Tag Archives: forward

Keep Pace with Pharma’s Even Nuanced Technology Driven Changes – For Success

Posted on by
Reply

Since 2020, unprecedented global disruptions affecting lives, livelihoods, and business, have impacted India in equal measure, if not more – across various areas, including the pharma industry. If there is one change that is creating a snowballing effect, is the rate of progress and use of technology in its operations.

Consequently, finding properly trained people, to drive the new avatar of technology driven today’s business – right from R&D, supply chain, manufacturing, sales and marketing, customer behavior, market dynamics – poses a facet of ongoing challenges.

This is primarily because, some key business-success requirements have now significantly changed, but many are still nuanced that one may tend to possibly ignore. Thus, early identification of these and placing properly skilled – right people in the right job, who can floor the gas pedal in search of excellence, assume two key priorities for the pharma players, more than ever before.

Most companies, as I understand, are finding this task quite time consuming, if not arduous. The options are basically two. The first one – spot, search and hire the best talent from outside the organization. And the second – spot the internal talents, hone their skills, handhold them for some time on the job, before they take charge and assume accountability for achieving the set goals. In this article, I shall focus on the relevance, criticality, and associated intricacies that pharma leadership may encounter in this process.

Intense focus on the drug industry in last two years – blessings and burden:

A recent research study on Talent Trends For Life Sciences Organizations, published by Randstad Sourceright on July 22, 2022, came out with some interesting findings in this area. The key ones are as below:

  • In the past couple of years, the intense global focus on Life Sciences Industries brings both blessings and burden on the industry.
  • Key drug manufacturers received unprecedented levels of financial and regulatory support for the development of therapies and vaccines for the treatment and prevention of Covid-19 onslaught on the people across the world.
  • In tandem, the drug industry had to withstand tremendous pressures and intense scrutiny to achieve this task by re-prioritizing their R&D focus, which no drug manufacturer had experienced ever before.

Alongside, pharma customer characteristics and behavior also started changing fast in many areas, and consequently the market dynamics. Many of these changes are still nuanced and are driven by contemporary technology. Amid lesser concern for Covid-pandemic, the ongoing metamorphosis in the world of work – impacting almost all functional areas of a customer-driven organization, poses a fresh pharma leadership challenge.

Thus, for future business success, pharma companies now need to capture relevant real-time data, and analyze them to gain in-depth insight of these changes. Consequently, it is important to figure out how much the quality of talent requirement has changed for an organization, to continue to remain as patient centric. However, before doing that, it’s worth figuring out what kept the wheels of pharma businesses moving during the years of the recent pandemic.

What kept the wheels of business moving during the pandemic:

Several important studies have made dip-stick assessment in this space. One such recent study findings of Randstad Sourceright highlighted the following three, among others, as the key success factors for employee motivation in trying times, which kept the wheels of business moving:

  • Empathy of the leadership,
  • Flexibility in work life
  • Ingenuity of employees to quickly adapt to the new normal

Some of these, or all, may linger in the minds of many employees. They may still long for empathy at work and flexibility in the workplace, to unleash their full potential for organizational success. Otherwise, they may look outside, especially to those companies who can meet their expectations, in the new normal.

In this situation, fostering EQ within the organization to encourage employees committing to the corporate shared goal, is a key requirement for pharma’s performance excellence. The bottom-line is,how well an organization continues to nurture and retain or attract new talents, besides honing their skills in line with the changing customer value delivery process, would be critical.

Need to identify even nuanced changes in workplaces:

Thus, before making a dip-stick assessment to ascertain the changes in organizational talent requirements, it is worth getting a sense from the available studies what’s going on today in the industry.

Like many other countries, the pandemic is no longer an unsettling unease for most pharma organizations in India. At the same time, studies reiterate that it’s for sure that the pandemic related disruptions have ushered-in visible or nuanced transformations, especially in the operational areas of the life sciences business.

Some recent studies, such as, one done by McKinsey & Company on – Creating the workforce of the future, made a notable observation. It emphasized, “Pharma companies struggle to predict where they will see the talent gaps, these disruptions create, though a majority monitor key trends and track talent needs. Only a minority of companies (40 percent) believe that they really know which skills are needed now, let alone in ten years (less than 25 percent).”

Which is why, I reckon, it is now critical for the Indian pharma leadership to identify, analyze and address, both perceptible and nuanced transformation within their customers, employees, and other stakeholders. And then zero-in on changing talent requirements of employees in key operational areas, including sales and marketing – to gain a competitive edge in the marketplace.

However, it is worth remembering that the supply of quality talent remains limited, although it is essential to catapult the business in a higher growth trajectory. Besides, gradually changing employee expectations in the workplace culture – work-flexibility could emerge as another sought after factor to attract new talents from the millennials. 

The ways to move forward in this area:

Many companies may decide to hire new talents from outside the company, whereas some may look for developing people internally, through well-structured internal human development initiatives. However, the research study of Randstad Sourceright finds: ‘67% of life science and pharma leaders believe reskilling and upskilling employees for different roles is an effective way to address talent scarcity. Additionally, 63% say they already invest in internal mobility platforms to augment their recruiting efforts, while 53% plan to increase their investments in this area.’

Further McKinsey & Company in their above-mentioned article also suggested: ‘Reskilling employees to address talent gaps can help a company retain the bulk of its operations workers and empower them to take advantage of a new world.’ So did another article on building pharma talent of tomorrow, published in the Pharma Executive on October 05, 2022. It emphasized that training current employees who already know the business, and are familiar with the inner workings, would expectedly take much less time to deliver that is expected of them.

I also understand, a few large Indian pharma majors are also focusing on internal talent development as one of the key organizational development initiatives. They are identifying internal talents in an organized manner, up-skill them to shoulder new responsibilities – following a well-charted career path for each one of them. It’s important for the leadership to demonstrate and make these employees also feel that they are of great value to the organization.

From the above perspective, I reckon, in today’s environment when many employees are eager to search for a greener pasture that suits them better, the above approach also provides an opportunity for pharma employers. This opportunity is primarily to retain talents, by incentivizing them with learning, and development process, besides a chance for career progress in the company.

