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Digitization or Digitalization: What’s Seen More in Indian Pharma?

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Just before this New Year, a doctor friend from a large city of India invited me for dinner, as I happened to be there for a couple of days. Dr. Srikanth Kashikar (name changed) is one of my longtime friends, and a super specialist in the field of oncology.

As Srikanth planned to come for dinner straight from his clinic, I was keen to observe a few pharma  company representatives making professional calls to him, if possible. Srikanth agreed. as that was one of those days when he meets them, after seeing all his patients. 8 pm was the mutually agreed time.

I was there a little before the scheduled time. However, as Srikanth was still examining a patient, he came out and asked me to wait for a few minutes in his assistant’s room. Right around 8.15 pm I was in his office. He sent a message through his secretary that he won’t be able to see more than two representatives, as he needs to go out.

What I experienced?

Sometime back, I had a similar experience of sitting incognito in the clinic of another doctor friend, practising in another major city. Hence, I had a heightened level of interest in getting a ringside view of changes in the professional discourse, if any, especially involving the science and art of persuasive medical communication of the modern world.

Meanwhile, the first representative – a pleasant personality, and wearing a smile on his face, entered the room. As he greeted, my friend reciprocated with a brief smile. The young man was representing a large global pharma player. He seemed to be a bit nervous, though, probably apprehending the time constraint to do his job effectively.

I was delighted to see him taking out a tablet computer. He commenced detailing a complex oncology product, but apparently was going a bit faster than any normal communication process. Digitally captured impressive visuals, sound and medical references flashed in and out. It reminded me the age-old approach of Medical Representatives’ (MR) detailing from well-designed folders, printed on art cards.

Dr. Kashikar did not ask any question, neither during nor after the presentation. His face was rather expressionless – difficult to fathom what was going in his mind, at that time.  Nonetheless, having completed his detailing, the young MR explained the procedure for the patients to get his expensive cancer product at a concessional price. This also did not appear much novel to me, either. Requesting for prescription support, the young man left the clinic, a bit hurriedly, though.

The second MR came in, accompanied by a not so young gentleman, whom he introduced as a manager. They were from a large Indian company. As the MR was about to take his detailing aid out, my doctor friend asked him to make his presentation brief. This apparently unsettled the person. Highlighting just a few points for different products from his folder, he requested the doctor to prescribe a particular oncology brand, and looked at the manager. At that stage, his manager took out a tablet PC demonstrating a product price comparison chart, and also the results of some local clinical trials that his company has conducted on the product. My friend shifted his posture on the chair several times till the manager was done with his presentation.

After they left, I looked at my friend, as he looked at me. He smiled, and said let’s go. I did not enquire anything about the two just concluded calls, either. Thereafter, it was purely laughter and fun between two of us and our wives, as we all were catching up with each other.

My overall impression?

My impression? These will obviously be based on just two interactions, involving some big pharma names, though. It appeared to me, top and busy doctors, such as my friend, continue remaining mostly passive during product detailing. MRs usually switch into a mode of hurry, when asked for making a brief presentation by the specialists, just as what was happening in the past.

The only visible change, I guess, is in a few areas of digitization of detailing tools. I hope, considerable time-gap between my two such experiences, was filled-up by expensive external and internal training inputs of all kinds, including digitization in some areas. Thus, the moot question that surfaces: Are these training programs significantly improving per field staff average productivity on the ground?  In case the answer is ‘no’, there arises an urgency to know ‘why’ and what is the way forward?

Zeroing-in:

The answer to the above question of productivity would entail an enormous amount of data to analyze, which I don’t have access to, right now. Nonetheless, as an illustration, let me zero-in on to just one change that I noticed on that day –  the use of tablet computer during field staff interaction with the doctors. This brings me to the subject of today’s discussion – ‘Digitization or Digitalization: What’s Seen More in Indian Pharma?’ In this article, I shall deliberate on this fascinating area during the changing phase of pharma business dynamics.

More of ‘Digitization’ or ‘Digitalization’?

Both ‘Digitization’ and ‘Digitalization’ are important, and often used as interchangeable words. Although, these two are significantly different, it’s not possible to bring in a digital transformation in business sans digitization.

A.   Digitization:

Digitization basically means automation of currently followed manual systems, records and processes, from analog to digital formats. These cover different types of paperwork or paper-based information systems, including photos or sound or even movement. The simplest example of this is scanning a paper document or photograph and storing them as soft copies, or even converting a movie from a celluloid format to DVD.

Digitization in context of pharma:

In the pharma industry, it may mean converting a detailing folder into digital format and delivering a similar product message to the medical profession through a tablet computer. It may also include field staff reporting system or customer call planning, replacing the manual ones, among many others.

