Tag Archives: Alternative

Time For Pharma To Leverage ‘The Break In The Clouds’

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A ‘break in the clouds’ is now clearly visible in the dark and overcast sky – witnessing a global havoc caused by the Coronavirus pandemic in the healthcare space – with its severe socioeconomic consequences. The name of the game to combat this gargantuan crisis in a heavily restricted environment with success, is adding ‘error-free speed’ in all aspects of the planned countermeasures.

This isn’t a very easy task, either. And certainly, is possible with well-integrated digital interventions. From this perspective, one can construe this situation as ‘break in the clouds’ that can be leveraged by pharma companies for digital transformation of their respective business operations.

It may also be interpreted as a blessing in disguise, because such transformation will empower the companies to take appropriate effective measures with speed. When effectively leveraged, such strategic steps will help pharma players in two ways. One, to contain the virus spread while ensuring access to care through business operations. And the second, will help propel the organization to move ahead, even within such a crisis. However, the ‘Digitalization’ process is multifaceted, having, at least two fundamental prerequisites. In this article, I shall focus on this strategic space.

Alternative ways to provide health care is fast gaining ground:

The product and service delivery models of pharma companies are generally built around the concept of physical presence of patients while consulting a doctor or other health care providers. However, Coronavirus pandemic has triggered some significant changes in this area. Let me illustrate this point with some contemporary references.

As the recent L.E.K paper – ‘COVID-19 and the Acceleration of Digital Health in APAC’ emphasized – ‘by sheer necessity, governments and regulators have also reduced the barriers to participation and uptake for remote engagement of consumers, enabling access to care despite social distancing measures,’ during the pandemic. Moreover, a technical guidance paper, published by the World Health Organization (W.H.O) on April 1, 2020 on strengthening health systems against COVID-19, also recognizes ‘telemedicine’ as an alternative model for delivery of care to ensure the continuous running of essential health care.

COVID-19 will take health system digitalization to a new level:

The above L.E.K paper also pointed out – in the days and months ahead, COVID-19 will accelerate the ‘digitalization’ of health systems to a new level. Especially when, healthcare stakeholders adopt a more urgent, no-holds-barred strategy to stem the rising tide of infections. L.E.K article predicted, the new ways of working and behaviors, forged and refined in the heat of battle against COVID-19, will not be easily put “back in the box.” Consequently, this increasingly digitalized reality will force a paradigm shift in the healthcare ecosystem, the paper concluded.

‘A virtually perfect solution’ to neutralize Covid-19 impact: 

Another paper - ‘Virtually Perfect? Telemedicine for Covid-19,’ published in the NEJM on April 30, 2020 wrote, disasters and pandemics pose unique challenges to health care delivery. It underscored, ‘Though telehealth will not solve them all, it’s well suited for scenarios in which infrastructure remains intact and clinicians are available to see patients.’ It also indicated, telemedicine may be a virtually perfect solution, particularly where such infrastructure is available.

‘Governments must reimagine healthcare delivery’:

That ‘Telemedicine can be a COVID-19 game-changer’ - both now, and in a post-pandemic world, was also articulated by another article, published by the World Economic Forum on May 13, 2020. It suggested: ‘Governments must reimagine healthcare delivery in the face of COVID-19.’

This is mainly because, hospitals and several other places where the COVID-19 battle is raging – have become risky places for both patients and healthcare workers. Although, several measures are being taken to limit transmission from such places, those are still ‘insufficient to stop overstretching of healthcare systems that were already overwhelmed before COVID-19,’ the article observed.

The good news is, in sync with the recommendation of the World Health Organization (W.H.O) for the use of telemedicine as an alternative model to boost clinical performance and optimize service delivery, India has also recognized its telemedicine facility. The Government finds it as ‘a blessing in disguise in time of Covid-19’ and has urged - ‘it’s already high time to recognize telemedicine as a mandatory technology for responding to the current pandemic.’