Conclusion:

One thing for sure is critical to ensure that right talents are always placed in the right job. This is crucial to keep pace with not just significant transformations. But even for emerging and nuanced technology driven changes in customer characteristics, behavior, and market dynamics. Thereafter, each organization will need to identify available in-house talents for upskilling, honing and development. Whereas some fresh new talents may necessarily be required to hire from outside or outsourced.

Several recent studies have also indicated that the best strategy in this regard, is the optimal combination of hiring from outside or outsourcing the new requirements, alongside internal talent development initiatives, and charting a career path for them. To chart on this emerging frontier calls for a mindset change. Thus, it is important for us to remember that only permanent factor in the pharma business is – change. Can one ignore it? Of course, but at one’s own peril, because in the long run “What You Do is Who You Are” in the future pharma business.

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.

 

Creating ‘Shared Value’ in Pharma – The Way Forward

Posted on by
Reply

Many Pharmaceutical companies, both global and local, are struggling with a plethora of critical challenges. With the industry reputation diving south successful navigation through this headwind has become an onerous task, more than ever before.

Under this backdrop, the article, titled “Creating Shared Value” of Michael Porter and Mark Kramer, published in the Harvard Business Review (HBR) in its January – February 2011 issue, becomes very relevant to analyze the situation.

The paper says: “Companies are widely thought to be prospering at the expense of their communities. Trust in business has fallen to new lows, leading government officials to set policies that undermine competitiveness and sap economic growth. Business is caught in a vicious circle. A big part of the problem lies with companies themselves, which remain trapped in an outdated, narrow approach to value creation.”

The authors also articulated that pharma players, generally focus on optimizing short-term financial performance, overlooking the greatest unmet needs in the market as well as broader influences on their long-term success. They questioned: “Why else would companies ignore the well-being of their customers and the economic distress of the communities in which they produce and sell?”

Porter and Kramer advised the companies to bring business and society back together – redefining their purpose as creating “shared values”. It means generating economic value in a way that also produces value for society by addressing its challenges.In this article, I shall explore in this area.

Not CSR or Philanthropy, its engaging business as business, for social progress:

Creation of “Shared values” for a business is quite different from “Philanthropy” or “Corporate Social Responsivity (CSR)”. Philanthropy usually involves ‘donations to worthy social causes’ and CSR is primarily directed at compliance with community standards and good corporate citizenship. Whereas the creation of “shared value” means integrating societal improvement into economic value creation, making social improvement as an integral part of with a business model.

To create “shared values”, it is imperative for business organizations to create “social value” through active participation in addressing the social issues and needs related to the business. Or in other words, the creation of “shared values” would entail striking a right balance between “social value” and the “business value.”

An article titled “What Is the Social Value of Pharmaceuticals?”, published by FSG on February 13, 2014 dwells on the business relevance of creation of “social value” in the pharma industry. It writes,creation of “social value” corresponds to effecting positive change along the major societal challenges, such as affordable health care, by working more in collaboration with other stakeholders to address the needs of the underserved through commensurate value creation. This entails engagement of a business as a business, not as a charitable donor, nor through public relations, for social progress.

A resolution to create “shared value” in the pharma industry:

An interesting article, featured in SFGATE of the San Francisco Chronicle on July 11, 2018, elucidated that the reputations of drug makers have taken a hit over the past few years as the public and politicians have called out the companies for high prescription drug prices that even Americans are facing. Recently, President Donald Trump, reportedly, singled out the top pharma companies of the world  for raising the list prices on some of its prescriptions.

Possibly it’s a sheer coincidence, but on the same day, an intent of creating “shared values” with the society got reflected in the statement of the president of the Novartis Institutes for Biomedical Research. The officialexplained, why his company has a ‘contract with society’. He admitted that: The cost of health care, which has been rising has left many on the hook for a larger amount of their prescription drug cost that can place a big burden on patients in many countries, including the United States.

Consequently, the pressure from the people who need medications is now on the pharmaceutical companies for doing right, he added. Thus, Novartis feels:”We have a contract with society, and society is our shareholder. A company like ours exists to have a definitive impact on life threatening diseases, to keep people alive and healthy for a long, long time, full stop” – the official concluded.

A laudable intent, but is it credible?

The concept of pharma having a contract with the society ‘to keep people alive and healthy for a long, long time,’ is laudable, but is it credible? This question arises because, just before public articulation of this intent, the same company, reportedly, entered into USD 1.2-million contract with President Trump’s lawyer, Michael Cohen, allegedly, to provide access to the US President.

The exact reason for the same is being investigated by competent authorities, including the US Senators. However, another report highlighted, “Novartis is among the drug companies that has put through significant price increases for its products since Trump took office in 2017 – in some cases more than 20 percent.”

Another  repot of July 09, 2018, quoting a tweet of the US President, poured more cold water on the warm intent of pharma’s ‘contract with the society.’ According to this article President Trump tweeted: “Pfizer & others should be ashamed that they have raised drug prices for no reason. They are merely taking advantage of the poor & others unable to defend themselves, while at the same time giving bargain basement prices to other countries in Europe & elsewhere. We will respond!”

Consistently declining pharma’s image and public trust:

Many believe that due to such hyperbolic statements and conflicting actions of pharma, over a long period time, are driving down the public image and trust on the industry, in general, from deep to deeper level, which has not found its bottom, just yet.

The reality gets reflected in various well-recognized polls, conducted even in the top pharma market of the world, which is also one of the richest nations, globally. August 2017 Gallup Poll on ‘Business and Industry Sector Ratings,’ features pharma industry at the very bottom of the ranking, just above the Federal government.

The concern gets reverberated in the February 03, 2017 article titled, ‘How Pharma Can Fix Its Reputation and Its Business at the Same Time,’ published in the Harvard Business Review (HBR). The paper observes that the worrisome mix of little growth potential and low reputation prompts the pharma players, among other actions, developing new treatments for neglected populations, and pricing existing products at affordable levels – avoiding corruption and price collusion.