The changes that digitization may ensure are generally incremental in nature. It can help doing many routines much easier, at a lesser cost and in lesser time, facilitating business activities and operations. However, just as any other industry, digitization is unlikely to fetch any fundamental transformation – or help taking a quantum leap in productivity or overall effectiveness of a pharma business, as well.

B.   Digitalization:

Digitalization is defined as the use of digital technologies to change business models and provide new revenue generating opportunities with significant value-creation. It is, therefore, the process of moving a business into the digital world. Similarly, in pharma business ‘Digitalization’ or digital transformation can be achieved by digitalizing everything that can be digitized through integration of digital technologies in different platforms to create and deliver game changing values to patients and other stakeholders.

Interactive question and answer of ‘Siri’ – built into iPhone of Apple Inc. is an important example of digitalization – going way beyond digitization. Another interesting example of digitalizing business, creating path breaking values, can be drawn from the entertainment space – e.g. film and television industry. These businesses offer streaming or downloading facility for movies or TV-serials to viewers, anywhere at any time, at a reasonable price. A few important examples in this area may include, Netflix, Amazon Prime or Hotstar. For digitization, an equivalent example, as I said before, could be DVDs.

In fact, one of the largest vendors of Enterprise Resource Planning (ERP) software and related enterprise applications – SAP made an interesting statement in this regard. It said, having done digitization for many decades, which has immensely increased the efficiency of its processes, SAP is now on its way to digitalization.

Digitalization in context of pharma:

The May 30, 2017 article on ‘Pharma Digitalization’, published in the European Pharmaceutical Review (EPR) says pharma business is undergoing a concurrent transformation on multiple, unrelated areas changing the whole product lifecycle from early drug development to manufacturing and patient care.

Consequently, improving patient outcomes is becoming a key challenge for the pharma companies. Garnering capability to provide real-time information about the disease condition to patients, and collecting patient data for care analytics to improve the treatment process, are emerging as critical ingredients for quantum value addition to pharma business.

Digitalization of business processes with integrated technology can help pharma players to address several major patient care challenges. These may include good compliance to treatment and effective chronic disease management, which can also help them to create hundreds of billions of dollars in value.

Reading the writing on the wall clearly, some pharma giants, like Novartis, GSK and Novo Nordisk have started investing in partnerships and new business models with technology companies, such as Google, IBM and Qualcomm. Even the traditional device manufacturers – Apple, Samsung and Nokia are now researching beyond the wellness products, looking to the patient care market. All this will substantially improve the patient care processes, where the patient care data will become the new source of innovation and competitiveness.

Likewise, digitalization of pharma sales and marketing would entail transformative value creation through integrated digital technologies in all the related functions. As stated above, it should reach right up to the patient and other stakeholder needs, meeting expectations in effective prevention, management and treatment of a a plethora of disease conditions.

Conclusion:

To effectively compete and be winners in the new paradigm, Indian pharma players will necessarily need to step out of the comfort zone. Venturing into the complex world of digital transformative processes will eventually become an essential quality – not just for excellence, but survival too. This is a highly specialized area of qualified experts, both for training and hand-holding.

The clock has started ticking for pharma CEOs to lead from the front. In tandem, they would require empowering a team of the right people with hands-on experience, expertise and passion. The team should ideally consist of individuals, both from within and outside the organization. Their only mandate should be to translate the digital transformation of the organization into reality, with quantum value creation, within a given time-frame.

The choice is, therefore, not between digitization and digitalization, regardless of their often use as interchangeable words. The meaning of each is significantly different, which needs to be properly understood. Although, ‘Digitization’ is more visible in the Indian pharma industry than ‘Digitalization’, as on date, this is also a reality that ushering in digital transformation in any business, such as pharma, is not possible sans digitization – but one should not stop there.

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.

Collaborative commercialization of inexpensive smaller incremental innovation in Chemistry will play an important role in bringing affordable new drugs or new drug delivery systems

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It started in the 17th century:

Alchemy, a medieval chemical science and speculative philosophy aiming to achieve the transmutation of the base metals into gold, searching for a universal cure for disease and indefinitely prolonging life, not considered a science by many, gradually became the basis for the development of chemistry into the 17th century. However, perceivable impact of chemistry on humanity, through its smaller incremental innovation, started being felt only in the second half of the 19th century.

Chemistry – an interface between the physical world and humanity:

Experts in this field often opine that the current form of human civilization has been made possible, to a great extent, through significant advancement of such innovation in chemistry and its role in modern technology. Chemistry is indeed an interface between the physical world on the one hand and the humanity on the other.

Getting a perspective of resource and time requirements for such initiatives:

Is there any similarity between development of pharmaceutical chemistry and IT software?

Now a days, one finds a striking similarity between small incremental innovation in IT software and the same in pharmaceutical chemistry. Both are creative and belong to the knowledge economy. Scientists in both the communities try to generate innovative ideas, which can lead to their effective commercialization.