Health consumers started utilizing digital platforms during lockdown:

hanger, As I wrote in my article of April 27, 2020, being literally locked down at home, a good number of healthcare consumers in India, are utilizing innovative digital platforms, mostly for common illnesses or follow-up consultations, such as:

  • For medical consultation on digital platforms, e.g., Skype, Facetime etc.
  • Getting diagnostic tests done at home by requesting through digital apps,
  • Sending test reports to doctors digitally,
  • Getting doctor’s prescription through digital mode,
  • Ordering medicines through e-pharmacy apps by uploading prescriptions,
  • Getting medicines delivered at home after e-payment,
  • Repeating the same process whenever required.

I also mentioned there, the use of telemedicine in several different, unconventional formats, is also gaining momentum, signaling its greater potential in the years ahead. It seems a reality today, as strict compliance with ‘social distancing’ guidelines is one of the basic requirements of health safety for all.

Does pharma have any other prudent choice now to be effective?

Traditionally, health care industry almost in all countries, is structured on the model of in-person interactions between patients and their clinicians. As the article – ‘Covid-19 and Health Care’s Digital Revolution,’ published in the NEJM on June 04, 2020 wrote, ‘clinical workflows and economic incentives have largely been developed to support and reinforce a face-to-face model of care, resulting in the congregation of patients in emergency departments and waiting areas during this crisis.’

Realizing that this model of care contributes to the spread of the virus to uninfected individuals who are seeking evaluation, many health care consumers are now postponing the needed care or looking for a digital solution for common ailments, to begin with.

In this environment to be effective – pharma players don’t seem to have any other choice but to transform their business operations and scaling up operating systems with the power of digital technologies, as the article indicated. Although, some digital technologies, including telemedicine, have existed for decades, they have had poor penetration into the market for different considerations. But, it’s a transformed situation today, exhibiting a groundswell for the same.

Groundswell for digital transformation in pharma?

COVID-19 pandemic is creating a groundswell for an early digital transformation in the health care space where pharma industry plays a very critical role. If one observes carefully, it is not difficult to fathom the change in behavior and practices of health care consumers. Thus, it calls for commensurate changes in the operating models of the drug players, to keep the kettle boiling, at the very least.

Consequently, the need for integrated digital interventions, quite akin to ‘Zoom’ – replacing many long in-person meetings. Changes of such nature and significance won’t just come and go. These are here to stay to add speed, convenience and cost-effectiveness in business operations, even if Coronavirus disappears, eventually.

The shape and talent need of future organizations will be prompted by such changes, facilitated by digital technologies and Artificial Intelligence (AI). However, digital transformation isn’t just a ‘switch-on’ operation of drug companies, as and when they would wish. Moving towards this direction will call for an unbiased assessment of, at least two prerequisites, for each player.

Two important prerequisites:

As both personal lives and also the work lives of almost all professionals and entrepreneurs, along with the customer behavior, have metamorphosed significantly, commensurate changes need to be implemented in all these areas, urgently. One area where a quantum change has taken place almost unknowingly – mainly driven by the human instinct of survival in a crisis, is the use of various state-of-the-art digital platforms. These include, the way businesses and professionals interact with each other for productive engagements.

Many studies have unraveled this process, such as the one – ‘Seizing the moment in digital’, published in the eye for pharma on May 28, 2020. It underscores two critical prerequisites for any digital transformation of businesses. These are to assess – first, how compatible will this transformation be with the existing organization culture and the same of its top leadership.

If any barrier surfaces, the organization would need to ask, whether its business is ready for a commensurate cultural transformation to make it work productively. The second one is, the capability – it may not be just the technical capability – internal or outsourced to go digital, but more importantly, the capability to run the transformed business to fetch desired results.

Conclusion:

The world is still in the midst of a global crisis, triggered by the Coronavirus pandemic. It is quite far from even plateauing in India. As on July 5, 2020 morning, crossing half a million mark, the recorded Coronavirus cases in the country have reached 673,904 with 19,279 deaths. And its climb continues.