How will “shared value” creation help pharma?

The process of creating “shared values” will involve creating “social value” with all sincerity and a clearly defined purpose. Its outcome should be measurable, and the impact felt by the society. In tandem, striking a right balance between “social value” and the “business value” would call for a metamorphosis in the concept of doing business.

There aren’t too many examples of creation ‘shared values’ by pharma companies, yet. However, to illustrate this point, let me quote one such that was originated from India, which I had the privilege to observe closely. This initiative is ‘Arogya Parivar (healthy family) of Novartis in India.

‘Arogya Parivar’ is a ‘for-profit’ social initiative developed by Novartis to reach the under-served millions living at the bottom of the pyramid in rural India. As Novartis claims, since its launch in 2007, ‘Arogya Parivar’ is proving to be both a force for improving health in rural communities and a sustainable business. ‘Arogya Parivar’ is a commercially-viable program and began returning a profit after 30 months with sales increasing 25-fold, since launch. After successful implementation of this initiative in India, the company has created similar programs in Kenya, Indonesia and Vietnam, according to Novartis.

Conclusion:

The concept of ‘shared values’ emphasizes that business success of a company is closely related to the progress, development and wellbeing of the society where it transacts the business. This can be achieved by striking a right balance between the social need and the business need. In the pharma space too, the value creation in the business value chain may need to be redesigned to meet the ‘social value’. This happened as in the case of ‘Arogya Parivar’ initiative of Novartis in India.

Creating robust business models based on ‘shared values’, in sync with the business-specific needs of the society can help make more profit in areas where there is none, at present. It will also facilitate achieving additional growth of the organization and improve long-term competitiveness.

Consequently, pharma can earn recognition of the society as a powerful contributor for containing suffering and even death of many ailing patients, by increasing access to affordable medicines for those who need these most. This, in turn, would help pharma companies to improve their public image and reputation. Let me hasten to add that provided, of course, no countermeasures are taken by them, surreptitiously, as I have discussed above.

The good news is, some pharma players have already initiated action in this direction. Thus, I reckon, many of them would soon realize that creating ‘shared value – based’ business models are the way forward for sustainable business excellence.

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.

“Big Pharma’s Satanic Plot is Genocide”: South Africa Roars

Posted on by
Reply

In a recent interview, the Health Minister of South Africa (SA) Mr. Aaron Motsoaledi reportedly made the above comment.

The background:

As reported in the interview and also indicated in an article in this blog, the Trade and Industry Department of SA, on September 4, 2013, published a long-awaited draft national policy on Intellectual Property (IP) in the Government Gazette. In that draft policy, the department recommended, besides others, the following:

  • Provision should be made for the Compulsory Licensing (CL) of crucial drugs.
  • Provision should be made for the parallel importation of drugs.
  • Grant of drug patents should ensure that the drug is new or innovative.
  • “Patent flexibility” for medicine should be made a matter of law.
  • The holders of Intellectual Property Rights (IPR), such as drug companies, should be encouraged to protect their own rights rather than depending on state institutions, such as the police or customs.
  • SA should seek to influence the region, and the world, to move towards its vision of Intellectual Property (IP) protection.

The draft does not have the status of a policy, as yet, and was open for public comment.

Pharma MNC moved surreptitiously: 

Pharma MNCs having local operations being flabbergasted by this development, almost immediately, started working on a plan to change the direction of the policy radically, the report states. Instead of optimal protection for drug patents, they planned to seek stronger protection. 

Having finalized the counter strategy this month, the local MNC pharma association, ‘Innovative Pharmaceutical Association of South Africa (Ipasa)’, reportedly selected a Washington DC-based lobbying firm ‘Public Affairs Engagement (PAE)’, headed by a former US ambassador – Mr. James Glassman, to lead the charge against the policy. PAE, by now, has put forward a proposal on how it would effect radical changes to the policy, the report stated.

The same article mentions, PAE intends to launch a persuasive campaign throughout Africa and in Europe with an aim to convince the South African Government to further strengthen, rather than weaken, patent protection for drugs. The grand plan of PAE contains elements, which could seriously bother many right thinking individuals, as it includes:

  • Setting up a “coalition” with an innocuous name such as “Forward South Africa (FSA)”, which will be directed from Washington DC, while appearing to be locally run in SA.
  • Encouraging other African countries, especially Rwanda and Tanzania, to help convincing SA that it could lose its leadership role in the continent, if it decides to push ahead with the draft policy.
  • Distracting NGOs from their own lobbying by changing the nature of the debate.
  • Commissioning seemingly “independent” research and opinion pieces for broad public dissemination – but vetting all such material before publication to ensure those fit the messages. 

Creation of surrogate public faces:

It is worth noting from the report that the so called coalition ‘FSA’, the proposed public face of the campaign, would be “led by a visible South African, most likely a respected former government official, business leader or academic”. However, at the same time, it would be “directed by staff from PAE and its South African partner”.

Majority funding by an American association in SA:

The report also highlights, nothing in the document suggests that the funding for FSA – estimated at  mind-boggling numbers of U$ 100,000 from IPASA and another US$ 450,000 from an ‘American Association’ of pharmaceutical companies – would be disclosed.

The report concluded by quoting the American lobbyists hired to launch a counter campaign, which states, “Without a vigorous campaign, opponents of strong IP will prevail, not just in South Africa, but eventually in much of the rest of the developing world.”

This is not a solitary example:

The Guardian reported another such incident in July 2013. The article stated that the global pharmaceutical industry has “mobilized” an army of patient groups to lobby against the plan of European Medicines Agency (EMA) to force pharma companies to publish all Clinical Trial (CT) results in a public database for patients’ interest.

While some pharma players agreed to share the CT data as required, important global industry associations strongly resisted to this plan. The report indicated that a leaked letter from two large pharma trade associations, the Pharmaceutical Research and Manufacturers of America (PhRMA) of the United States and the European Federation of Pharmaceutical Industries and Associations (EFPIA), have drawn out a strategy to combat this move.

The strategy reportedly demonstrates, as the article highlights, how have the Big Pharma associations drawn the patient groups, many of which receive funding from drugs companies, into this battle.

