Tag Archives: apprehensive

Pharma: Experts’ Handholding is Pivotal in Digital Marketing Transition Phase

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“Pilman – A Tapan Ray Website on Helathcare” completes 10 years, today. 

Inspired by some of my dear friends, I created this website on January 14, 2009. Since then, reasonably well-researched articles, penned by me, on various aspects of health care, and the pharma industry, appeared in this blog – on every Monday morning of every week – uninterrupted – not even once. It did not just happen, I took a vow to make it happen with the same zeal, consistency and frequency, in the first 10 years of its launch – come what may. 

During this period, I have been humbled by tens of thousands of my dear readers, from all over the world, who went through these articles –  spending their valuable time. Today, with all humility, I bow my head before each of my readers to make it happen. After Ten years – a time has now come for me to decide what next. Thank you so much, from the very core of my heart.

Talking about digital marketing in pharma is virtually a fad now. It sounds so modern, sleek and is a great attention getter, especially in the tradition bound pharma industry. Advertisements of umpteen number of training programs are spilling all over. Even those who never worked with digital marketing in pharma, or possess any basic theoretical knowledge in this technology, are jumping into the fray. Some trainers claim to impart subject knowledge in the pharma domain, while others assert facilitating quick implementation of digital marketing by pharma executives.

Thus, the question that follows, why is the sudden interest in digital marketing for pharma by such trainers? What is happening in reality after these trainings? Is one blind man trying to help another blind man in this area, or it is a competition for sheer eyeball grabbing? Some friends in the industry do say, the common thread of ‘imparting training’ of this nature on digital marketing – outside any pharma company, is possibly the intent of ‘making a quick buck, while the sun shines.’

To me, this sounds too blunt a statement, as I reckon, expression of such a view will be unfair to formally qualified digital experts with proven experience of success in the pharma domain. Some of them also offer handholding young marketing professionals, with reasonable accountability, as they gradually transition from the traditional pharma to an integrated digital marketing model. In this article, I shall focus on this area by affirming, while digital softwares, tools and their applications aren’t anything new in pharma, making an integrated digital marketing process work effectively, is indeed a new necessity in the industry.

Digital tools and applications aren’t new in pharma: 

As I said, digital tools and applications aren’t new in pharma. For example, many Indian companies have already implemented likes of ‘Enterprise resource planning (ERP)’. This is basically an integrated business process management software that enables the organization to run their business processes, including finance, accounting, supply chain, sales, manufacturing and human resources, in an integrated environment. Some companies have also introduced field-staff reporting in digital format and online. Nevertheless, digital marketing in pharma being a new necessity, let me elaborate below what is digital marketing, and what it is not.

What is digital marketing and what it is not:

As defined by The Financial Times Lexicon, digital marketing is:

  • Marketing of products or services using digital channels to reach consumers. The key objective is to promote brands through various forms of digital media.
  • Digital marketing extends beyond internet marketing to include channels that do not require the use of the internet. It includes mobile phones, social media marketing, display advertising, search engine marketing, and any other form of digital media. 

And what digital marketing is not:

  • Digital marketing is not just yet another channel for marketing It requires a new approach to marketing and a new understanding of customer behavior.  

Pharma’s transitioning to integrated digital marketing is critical:

There isn’t any doubt today that transitioning into an integrated digital marketing for pharma is critical.

The paper titled, ‘Time for Pharma to Dive into Digital – New Medicine for a New World,’ published by AT Kearney advises drug companies to act now or get left behind. The paper makes some interesting observations to drive home this point, some of which are as follows:

  • Digital is changing the way healthcare is delivered, as pharma customers transitioning fast into the digital world.
  • Effective customer engagement in cyberspace with digital tools will increase customer reach, lower costs, improve sales, and enable greater value creation.
  • Necessary technologies are readily available for digital customer management in a cost-effective way.
  • Regulation, while not fully resolved, is becoming clearer.
  • Reduced effectiveness of traditional promotional expenditure makes the transition to digital marketing both critical and timely.
  • Digital disruption has rejuvenated many businesses. It is time for pharma to do the same.