Thus, amid a virtually unfathomable Covid-19 crisis, it will be foolhardy to predict what will happen next. However, as one joins the dots of some significant development, a perceptible trend emerges through the break in the clouds. This is unlikely to vanish anytime soon, and is very likely to be a new normal. Many articles from various thought leaders, such as one of McKinsey Digital - ‘The COVID-19 recovery will be digital’, published on May 14, 2020, vindicated a ground swell for the same. Yet another interesting article of May 11, 2020, termed the Covid-19 pandemic as a black swan event – ‘pushing towards a digital future.’

That said, digital transformation for a drug player will call for an unbiased assessment of two critical prerequisites – culture and capability, to deliver a meaningful outcome. Be that as it may, all indicators confirm that this is undoubtedly a critical time for pharma to leverage the ‘break in the clouds’ in pursuit of excellence – in the new normal.

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.

The ‘TINA Factor’: A Hotspot for Patented Drugs

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An article published in a global business magazine on December 5, 2013 mentioned that Marijn Dekkers, the CEO of Bayer AG reportedly has said at the Financial Times Global Pharmaceutical & Biotech Conference held this month that:

“Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India but for Western Patients that can afford it.”

The head honcho deserves kudos for revealing his mind upfront, while inviting two quick questions, as follows:

  • If that is so, why did Bayer launch Nexavar in India?
  • Did Bayer have any other alternative or choice for not doing so, other than negotiating for a ‘Voluntary License’?

As Bayer already had decided against any ‘Voluntary License’ for Nexavar in India, the simple answer to both the questions is : There Is No Alternative (TINA). And…that’s my ‘TINA Factor’, now a hotspot for patented drugs in India.

I shall dwell on it below, just in a short while.

Bellicose stance for high drug prices and more stringent patent regime:

Everybody acknowledges, beyond even an iota of doubt, that the contribution of the global pharmaceutical industry in the ongoing fight of mankind against diseases of all kinds, is commendable and exemplary.

However, over a period of time, as the low hanging fruits of pharma R&D are in the process of getting all plucked, raw commerce mainly driven by likes of “The Wall Street” quarterly expectations, have started overriding public health considerations involving a large section of the society, across the world, including India.

In this evolving scenario, healthcare has to be extended to almost everybody in the society by the respective Governments in power with strong support from the pharma industry. Instead, to utter dismay of many, the later seems to have opted for a bellicose stance.  Their lobby groups appear to be power playing with all might in the corridors of power, to make the product patent regime of faster growing emerging markets more and more stringent, restricting smooth entry of affordable generic or biosimilar drugs increasingly difficult.

Underlying reasons for Big Pharma’s near obsession to have in place an ever stringent patent regime, defying all public health interest particularly of the developing countries, I reckon, are mainly three-fold:

  • Grant of product patent for any innovation irrespective of triviality
  • To have absolute pricing freedom for patented drugs for unlimited profits
  • To enjoy and extend product monopoly status as long as possible

Probably, to camouflage these intents, the reasons for high prices of patented drugs are attributed to the over-used buzz-words – fostering and re-investing in innovation, which is more often underscored as frightfully expensive.

Fair enough, in that case, let the high cost of R&D be appropriately quantified involving independent  experts and made known to public. It will then not be like a jig saw puzzle for people to understand the real intent or the truth behind high drug prices. Thereafter, practical solutions need be fleshed-out putting the bright brains and minds together to make new medicines affordable to patients, across the world.

Most probably, that is not to happen, unless a legally binding system of disclosure of expenses is made mandatory for R&D, just as the ‘Physician Payment Sunshine Act’ of the United States demands public disclosure of gifts and payments made to doctors by the pharma players and allied businesses.

On the contrary, incessant efforts by vested interests still continue to keep the patented drug prices beyond the reach of common man. The following are just some very recent examples:

Another ‘defiant move’ in drug pricing:

In another recent development, US-FDA on December 6, 2013 approved Sovaldi (sofosbuvir) of Gilead Sciences Inc. This new drug is reported to be a cure for chronic infection with hepatitis C virus, without co-administration of interferon.