Conclusion: 

As I had articulated several times in the past, newer innovative drugs are extremely important in the fight against diseases and this flow must continue, actively supported by a well-balanced Patents Act of the country, as India has already implemented.

That said, the moot question continues to remain, who are these innovations and innovative medicines for? Are these to save precious lives of only a small minority of affluent nations, their populations and other wealthy people elsewhere, depriving a vast majority, across the world, of the fruits of innovation? Would repeated harping on the much hyped phrase, “meeting unmet needs of patients”, negate such gross indifference?

If that is the case, it becomes the responsibility of a Government, keeping the civil society on board, to formulate effective remedial legal measures. The draft national policy on ‘Intellectual Property’ of SA is one such initiative that needs to be applauded.

Surreptitious reported attempts of pharma MNCs, repeatedly, through their respective associations, backed by bagful of ‘resources’ of all kinds to thwart such patient centric moves of Governments, should be deplored with contempt that they deserve.

As Indian scenario is no different, it would perhaps be good to fathom, whether similar surreptitious and high resource-intensives moves are in progress in this country as well.

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.

 

Innovative Public Private Partnership (PPP) in Healthcare Financing is the way forward to improve ‘Affordability’ and ‘Access’ to Healthcare’ in India

Posted on by
Reply

Despite various measures taken by the Government of India (GoI), around 65% of the population do not have access to modern medicines in the country. Such medicines do not include treatment just for ‘Tropical Diseases’ like, Malaria, Tuberculosis, Filariasis or Leishmaniasis or even anaemia in women. These medicines, in fact, cover much wider spectrum of the primary healthcare needs of the country and include antibiotics, anti-hypertensive, anti-diabetics, anti-arthritic, anti-ulcerants, cardiovascular, oncology. anti-retroviral etc. Many stakeholders in the country, including the policy makers feel that the reason for poor access to medicines to a vast majority of Indian population is intimately linked to the affordability of medicines.

A bold public measure to achieve the dual objectives:                           To make medicines affordable to the common man and at the same time to create a robust domestic pharmaceutical industry in the country, the Government took a bold step in early 1970 by passing a law to abolish product patent in India.

The changed paradigm, encouraged domestic pharmaceutical companies to manufacture and market even those latest drugs, which were protected by patents in many countries of the world, at that time. This policy decision of the GoI enabled the domestic players to specialize in ‘reverse engineering’ and launch the generic versions of most of the New Chemical Entities (NCEs) at a fraction of the innovators price, in India.
Simultaneously other low cost ‘essential medicines’ continued to be produced and marketed in the country.

‘Reverse Engineering’ – a huge commercial success in India:
From 1972 to 2005 domestic Indian pharmaceutical companies were replicating most, if not all the blockbuster drugs of the world, to their low price generic substitutes, just within a year or two from the date of their first launch in the developed markets of the world. These innovative drugs include quinolones. H2 Receptor anatagonists, proton pump inhibitors, calcium channel blockers, ace inhibitors, Cox2 inhibitors, statins, anti-coagulants, anti-asthmatic, anti-cancer, anti-HIV and many more.

In 1970, the Market share of the Indian domestic companies, as a percentage of turnover of the total pharmaceutical industry of India, was around 20%. During the era of ‘reverse engineering’, coupled with many top class manufacturing and marketing strategies, domestic Indian pharmaceutical companies wheezed past their multinational (MNCs) counterparts in the race of market share, exactly reversing the situation in 2010.

‘Reverse engineering’ was indeed one of the key growth drivers of domestic pharmaceutical industry. In its absence, during this period, the growth rate of branded generic industry may not be as spectacular.

India – now the ‘Eldorado’ of the pharmaceutical world:
This shift in the Paradigm in 1970, catapulted the Indian domestic pharmaceutical industry to a newer height of success. India in that process, over a period of time, could establish itself as a major force to reckon with in the generic pharmaceutical market of the world. Currently, the domestic pharmaceutical industry in India caters to around one third of the global requirement of generic pharmaceuticals and is a net foreign exchange earner for the country.

Currently, within top ten pharmaceutical companies of India, eight are domestic companies. All those global pharmaceutical companies who had left the shores of India and many more, have returned to the country after India signed the WTO agreement in January 1995 with great expectations.

Government feels quite confident and exudes a sense of accomplishment with its pharmaceutical policies:
The government therefore believes that a combination of these policy measures resulting in the stellar success of the domestic pharmaceutical companies since last four decades has helped the country earning the global recognition as one of the most attractive emerging pharmaceutical markets of the world, with commensurate and sustainable ascending growth trend.

Has stringent Price Control/Monitoring of Medicines worked in India?
Be that as it may, from 1970 to 2005, India could produce and offer even the latest NCEs at a fraction of their international price, to the Indian population. There are as many as 40 to over 60 Indian branded generic versions for each successful blockbuster drug of the world. Competition has been intense and cut-throat, which keeps the average price well within the reach of common man. Average price of medicines in India is even lower than that of Pakistan, Bangladesh and Sri Lanka. Thus the combination of price control, price monitoring, fear of price control and cut throat competition within branded generics have been able to drive down the prices of medicines in India.

Has the focus mostly on ‘Price’ been able to resolve the issue of poor access to modern medicines by the common man?                       Although the GoI should be complemented for the above measures and putting in place the Product Patents Act in India effective January 1, 2005, the issue of access to modern medicines to the common man has still remained unanswered in the country. Why then access to medicines in India is confined to just to 35% of the population even after 62 years of Independence of the country? Comparable figures of access for Africa and China are 53% and 85%, respectively. This is indeed an abysmal failure on the part of the government to achieve the core healthcare objective of the nation.

Strategy adopted to address the core issue of ‘affordability’ and ‘access’ to healthcare and medicines are grossly inadequate:
Despite the stellar success of the pharmaceutical industry in India thus far, there is a pressing need for the government to address this vexing problem without further delay. The situation demands from the policy makers to put in place a robust healthcare financing model in tandem with significant ‘capacity building’ exercise, initially in our primary and then in the secondary and tertiary healthcare value chain.