In reality, many traditional pharma companies are still apprehensive:

Digital marketing sounds great. There isn’t an iota of doubt, either, that this new ball game help achieve many business goals with precision, in the complexity of pharma sales and marketing. When conceptualized and implemented creatively with hands-on involvement of both digital and pharma domain experts, its benefits could be exponential, instead of being incremental. All strategic business communication can be accurately targeted and delivered to precise stakeholders for better, faster and quality engagement, yielding desired outcomes.

Nevertheless, the reality is, as I sense through my direct interaction with pharma friends, many of them are still apprehensive of imbibing an integrated digital marketing, going whole hog. They carry ‘a fear of failure’, if… the initiative doesn’t work, for various reasons. Moreover, any possibility that they may even lose what they currently have for such disruptive measures, makes them quite edgy, as well.

Is the apprehension totally unfounded?

As I fathom, the answer is no. They have a genuine reason to think so, because they carry the can and prefer to avoid any kind of possible risk in the performance of their respective business. They may not be totally happy with the traditional model with decline productivity. But are not also willing to make any unfamiliar drastic change by replacing the traditional marketing model by a cohesive digital one, spanning across the organization.

Nether, do they want to take any such decisions where the requirement of employee competency for success will call for a drastic overhaul, which is understandable. Be that as it may, their feelings and the associated views can’t be brushed aside, either, – as they have been at the helm of pharma business with envious track records, since long.

Precise process, timing and the end-goal of digital marketing needs clarity: 

Interestingly, they all understand and agree that the transition from traditional to digital pharma marketing is inevitable. But they are not very sure about when should this transition commence for the India pharma business. Also, what are the sequential steps for the organization to move in this direction with least risk and chaos.

Many of them are also not quite clear of the end-goal of this process, which I think should go beyond offering just good drugs with unique features and benefits, to creating a unique full-service patient experience, with cutting-edge and ethical sales and marketing practices.

When to commence and where to start?

The following two pertinent questions that often arise need to be deliberated before a digital marketing initiative is undertaken by a pharma company:

  • When does a company to commence digital marketing?
  • Where to start with minimal risk exposure?

When to commence it?

Now – is the obvious answer. This is because, as I wrote in my article of June 11, with increasing number of pharma stakeholders using and interacting in the digital space, ‘consumerism’ is fast becoming a strong prime mover, even in the pharma industry. In tandem, patients’ longing for better participative treatment experience, at affordable cost, is turning into a major disruptive force in the healthcare space.Pharma players in the country, require to be on the same page, soon, to deliver sustainable results, before it’s too late.

Where does the transition from traditional to digital marketing start?

The answer will depend on marketing practices followed in a particular company, which digital experts will study and come out with an organization-specific action plan. Whosoever is the initiator of the project, the company CEO should be the final decision maker, with his total involvement in the project, for multiple reasons.

However, in my view, for those who are risk averse, it will be prudent to demonstrate that important marketing strategy when executed on integrated digital platforms, pay handsome dividend. Thus, I reckon, instead of replacing all traditional practices with a totally new and harmonized digital model, in one go, it may be better to add new marketing activities on digital platforms – having the potential to add significant value to the business, for example:

  • Capture and analyze useful information from various sources and functions within the organization, as inputs for marketing strategy formulation, by using state of the art digital tools and analytics.
  • Select those areas of sales and marketing where switching over to digital mode will add speed to the operation and the decision-making process. In any case there should be a parallel run of the traditional process and the digital one, for a pre-fixed time frame, to tighten the loose knots, if any.
  • Trying out social media under expert guidance. When used in innovative ways, it helps immensely to actively engage with targeted stakeholders, including patients, for getting a positive digital ‘word of mouth,’ besides important feedbacks.
  • Using mobile-friendly, well-targeted emails or text messages with useful, well-researched content eliciting response, either as feedbacks on selected business activities or on any other area useful for the business operation.