Resource requirements for these two are strikingly different:

However, the nature of the commercialization process of these two sciences, though seemingly similar in terms of innovativeness, is indeed quite different. In the software community, two people can implement an idea with minimal resource requirement and could end up with a profitable commercialized product, without much difficulty. In contrast, two chemists may come up with a brilliant idea, which in many cases, may require significant investment of resources much before to even think to get the initial product commercialized. Subsequent steps of scaling up will be a separate issue altogether, with more resource commitment.

The process of commercialization of smaller incremental innovation in pharmaceutical chemistry is much longer:

As we all know, the process of commercialization of incremental innovation in chemistry takes a much longer time scale, as these are not usually spare time projects, unlike computer softwares. The cost involved in testing out and implementing a new idea in chemistry is very high and may not even be possible without any robust institutional backing.

Target inexpensive smaller incremental innovation in pharmaceutical chemistry:

Some illustrative examples of such smaller incremental innovation in chemistry are as follows:

1. Development of pharmaceutical co-crystals

2. Merger of chemistry of traditional and modern medicines for synergy in both efficacy and safety

3. Chemical technology switch: taking technology of one field and transferring it to a different field to get a new drug substance

4. Application of polymorphic chemistry in drug discovery.

The process has begun:

International experience:

The chemistry department of Oxford University, U.K, which is incidentally the biggest chemistry department of the western world, has made significant advances in commercializing incremental innovation in chemistry. Among many, they created and commercialized the following three entities through such incremental innovation:

• Medisense

• Oxford Molecular

• Oxford Assymetry

The Indian experience:

Despite all challenges, in India, as well, the commercialization process of smaller incremental innovation in chemistry has already begun. The Chemistry Department of the University of Delhi has developed 11 patentable technologies for improved drug delivery system using nano-particles. One of such technologies was development of ‘smart’ hydrogel nano-particles for encapsulating water-soluble drugs. This technology was sold to Dabur Research Foundation in 1999.

Another nano-particle drug delivery technology in opthalmogy area was also commercialized by transferring it to Chandigarh based Panacea Biotech Ltd.

Conclusion:

This process is expected to gain momentum in our country too, contributing significantly to the progress of the healthcare sector of the nation. “Commercializing smaller incremental innovation in Pharmaceutical Chemistry”, I reckon, will play a key role in providing affordable modern medicines to a vast majority of the population, as India transforms itself into a knowledge superpower.

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.

Increasing penetration of Health Insurance: an important way to improve affordability and access to healthcare

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While India is making rapid strides in its economic growth, the country is increasingly facing constraints in providing healthcare benefits to a vast majority of its population. This is mainly because of the following reasons:1. Inadequate healthcare infrastructure and delivery system2. Lack of proper healthcare financing/insurance system for all strata of society

3. Difficulty in managing costs of healthcare even when the country is producing drugs for the world market

In this article I shall touch upon only on the healthcare financing/insurance part of the problem.

Sporadic initiatives:

We find some sporadic initiatives 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 are being taken by the state governments:

1. The Government of Andhra Pradesh is planning 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. In fact, some private health insurers like Reliance General Insurance and ICICI Lombard General Insurance were reported to have won some projects on health insurance from various state governments.

Cost of healthcare is rising but the penetration of health insurance is still very poor:

All over India costs of all types of healthcare be it primary, secondary or tertiary, are going beyond the reach of common man. Even in rural India penetration of such schemes is almost as poor as the organized health insurance schemes available in urban India. In a situation like this one will need to ponder why the penetration of health insurance and micro health insurance is so low in our country covering just around 35 to 40 million of the population.

Government spend on health is too low:

Even today the Government spends just 1.2% of GDP on health. When both public and private sectors expenditures are put together this number works out to not more than 5%.

It has been reported that in 2005-06 the total private expenditure towards healthcare was around Rs 1, 35,000 crore. This number is expected to grow at a 5-year CAGR of around 16%.

High ‘out of pocket’ expenditure towards healthcare:

Currently around 78% of healthcare expenditure is ‘out of pocket’ and without any health insurance cover. A recent survey of the National Survey Organization has reported that around 40% of the people who get admitted to hospitals for treatment go through extreme financial hardship and many a times are compelled to abandon the treatment or need to sell of their property to meet such unavoidable expenditure towards health.

Disease pattern undergoing a shift increasing healthcare expenditure:

As the disease pattern is undergoing a shift from acute to non-infectious chronic illness, the cost of treatment is becoming even more. In a situation like this there is an urgent need to have a robust healthcare financing system within the country.

Covering domiciliary treatment through health insurance is important:

Currently heath insurance schemes only 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 at 50% and according to PHD Chamber of Commerce and Industry 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 some innovative policy measures. One such measure could be to make it mandatory for all employers, who are required to provide provident fund facilities to their employees to also offer health insurance facilities to all of them.