Towards this direction, the Federation of Indian Chambers of Commerce and Industry (FICCI) has suggested to the Government for an investment of around US$ 80 billion to create over 2 million hospital beds.

Government changing its role from ‘Healthcare Provider’ to ‘Healthcare Facilitator’:
Frugal budget allocation (0.9%) by the GoI towards healthcare as % of GDP of the country and its other healthcare related policy statements suggest that government is changing its role in this area from a healthcare provider to a healthcare facilitator for the private sectors to develop the healthcare space of the country adequately.

In such a scenario, it is indeed imperative for the government to realize that the lack of even basic healthcare financing model and primary healthcare infrastructure in many places across the country, leave aside other fiscal incentives, will impede the penetration of private sectors into semi-urban and rural areas. Innovative PPP model should be worked out to address such issues, effectively.

Laudable projects like NRHM and ‘Jan Aushadhi’ must deliver:
Over 70% of Indian population are located in rural India. A relatively recent study indicates that despite some major projects undertaken by the Governments, like National Rural Health Mission (NRHM), about 80% of doctors, 75% dispensaries and 60% of hospitals are located in urban India.

Another recent initiative taken by the Department of Pharmaceuticals (DoP) called ‘Jan Aushadhi’ is also orientated towards urban and semi-urban India. Unfortunately even in those areas the scheme has failed to deliver against the objectives set by the department of pharmaceuticals (DoP) themselves.
The net result of such a lack of firm intent to deliver by all concerned denies 65% of Indian population from having access to modern medicines and other basic healthcare services within the country.

Address the issue of ‘Affordability’ and ‘Access’ to medicines and healthcare with a robust ‘Health Insurance’ model for all:
While trying to find out a solution to these critical issues, by restricting the focus only on the ‘prices of medicines’ for several decades from now, the Government is doing a great disservice to the common man.
Let me hasten to add that I am in no way suggesting that the prices of medicines have no bearing on their ‘Affordability’. All I am suggesting here is that the issue of ‘Affordability’ and ‘Access’ to modern medicines could be better and more effectively addressed with a robust ‘Health Insurance’ model for all, in the country.

Sporadic initiatives towards this direction:

We find some sporadic initiatives in this direction for population below the poverty line (BPL) with Rashtriya Swasthya Bima Yojana (RSBY) and other health insurance schemes through micro health insurance units, especially in rural India. It has been reported that currently around 40 such schemes are active in the country. Most of the existing micro health insurance units run their own independent insurance schemes.

Some initiatives by the State Governments:

Following initiatives, though quite limited, are being taken by the state governments:

1. The Government of Andhra Pradesh has planned to offer health insurance cover under ‘Arogya Sri Health Insurance Scheme’ to 18 million families who are below the poverty line (BPL).

2. The Government of Karnataka has partnered with the private sector to provide low cost health insurance coverage to the farmers who previously had no access to insurance, under “Yeshaswini Insurance scheme”. This scheme covers insurance cover towards major surgery, including pre-existing conditions.

3. Some other state governments have also started offering public health insurance facilities to the rural poor, but not in a very organized manner. In fact, some private health insurers like Reliance General Insurance and ICICI Lombard General Insurance have been reported to have won some projects on health insurance from various state governments.
Covering domiciliary treatment through health insurance is important:

Currently health insurance schemes mostly cover expenses towards hospitalization. However, medical insurance schemes should also cover domiciliary treatment costs and loss of income, along with hospitalization costs.

Government policy reforms towards health insurance are essential:
Currently Indian health insurance segment is growing over 50% and according to PHD Chamber of Commerce and Industries the segment is estimated to grow to US$ 5.75 billion by 2010. Even this number appears to be much less than adequate for a country like India.

It is high time that the Government creates a conducive environment for increased penetration of health insurance within the country through innovative policy measures. One such measure could be by making health insurance cover mandatory for all employers, who provide provident fund facilities to their employees.

Conclusion:
It is a pity that the concept of health insurance has not properly taken off in our country, as yet, though shows immense growth potential in the years to come. Innovative policies of the government towards this direction along with increasing the cap on Foreign Direct Investment (FDI) for health insurance will encourage many competent and successful global players to enter into this market.

With the entry of efficient and successful global players in health insurance segment, one can expect to see many innovative insurance products to satisfy the needs of a large section of Indian population. Such an environment will also help increasing the retail distribution network of health insurance with a wider geographic reach, significantly improving the affordability and access to healthcare in general and medicines in particular, of a large number of population of the country.

By Tapan 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.

The need for urgent healthcare reform in India: The way forward.

Posted on by
Reply
If we look at the history of development of the developed countries of the world, we shall see that all of them had invested and even now are investing to improve the social framework of the country where education and health get the top priority. Continuous reform measures in these two key areas of any nation, have proved to be the key drivers of their economic growth.Very recently we have witnessed some major reform measures in the area of ‘primary education’ in India. The right to primary education has now been made a fundamental right of every citizen of the country, through a constitutional amendment.As focus on education is very important to realize the economic potential of any nation, so is the healthcare space of the country. India will not be able to realize its dream to be one of the economic superpowers of the world without sharp focus and significant resource allocation in these two areas.

Healthcare in India:

There are various hurdles though to address the healthcare issues of the country effectively, but these are not definitely insurmountable. National Rural health Mission is indeed an admirable scheme announced by the Government. However, many feel that poor governance will not be able make this scheme to become as effective as it should be. Implementation of such schemes warrants effective leadership at all levels of implementation. Similar apprehensions can be extended to many other healthcare initiatives including the health insurance program for below the poverty line (BPL) population of the country.

A quick snapshot on the overall healthcare system of India:

In terms of concept, India has a universal healthcare system where health is primarily a state subject.

Primary Health Centres (PHCs) located in the cities, districts or rural areas provide medical treatment free of cost to the citizens of the country. The focus areas of these PHCs, as articulated by the government, are the treatment of common illnesses, immunization, malnutrition, pregnancy and child birth. For secondary or tertiary care, patients are referred to the state or district level hospitals.