According to the report of July 2013 of the World Health Organization (WHO), about 150 million people are chronically infected with hepatitis C virus, and more than 350, 000 people die every year from hepatitis C- related liver diseases, across the world.

Most interestingly, Gilead Sciences have reportedly decided to keep the price of Sovaldi at a staggering US$ 1,000 (Rs. 62,000) -a-day for one tablet to be continued for 12 weeks. Thus the cost of a three month course of treatment with Sovaldi would be a mind boggling sum of US$ 84,000 (Rs.L 5.21), just for one patient.

It is worth noting that the above price/table of Sovaldi, as decided by Gilead Sciences, has started culminating into a storm of protest, almost immediately, even in the United States (US). The biggest drug benefits manager in that country – Express Scripts Holding Co. in a decisive move to drive down spending on the medicines, reportedly plans to start a price war when Sovaldi comes to market next year or early in 2015 wearing a price tag of US$ 1,000 a pill.

Further, on this seemingly defiant pricing strategy, that too for a life saving drug affecting patients belonging to all strata of the society, ‘Doctors Without Borders’ have reportedly commented: “Using patents to block affordable versions of sofosbuvir and pricing this drug out of reach of the most vulnerable groups who need it most is simply putting profits before people’s lives.”

Brewing a fresh initiative for more stringent high drug price regime:

To foist stricter pharmaceutical patent regime, making access to affordable drugs for the world’s poor increasingly challenging, an initiative is reportedly brewing afresh led by the United States (US).

Ministers of Trade from 12 countries initiated a discussion on December 6, 2013 at Singapore to meet the US deadline of forging a deal on the proposed ‘Trans-Pacific-Partnership (TPP)’ before the end of 2013.

These twelve countries – Australia Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, USA and Vietnam, contributing 40 percent of the world economy, are expected to hammer out the TPP deal first, though other countries may hitch on thereafter.

However, after 4 days of intense negotiation, the US-led TPP talks ended on December 10, 2013, without beating into shape any deal. These countries would reportedly meet again on January 2014, in contrast to earlier plan.

The global human right groups like ‘Medicins Sans Frontieres (MSF)’ and ‘Doctors Without Borders’ have reportedly commented, “The ‘Data Protection’ period will prevent drug regulatory agencies in TPP signatory countries from referencing data needed to approve lower-cost generic versions of a protected drug, delaying competition that would lead to cheaper prices”.

In a poll commissioned by ‘Avaaz’ – a global advocacy group, reportedly 62 percent of Americans, 63 percent of Australians, 70 percent of New Zealanders, and of 75 percent Chileans opposed limiting access to generic medicines through the patent proposal in TPP.

Quite expectedly, the powerful US pharma lobby group ‘Pharmaceutical Research and Manufacturers of America (PhRMA)’ said, “It was necessary for companies to recover investments and conduct further research into new cures”.

Breath of fresh air:

The good news is that some prudent developments are also seen around in the midst of a monopolistic drug pricing scenario, offering a breath of fresh air. Some countries around the world, including an important payor in the Unites States, National Institute for Health and Care Excellence (NICE) of UK which assesses the value of drugs for NHS use, and even ‘National Development and Reform Commission (NDRC)’ of China, have now started taking note and proactive measures in different ways on monopolistic high drug prices.

A recent report highlighted that ‘National Development and Reform Commission (NDRC)’ of China would examine and regulate the price-related monopolistic practices of six industries operating in the country, including pharmaceuticals and would crack down wherever they find excessively high prices. 

Can India insulate itself from pricing onslaught?

Despite growing global pressure against ‘putting profits before people’s lives’, one may arguably expect more such initiatives spearheaded by Big Pharma to make the patent regime, of especially the emerging markets, more stringent in the years ahead.