When ready for digital transformation across all functions of the organization, the CEO should solicit help of well-qualified professional digital experts, preferably from within the organization. If adequate resources are not available internally, experts in digital technology with a proven track record of success may be engaged from outside, equipped with high-quality pharma domain knowledge.

Conclusion:

As I said, digital interventions are not new in pharma. However, a well-harmonized digital marketing is. There could be many starting points for the transition from traditional to digital marketing. However, I reckon, low-risk initiatives to this direction – having the potential to add significant value to the business, would be prudent to start with.

Thereafter, the new and robust digital marketing platform – well-coordinated with all functions, need to necessarily undergo parallel pilot runs. The objective is to resolve the glitches in the new digital system, if any, minimizing business risks. The awareness and the need of digital marketing should preferably generate and be felt from within the organization. The trigger factor may be many, including the professional digital experts recently recruited or the CEO himself, who will decide how to cascade it down the line for effective implementation.

The name of the game is making the concept of digital marketing work effectively in the marketplace – separating the men from the boys, in the midst of cut-throat competition within the pharma industry. To take this giant leap, mere lip-services of external general advisors won’t be enough, and may not work, at all. This process requires a new approach to drug marketing digitally, involving a thorough understanding of patients’ and other stakeholders’ behavior. More importantly, in the transition phase of its implementation, handholding by high quality professional digital experts, ably supported by pharma domain experts, is pivotal for success.

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.

Patented Drugs’ Pricing: Apprehensive Voices Could Turn into a Self-Defeating Prophecy

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On February 21, 2013, the Department of Pharmaceuticals in a communication to the stakeholders announced that the committee to examine the issues of ‘Price Negotiations for Patented Drugs’ has since submitted its report to the Department. Simultaneously the stakeholders were requested to provide comments on the same urgently, latest by March 31, 2013.

This committee was constituted way back in 2007 to suggest a system that could be used for price negotiation of patented medicines and medical devices ‘before their marketing approval in India’.

In that process, the Committee reportedly had 20 meetings in two rounds, where the viewpoints of the Pharmaceutical Industry including FICCI, NGOs and other stakeholders were taken into consideration.

Simultaneously, the Committee had commissioned a study at the Rajiv Gandhi School of Intellectual Property Law and Indian Institute of Technology (IIT), Kharagpur to ascertain various mechanisms of price control of Patented Drugs in many countries, across the world. The Committee reportedly has considered this ‘Expert Report’ while finalizing its final submission to the Government.

Scope of recommendations:

The Committee in its final report recommends price negotiations for Patented Drugs only for:

  • The Government procurement/reimbursement
  • Health Insurance Coverage by Insurance Companies

Issues to remain unresolved despite price negotiation:

In the report, the Committee expressed the following view:

  • Even after calibrating the prices based on Gross National Income with Purchasing Power Parity of the countries where there are robust public health policies, with the governments having strong bargaining power in price negotiation, the prices of patented medicines will still remain unaffordable to a very large section of the population of India. Such countries were identified in the report as UK, Canada, France, Australia and New Zealand
  • The government should, therefore, extend Health Insurance Scheme covering all prescription medicines to all citizens of the country, who are not covered under any other insurance /reimbursement scheme.

Three categories of Patented Drugs identified:

The committee has identified three categories of patented drugs, as follows:

1. A totally new class of drug with no therapeutic equivalence

2. A drug that has therapeutic equivalence but also has a therapeutic edge over the  existing ones

3. A drug that has similar therapeutic effectiveness compared to the existing one

The Committee recommended that these three categories of Patented Drugs would require to be treated differently while fixing the price.

A bullish expectation of the Government on Patented Drugs market:

The report highlights that the Indian Pharmaceutical Industry has currently registered a turnover exceeding US$ 21 billion with the domestic turnover of over US$ 12 billion.