The public healthcare delivery system is grossly inadequate and does not function with a very high degree of efficiency, though some of the government hospitals like, All India Institute of Medical Science (AIIMS) are among the best hospitals in India.

Most essential drugs, if available, are dispensed free of charge from the public hospitals/clinics.
Outpatient treatment facilities available in the government hospitals are either free or available at a nominal cost. In AIIMS an outpatient card is available at a nominal onetime fee and thereafter outpatient medical advice is free to the patient.

However, the cost of inpatient treatment in the public hospitals though significantly less than the private hospitals, depends on the economic condition of the patient and the type of facilities that the individual will require. The patients who are from below the poverty line (BPL) families are usually not required to pay the cost of treatment. Such costs are subsidized by the government.

However, in India only 35 percent of the population have access to affordable modern medicines. The healthcare facilities in the public sector are not only grossly inadequate, but also understaffed and underfinanced. As a result, whatever services are available in most of the public healthcare facilities, are of substandard quality to say the least, which compel patients to go for expensive private healthcare providers. Majority of the population of India cannot afford such high cost of private healthcare providers though of much better quality.

A recent report on healthcare in India:

A recent report published by McKinsey Quarterly , titled ‘A Healthier Future for India’, recommends, subsidising health care and insurance for the country’s poor people would be necessary to improve the healthcare system. To make the healthcare system of India work satisfactorily, the report also recommends, public-private partnership for better insurance coverage, widespread health education and better disease prevention.

The way forward:

In my view, the country should adopt a ten pronged approach towards a new healthcare reform process:

1. The government should assume the role of provider of preventive and primary healthcare across the nation.

2. At the same time, the government should play the role of enabler to create public-private partnership (PPP) projects for secondary and tertiary healthcare services at the state and district levels.

3. Through PPP a robust health insurance infrastructure needs to be put in place, very urgently.

4. These insurance companies will be empowered to negotiate all fees payable by the patients for getting their ailments treated including doctors/hospital fees and the cost of medicines, with the concerned persons/companies, with a key objective to ensure access to affordable high quality healthcare to all.

5. Create an independent regulatory body for healthcare services to regulate and monitor the operations of both public and private healthcare providers/institutions, including the health insurance sector.

6. Levy a ‘healthcare cess’ to all, for effective implementation of this new healthcare reform process.

7. Effectively manage the corpus thus generated to achieve the healthcare objectives of the nation through the healthcare services regulatory authority.

8. Make this regulatory authority accountable for ensuring access to affordable high quality healthcare services to the entire population of the country.

9. Make operations of such public healthcare services transparent to the civil society and cost-neutral to the government, through innovative pricing model based on economic status of an individual.

10. Allow independent private healthcare providers to make reasonable profit out of the investments made by them

By Tapan 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.

Improving ‘Access to Modern Medicines’ in India –Public Private Partnership (PPP) is the way forward.

Posted on by
Reply
Despite various measures being taken by the Government of India (GoI) from time to time, around 65% of Indian population are not having access to modern medicines. It appears, GoI is of the view that the reason for poor ‘access to modern medicines’ to a vast majority of our population is intimately linked to the issue of ‘affordability of medicines’.To make medicines affordable to the common man, the Government took a radical step in 1972 by passing a law to abolish products patent in India. The change in paradigm at that time, encouraged domestic pharmaceutical players to manufacture and market even those latest and innovative drugs, which were protected by patents, n many countries of the world. The new ball game enabled the domestic players to highly specialize in ‘reverse engineering’ and launch generic versions of most of the New Chemical Entities (NCEs)at a fraction of the innovators price, in India.This shift in Paradigm in 1972, catapulted the Indian domestic pharmaceutical industry to a newer orbit of success. India in that process, over a period of time, established itself as a major force to reckon with, in the generic pharmaceutical markets of the world. Currently, the domestic pharmaceutical industry in India caters to around one third of the global requirement of generic pharmaceuticals.

From 1972 to 2005 domestic Indian pharmaceutical companies focused on replicating all most all blockbuster drugs, like for example, major Cox2 inhibitors (Merck and Pfizer), Viagra and Lipitor (Pfizer) etc, to low price generic substitutes and that too just within a year or two from the date of first launch of these products in the developed markets of the world.

In 1972, the Market share of the Indian domestic companies, as a percentage to turnovers of the total pharmaceutical industry of India, was around 20%. During the era of ‘reverse engineering’, coupled with many top class manufacturing and marketing strategies, domestic Indian pharmaceutical players wheezed past their multinational (MNCs) counterparts in the race of market share, exactly reversing the situation in 2009.

‘Reverse engineering’ was one of the key growth drivers of domestic pharmaceutical industry during this period. In its absence, during post IPR regime, the growth rate of branded generic industry is not expected to be as spectacular. However, the low cost ‘essential medicines’ will continue to be produced and marketed in India in future, as well.

Be that as it may, from 1972 to 2005, India could produce and offer even the latest NCEs, at a fraction of their international price, to the Indian population. There were as many as 40 to over 60 generic versions of each successful blockbuster drug of the world, in India. Cut-throat competition was intense and still it is, which keeps the average price of such medicines well under control. To further tighten its grip over pharmaceutical products pricing, GoI imposed stringent price control and price monitoring mechanism simultaneously, which are in place even today. Despite competitive pricing pressure coupled with Government price control, over nearly four decades, with a key policy focus on ‘affordability of medicines’, why then ‘access to modern medicine’ remained abysmal for a vast majority of the population of India?

To address this vexing problem, Industry Associations reported to have suggested a policy shift towards public-private-partnership (PPP) model to the Ministry of Chemicals and fertilizers in 2006-07. At that time, the Associations seem to have offered that the Pharmaceutical Industry will supply to the GoI the essential medicines at 50% of their Maximum Retail Price (MRP), to cater to the need of the common man, especially those who are below the poverty line (BPL).