That said, ‘The TINA Factor’, which I shall now dwell upon, would probably help reinforcing the protective shield of Indian patent regime against foreseeable assaults with strategies quite similar to as cited above, denying access to new life saving drugs to most of the general population of the country.

‘The TINA Factor’ and three ‘Alternatives’ available to MNCs:

Since enactment of patient-friendly patent laws by the Parliament of India effective January 1, 2005, many global pharma companies and their lobby groups have been continuously expressing immense displeasure and strong anger in many ways for obvious reasons, just as the CEO of Bayer AG did recently.

There are, of course, a few exceptions, such as Sir Andrew Witty, the global CEO of GlaxoSmithKline (GSK), who has been publicly expressing balanced views on this subject in several occasions, so far.

Being driven by anger and possibly desperation any MNC may wish to choose one of the following three ‘Alternatives’ available to them:

Alternative 1: Do not apply for the product patent in India at all.

‘The TINA Factor’: In that case the product will be made available in a platter for the generic players to copy.

Alternative 2: Obtaining the relevant patent from the Indian Patent Office (IPO), do not launch the patented product in India.

‘The TINA Factor’: After three years from the date of grant of patent, as per the statute, the said product could become a candidate for CL on the ground that the patented invention has not been worked in India.

Alternative 3: Launch the product only at the international price.

‘The TINA Factor’: If any patented new product is not available to patients at a ‘reasonably affordable price’ or ‘reasonable requirements’ of patients with respect to the patented invention are not satisfied, again according to statutes, interested parties are free to apply for CL to the IPO, following the steps as specified in the Act. Moreover, the Government itself may issue CL in national emergencies or ‘extreme urgency’ for non-commercial use.

Considering the ‘TINA Factor’, it appears, if the new products do not conform to the ‘Indian Patents Act’ and are NOT launched with ‘reasonably affordable prices’ or ‘reasonable requirements’ of patients are NOT met with these new drugs, the possibility of their legal generic entry at much lower prices is rather high in India. CL granted by the IPO for Bayer’s Nexavar to NATCO vindicates this point.

Summing-up effects of the ‘TINA Factor’:

Many would now reckon that the ‘TINA Factor’, being a hotspot for patented drugs in India, has the potential for getting adopted by many other countries in not too distant future. Two of its palpable effects, as felt in the country so far, may be summed-up as follows:

  • It leaves no option to any MNC, other than launching their new products in India, especially after obtaining  relevant patents from the IPO.
  • It also squashes apprehensions of many that discontented Big Pharma would be able stop launching patented new products in India, depriving a large number of patients of the country.

Conclusion:

‘The TINA Factor’, thus created by the lawmakers, is expected to remain undiluted, unless commensurate changes are made in the Indian Patents Act.

Not withstanding the reported anger expressed by the CEO of Bayer AG or recently reported ‘absurd pricing’ of Sovaldi, or even for that matter, fresh attempts that are now being made to cobble together a TPP deal, patented new products would continue to be launched in India, as they will receive marketing approval from the Drug Controller General of India (DCGI).

Any possibility of dilution of the ‘TINA Factor’ seems remote now, though powerful overseas pharma lobby groups are investing heavily for a change to take place in various ways.

It also does not seem likely, at least in the near to mid-term, that India would be a party to its ‘Patents Act’ diluting any ‘Free Trade Agreement’ or remain unmoved with high drug prices like, US$ 1000/tablet for life saving drugs like sofosbuvir, more so, if those are considered essential medicines in the country.

Come 2014, it appears improbable that any new Union Government would be able to garner enough numbers in the Parliament to amend Indian Patents Act, buckling under pressure of powerful lobby groups, directly or indirectly, and daring to ignore public sentiment on this sensitive issue. 

Considering all these, the point to ponder now:

While abhorring pro-patients ‘Patents Act’ of India, can the Big Pharma come out with any viable alternative today for NOT launching their life saving patented new drugs in the country with the ‘TINA Factor’ prevailing?

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.