It is a pity that the concept of health insurance has not taken off in our country, as yet, though has immense growth potential in the years to come. Innovative policy measures 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 successful global players in health insurance segment, one can expect to see many innovative insurance products to satisfy the need of a large number of Indian population in the healthcare space. Such measures will also help increasing their retail distribution network with a wide geographic reach, significantly improving the affordability and access to healthcare 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.

Patent Linkage: an important step yet to be taken by the Government of India for proper enforcement of product patents granted in the country

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The process of Patent Linkage establishes a desirable communication process between the Health Ministry and the Patent Offices to prevent marketing approval of generic drugs before expiration of patents granted in India. It also ensures that one Government Department / Ministry does not impair the efforts of another Government Department / Ministry to provide effective intellectual property protection as required by Article 28 of the WTO TRIPS Agreement.
The system of Patent Linkage exists around the world:Following are some examples:

Australia – Health Authorities do not provide marketing approval for a generic copy which would infringe an existing patent.

Brazil – As of 2006, no copies of products still under patent have been launched in the market place. However, the Brazilian Health Agency (ANVISA), grants registration to copy products, based only on the merits of the case from the regulatory point of view, whether or not a patent has been granted for the same.

Canada – Health Regulatory Authorities do not provide marketing approval for pharmaceutical products protected by patents listed in the equivalent of the US FDA Orange Book.

China – The State Food & Drugs Administration (SFDA) must be satisfied that no patent is being infringed before it will issue marketing approval. If there has been litigation over a patent, SFDA will wait until the appeals process has been exhausted before acting.

Jordan – Marketing approval for a pharmaceutical product is not permitted during the period of patent protection.

Mexico – Applicants seeking marketing approval for generic pharmaceutical products in Mexico must certify that their patent rights are not infringed. The Health Regulatory Authorities then check with the Patent Office, which must respond within ten days to confirm whether a patent is involved. While Health Authorities will accept an application of marketing approval during the patent period, grant of marketing approval will be delayed until the patent expires.

Singapore – Applicants seeking marketing approval for generic pharmaceutical products in Singapore must declare that the application does not infringe any patent.

U.A.E – The Health Regulatory Authorities do not provide marketing approval for pharmaceutical products that remain under patent protection in the country.

U.S.A – U.S. FDA maintains a listing of pharmaceutical products known as the Orange Book. The Electronic Orange Book is also available via the internet at: http://ww.fda.gov/cder/ob The U.S. FDA does not authorize the marketing approval for a generic copy of a pharmaceutical product protected by a patent listed in the Orange Book.

Europe – Instead of Patent Linkage, the period of data exclusivity is for 10/11 years.

The Patent Linkage System is in progress in countries like Bahrain, Chile, Dominican Republic – Central America FTA (DR-CAFTA), Morocco and Oman.

Some people question why should India follow Patent Linkage system in the regulatory approval process?

In India ground realities in the patent enforcement process are quite unique. Thus there is an urgent need for having a Patent Linkage system in place for the following reasons:

1. The Government is granting product patent to encourage, protect and reward innovation in India, it will not be in the best interest of the innovators if the same Government grants marketing approval for a generic equivalent of the patented molecule during the patent life of the product.

2. Unlike many other countries, the Indian Patent Law has provision for both pre-grant and post-grant oppositions. Therefore, if anyone wants to challenge the patent, enough time will be available for the same.

3. After patent is granted for a product in India, if marketing approval is given to a generic equivalent of the same molecule, a dispute or patent infringement may arise. As per the Patents Act 2005, such disputes regarding patent infringement have to be challenged in a High Court. The judicial process is a long drawn one and it is quite possible that the patent life of the concerned molecule would expire during the dispute settlement period, which in turn, would raise doubts about the sanctity of granting a product patent to an innovator in our country.

Conclusions:

I therefore submit the following recommendations to ensure proper enforcement of products patent in India:

 The status of the grant of patent should be reviewed, through appropriate drug regulatory mechanism, before granting marketing permission to generic formulations and if the concerned innovative product is already patented in India, marketing permission for the generic formulation should be withheld.

 Appropriate mechanism/system should soon be worked out in co-ordination with other Ministries to avoid cases of infringement of product patents in India.

 The procedure (Patent Linkage) of checking the patent status of a product before granting marketing approval already exists in the Form 44. This procedure needs to be implemented.

India has instances where marketing permission has been granted by the DCGI for a generic product even when a product patent already exists for the same molecule in India. Such instances put the patent holder in a hardship and avoidable litigation involving huge resources both in terms of time and money. Situation like this can be effectively avoided by ascertaining the patent status before granting marketing permission to a generic manufacturer through an appropriate drug regulatory system, as indicated above.

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.