However, to make this proposal effective there is a fundamental need for the Government to quickly initiate significant ‘capacity building’ exercise, initially in our primary and then in the secondary healthcare value chain. Towards this direction, the Federation of Indian Chambers of Commerce and Industry (FICCI) reported to have suggested to the Government for an investment of around US$ 80 billion to create over 2 million hospital beds.

Frugal budget allocation (1.12%) of the GoI towards healthcare as % of GDP of the country, suggests that Government is gradually shifting its role in this very important area, primarily from healthcare provider to healthcare facilitator for the private sectors to develop it further. In such a scenario, it is imperative for the government to realize that the lack of even basic primary healthcare infrastructure, leave aside other incentives, impede effective penetration of private sectors into semi-urban and rural areas. PPP model should be worked out to address such issues, effectively.

I have highlighted the remedial measures to be taken to address this situation in my article, which can be read by clicking on the following link:

http://www.tapanray.in/profiles/blogs/65-of-indians-do-not-have

Over 70 percent of our population are located in rural India. A relatively recent study indicates that despite some major projects undertaken by the Governments, like National Rural Health Mission (NRHM), about 80 percent of doctors, 75 percent dispensaries and 60 percent of hospitals are located in urban India. Another recent initiative taken by the Department of Pharmaceuticals (DoP) called ‘Jan Aushadhi’ is also orientated towards urban and semi-urban India.

I had deliberated upon the ways to increase penetration of ‘Jan Aushadhi’ in rural India, in another article, which can be read by clicking on the following link:

http://www.tapanray.in/profiles/blogs/jan-aushadhi-medicines-for

The net result of such policy initiatives, denies over 65 percent of Indian rural population from having access to quality healthcare services. Such lack of focus on rural areas, perhaps will explain the reason why only 35 percent of Indian population is having access to modern medicines.

Instead of trying to find a solution for this alarming ‘access to medicines’ problem, by limiting focus mainly on the issue of ‘affordability’ of medicines, for several decades, the Government is doing a great disservice to the common man, mainly located in the rural and semi-urban India. It is now high time that the GoI analyzes the available data to address the root cause of poor healthcare delivery, infrastructure and almost total lack of healthcare financing for all strata of Indian society.

Let me hasten to add that in no way I am trying to say that ‘affordability of medicines’ is no issue in India. All I am saying is that an integrated approach towards the root causes will quite effectively take care of ‘affordability’ issue and NOT the vice versa.

Even a problem of such magnitude can be converted into an opportunity. India can certainly be made a global hub for quality and affordable healthcare services, flashes of which we see in medical tourism initiatives.

Therefore, to address the acute problem of ‘access to modern medicines’ to a vast majority of the Indian population, GOI should reach all out to attract significant private and even foreign direct investments (FDI) through innovative Private Public Partnership initiatives. A strong will to have an ‘out of box’ solution to this critical problem is the crying need of the hour.

By Tapan 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.

‘Orphan Drugs’ for ‘Orphan Diseases’ – is ‘Open Source Drug Discovery (OSDD)’ platform for discovery research the way forward?

Posted on by
Reply
To meet the unmet needs of common and dreaded diseases intensive R&D activities are being undertaken by the Pharmaceutical Industry, the world over. At the same time, a percentage of human population, however small, also suffers from some rare diseases, for which there are no approved medical treatments even in the twenty first century, for the rich and poor alike.These rare diseases are also termed as ‘orphan diseases’, which are often chronic, progressive, degenerative, life-threatening or disabling. Many patients suffering from such rare diseases are denied their right to get their ailments effectively treated.It is indeed heartening to note that European Organization for Rare Diseases (EURORDIS) and National Alliances announced February 29, 2008 as the first ‘Rare Disease day’. Thereafter, the last day of February has been designated as ‘Rare Disease Day’ worldwide to call attention to the public health issues associated with rare diseases, which have been reported to affect around 30 million patients around the world.

People with rare diseases remain a medically underserved population even in a developed country. We can then well imagine the plight of such patients in India. The ‘Rare Disease Day’ is intended to bring together the patients and families with rare diseases to discuss the need for greater awareness, more research, and better access to diagnosis and treatment. I am not sure how various authorities, including our Government, are deliberating on this healthcare issue.

People suffering from ‘orphan diseases’ often face huge challenges compared to more common diseases. These include delay in getting an accurate diagnosis, few treatment options and difficulty finding medical experts. Many such rare diseases have no approved treatment. Moreover, treatments for ‘orphan diseases’ tend to be in most cases more expensive than treatments for more common diseases.

This year, the “Rare Disease Day” will be observed in India also, on February 28, though these are not very much talked about in our country, nor is there any proper definition in place for such diseases, as yet.

The drugs meant for treating ‘orphan diseases’ have been very appropriately termed as ‘orphan drugs’, mainly due to commercial reasons, as such drugs will be used on much fewer patients with commensurate return on investments towards R&D. Thus spending expensive R&D resources toward such drugs may not make sound commercial sense.

To address this need, in 1983, the Orphan Drug Act was passed by the Congress in the USA to extend financial incentives for companies to develop treatments for rare diseases. Since then, nearly 330 ‘orphan drugs’ and biologics have been approved by the U.S. FDA, which estimates that from 11 to 14 million Americans would benefit from these ‘orphan drugs’. However, despite such commendable measures taken by the US FDA, around 15 million Americans still leave with such ‘orphan diseases’ for which there is no approved treatment.

It is interesting to note that some of these ‘orphan diseases’ are now being diagnosed in India, as well. As India takes rapid strides in medical science, more of such ‘orphan diseases’ are likely to be known in our country.

Thus the moot question is how does India address this issue with pro-active measures? In the USA, even by giving adequate financial incentives, this problem could not be effectively addressed for commercial reasons.

In my view, one of the ways to properly address this issue is to follow the model of our very own the Council of Scientific and Industrial Research (CSIR) for an ‘Open Source Drug Discovery’ (OSDD) program with global partnerships, wherever required. This initiative has been pioneered by the well known scientist and Director General of CSIR Dr. Samir Brahmachari. Andrew Witty, the CEO of GlaxoSmithKline also had mooted a similar idea in another context in not too distant past.