The report also estimates that the total value turnover of patented medicines in India, which is currently at around US$ 5 million, is expected to grow at a brisk pace due to the following reasons:

  • Rapid up-gradation of patent infrastructure over the past few years to support new patent laws with the addition of patent examiners.
  • Decentralization of patent-filing process and digitization of records.
  • Increase of population in the highest income group from present 10 million to 25 million in next 5 years.

All these, presumably have prompted the Government to come out with a ‘Patented Drugs Pricing’ mechanism in India.

Pricing Mechanism in China: 

Just to get a flavor of what is happening in the fast growing neighboring market in this regard, let us have a quick look at China.

In 2007, China introduced, the ‘New Medical Insurance Policy’ covering 86 percent of the total rural population. However, the benefits have so far been assessed as modest. This is mainly because the patients continue to incur a large amount out of pocket expenditure towards healthcare.

There does exist a reimbursement mechanism for listed medicines in China and drug prices are regulated there with the ‘Cost Plus Formula’.

China has the following systems for drug price control:

  • Direct price control and competitive tendering

In this process the Government directly sets the price of every drug included in the formulary. Pharmaceutical companies will require making a price application to the government for individual drug price approval.The retail prices of the drugs are made based on the wholesale price plus a constant rate.

Interestingly, unlike Europe, the markup between the retail and wholesale price is much higher in China.

Apex body for ‘Patented Drugs Price Negotiation’: 

The Report recommends a committee named as ‘Pricing Committee for Patented Drugs (PCPD)’ headed by the Chairman of National Pharmaceutical Pricing Authority (NPPA) to negotiate all prices of patented medicines.

As CGHS, Railways, Defense Services and other Public/Private institutions cover around 23 percent of total healthcare expenditure, the members of the committee could be invited from the Railways, DGHS, DCGI, Ministry of Finance and Representatives of top 5 health insurance companies in terms of number of beneficiaries.

Recommended pricing methodology:

For ‘Price Negotiation of Patented Drugs’, the report recommends following methodologies for each of the three categories, as mentioned earlier:

  1. For Medicines having no therapeutic equivalence in India:
  • The innovator company will submit to the PCPD the details of Government procurement prices in the UK, Canada, France, Australia and New Zealand for the respective Patented Drugs.
  • In the event of the concerned company not launching the said Patented Drug in any of those reference countries, the company will require to furnish the same details only for those countries where the product has been launched.
  • The PCPD will then take into consideration the ratio of the per capita income of a particular country to the per capita income of India.
  • The prices of the Patented Drug would be worked out for India by dividing the price of the medicine in a particular country by this ratio and the lowest of these prices would be taken for negotiation for further price reduction.
  • The same methodology would be applicable for medical devices also and all the patented medicines introduced in India after 2005.

2. For medicines having a therapeutic equivalent in India:

  • If a therapeutically equivalent medicine exists for the Patented Drug, with better or similar efficacy, PCPD may consider the treatment cost for the disease using the new drug and fix the Patented Drug price accordingly
  • PCPD may adopt the methodology of reference pricing as stated above to ensure that the cost of treatment of the Patented Drug does not increase as compared to the cost of treatment with existing equivalent medicine

3. For medicines introduced first time in India itself:

  • PCPD will fix the price of such drugs, which are new in the class and no therapeutic equivalence is available, by taking various factors into consideration like cost involved, risk factors and any other factors of relevance.
  • PCPD may discuss various input costs with the manufacturer asking for documented evidence.
  • This process may be complex. However, the report indicates, since the number of medicines discovered and developed in India will not be many, the number of such cases would also be limited.

Negotiated prices will be subjected to revision:

The report clearly indicates that ‘the prices of Patented drugs so fixed will be subjected to revision either periodically or if felt necessary by the manufacturer or the regulator as the case may be.’

