a reasonable limit with drug price control, though its methodology varies from country to country.

• On the other hand, in countries, such as India, where UHC is not available, over 70 percent of the population incur ‘out of pocket’ expenses on health care – and over 60 percent of which is spent on drugs. Hence, the Government intends to ensure a significant reduction in ‘out of pocket expenditure’ towards medicines, by trying to make more affordable drugs available to many through drug price control.

Conclusion:

All health care related policy measures of the Government are important for the nation. As I know, the related discussion papers are circulated by the Government only after several informal and ongoing discussions on the subject with the stakeholders, and considering other feedbacks received in that process.

Despite this general mechanism, several points of draft proposals, or even the final policy, are often not liked by all, triggering a raging debate and inviting stringent criticisms, including disagreement from other ministries. For example, according to reports: “Even as Prime Minister Narendra Modi announced the government’s intention to ensure access to affordable medicines, the government policy think tank NITI Aayog seems to be pushing for greater deregulation of drug prices and to disempower India’s drug price regulator.” Just as many others, I also often participate in such debates.

That said, improving not just availability, but in tandem with greater access to affordable drugs, would play a key role to foster overall ‘Health Security’ of the country. Drug price control or its equivalent measures, alone, does not improve access to affordable drugs, except shaving off significant revenue and profit of the pharma companies. Whether the appropriate terminology in this case would be ‘profit’ or ‘profiteering’, is part of a separate debate, altogether.

Neither, impeccable sets of pharma and health policies, implemented in-silo by the two different ministries, will help achieve this goal. As is well researched, an excellent policy with shoddy or improper implementation, fetches far worse outcome than an average policy when implemented well, and in close coordination with other policies having common goals. This holds good even while striving for a robust ‘Health Security’ for the country.

By: Tapan J. Ray 

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.