Therefore, to address the issue of ‘orphan diseases’, in my opinion, the OSDD model with partnerships between private, public and academia will not only prove to be a viable and more practical model to discover ‘orphan drugs’, but will also help India to effectively contribute to this important global issue – not just by observing the ‘Rare Diseases Day’ on February 28 or 29, each year.

By Tapan 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.

An integrated approach towards Public Private Partnership (PPP) initiatives to improve access to healthcare in India is the way forward.

Posted on by
Reply
Despite so much of stringent government control, debate and activism on the affordability of modern medicines in India, on the one hand, and the success of the government to make medicines available in the country at a price, which is cheaper than even Pakistan, Bangladesh and Sri Lanka, on the other, the fact still remains, about 65% of Indian population do not have access to affordable modern medicines, compared to 15% in China and 22% in Africa.The moot question therefore is, despite all these stringent price regulation measures by the government and prolonged public debates over nearly four decades or so to ensure better ‘affordability of medicines’, why then the situation on ‘access to modern medicines’has remained so abysmal to a vast majority of the population, in India?This, in my view, is mainly because; no single minister or ministry can now be held accountable by the civil society for such a dismal performance in the access to healthcare, in India.

Poor healthcare infrastructure:

As per the Government’s own estimate, India records:

1. A shortage of 4803 Primary Health Centres (PHC)

2. A shortage of 2653 Community Health Centres (CHC)

3. No large Public Hospitals in rural areas where over 70% of the populations live

4. Density of doctors in India is just 0.6 per 1000 population against 1.4 and 0.8 per 1000 population in China and Pakistan respectively, as reported by WHO.

The Government spending in India towards healthcare is just 1.1% of GDP, against 2% by China and 1.6% by Sri Lanka, as reported by the WHO.

Some good but sporadic public healthcare initiatives:

The government allocation of around US$ 2.3 billion for the National Rural Health Mission (NRHM), is a good initiative to bring about uniformity in quality of preventive and curative healthcare in rural areas across the country.
While hoping for the success of NRHM, inadequacy of the current rural healthcare infrastructure with about 80 percent of doctors, 75 percent dispensaries and 60 percent of hospitals located only in the urban India, may encourage skepticism.

Addressing the issue of improving access to healthcare:

While addressing the issue of improving access of healthcare, following three important ‘Public Private Partnership (PPP)’ initiatives would be most appropriate.

1. PPP to improve affordability:

To address this vexing problem, industry associations had jointly suggested a policy shift towards public-private-partnership (PPP) model to the government in 2006-07, instead of a stringent price control mechanism, which has not worked thus far to improve access of modern medicines, in India. Instead, the associations seemed to have suggested that the pharmaceutical industry will supply to the government the essential medicines at 50% of their Maximum Retail Price (MRP), to cater to the need of below the poverty line (BPL) families.

It is worth mentioning, many OPPI member companies like, Novartis, GSK, Pfizer, Sanofi-Aventis etc. have their own access to medicines programs in India.

Although the government did not respond to this proposal, to make it effective the ministry of health will require to quickly initiate significant ‘capacity building’ exercises, both in the primary and also in the secondary public healthcare facilities in the country. FICCI is reported to have suggested to the Government for an investment of around US$ 80 billion to create over 2 million hospital beds, for such capacity building exercises .

Frugal budget allocation by the government towards healthcare of the country, suggests that Government is gradually shifting its role in this very important area, primarily from healthcare provider to healthcare facilitator for the private sectors to develop it further. If it is so, it is imperative for the government to realize that the lack of even basic primary healthcare infrastructure, leave aside other incentives, impede effective penetration of private sectors into semi-urban and rural areas. Effective PPP model should be worked out to address such issues, without further delay.

2. PPP to leverage the strength of Information Technology (IT) to considerably neutralize the system weaknesses:

Excellence in ‘Information Technology’ (IT) is one of the well recognized strengths that India currently possesses. This strengths needs to be adequately leveraged through PPP to neutralize the above weaknesses. Harnessing IT strengths, especially in the areas of drug procurement and delivery processes, especially in remote places, could hone the healthcare delivery mechanism, immensely.

Another IT enabled technology that India can widely use across the nation to address rural healthcare issues is ‘‘Telemedicine’ for distant diagnosis and treatment of ailments. Required medicines for treatment could be made available to the patients through ‘Jan Aushadhi’ initiative of the Department of Pharmaceuticals (DoP), by utilising the Government controlled distribution outlets like, public distribution system (ration shops) and post offices, which are located even in far flung and remote villages of India.

3. PPP in healthcare financing for all:

Unlike many other countries, even as compared to China, over 72 percent of Indian population pay out of pocket to meet their healthcare expenses.

Out of a population of 1.3 billion in China, 250 million are covered by insurance; another 250 million are partially covered by insurance and balance 800 million are not covered by any insurance. Converse to this scenario, in India total number of population who may have some sort of healthcare financing coverage will be around 200 million with penetration of health insurance at just around 3.5% of the population. India is fast losing grounds to China mainly due to better response to healthcare infrastructure.

Even after leveraging IT for ‘Telemedicine’ and improving healthcare delivery processes, together with availability of low priced quality medicines from ‘Jan Aushadhi’ outlets, a robust healthcare financing model for all strata of society to make healthcare products/services affordable to a vast majority of the population, will remain an essential requirement for the country to address the issue of improving access to healthcare to all.

According to a survey done by National Sample Survey Organisation (NSSO), 40% of the people hospitalised in India borrow money or sell assets to cover their medical expenses. A large number of populations cannot afford to pay for the required treatment, at all.

Conclusion:

In my view an integrated approach for creating effective healthcare infrastructure throughout the country, leveraging IT in the entire healthcare space, appropriately structured ‘Health Insurance’ schemes for all strata of society ably supported by well spread out ‘Jan Aushadhi’ outlets even in far flung rural areas, deserve careful consideration by the Government.

A PPP model in all these three areas needs to be worked out in detail to address the pressing issue of improving ‘Access to Affordable Integrated Healthcare to ALL’.

By Tapan 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.