Strong voices of support and apprehension:

A.  Support from the domestic Indian Pharmaceutical Industry

Interestingly there have emerged strong voices of support on this Government initiative from the domestic Indian Pharmaceutical Industry, as follows:

  • Indian Pharmaceutical Alliance (IPA) has commented, “This policy is in the right direction as we know that Compulsory License (CL) cannot address the need of price control for all patented drugs, so this policy takes care of that issue of a uniform regulation of price control for all patented drugs”. IPA had also suggested that the reference pricing should be from the developed countries like UK, Australia and New Zealand where the 80 percent of the expenditure being incurred on public health is borne and negotiated by the government.
  • Pharmexcil - another pharma association has commented, “This report is balanced and keeps India’s position in the global market in mind while recommending a pricing formula.”
  • Federation of Pharma Entrepreneurs (FOPE) & Confederation of Indian Pharmaceutical Industry (CIPI) had submitted their written views to the Committee stating that FOPE supports price negotiation mechanism for Patented Drugs and strongly recommends that Compulsory License (CL) provisions should not get diluted while going for price negotiation.
  • Indian Drug Manufacturer Association (IDMA) supported price negotiation for all Patented Drugs and recommended that the issue of CL and price negotiation should be dealt separately.

However, the Organization of Pharmaceutical Producers of India (OPPI) feels, as the report indicates, ‘Price Negotiations for Patented Products’ should be made only for Government purchases and not be linked with ‘Regulatory Approval’. They have already expressed their serious concern on the methodology of ‘Patented Products Pricing’, as detailed in the above report.

B. Apprehension within the Government

Even more interestingly, such apprehensive voices also pan around the Government Ministries.

Though the DoP has proposed in the report that once the Patented Drug Policy is implemented the issuance of CL may be done away with, the Department of Industrial Policy and Promotion (DIPP) has reportedly commented with grave caution, as under:

“If it is decided that Price Negotiations on Patented Drugs should be carried out then, the following issues must be ensured:

(i) Negotiations should be carried out with caution, as the case for Compulsory License on the ground of unaffordable pricing of drugs [Section 84(b) of the Patent Act] will get diluted.

(ii) Re-Negotiations of the prices at periodic intervals should be an integral part of the negotiation process.”

C. Apprehension of other stakeholders 

The NGOs like, “Lawyer’s Collective HIV/Aids Unit” and “Medicines Sans Frontiers (MSF)” reportedly have urged that the price negotiation should not be allowed to weaken the position of CL for the Patented Drugs.

They had mentioned to the Committee as follows:

“As regards the plea of the patent holder that they had spent a large sum on R&D, one should note that most of the funds for R&D come from the Governments of their respective countries”. They further stated, “when the cost of production of the patented drugs is not known, it would be impossible to negotiate the price in a proper manner.”

The DoP report states that the other members of the NGOs also seconded these views.

Conclusion:

Not so long ago, on January 12, 2013, one of the leading dailies of India first reported that in a move that is intended to benefit thousands of cancer patients, Indian Government has started the process of issuing Compulsory Licenses (CL) for three commonly used anti-cancer drugs:

-       Trastuzumab (or Herceptin, used for breast cancer),

-       Ixabepilone (used for chemotherapy)

-       Dasatinib (used to treat leukemia)

For a month’s treatment drugs like, Trastuzumab, Ixabepilone and Dasatinib reportedly cost on an average of US$ 3,000 – 4,500 or Rs 1.64 – 2.45 lakh for each patient in India.

I reckon, a robust mechanism of ‘Price Negotiation for Patented Drugs’ could well benefit the global pharmaceutical companies to put forth even a stronger argument against any Government initiative to grant CL on the pricing ground for expensive innovative drugs in India. At the same time, the patients will have much greater access to patented drugs than what it is today, due to Government procurement of these drugs at a negotiated price.

On the other hand, apprehensive voices as are now being expressed on this issue, just hoping for drastic measures of grant of frequent CL by the Government for improved patients’ access to innovative drugs, could well turn into a self-defeating prophecy – making patients the ultimate sufferers, yet again, as happens most of the time.

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.

Growing menace of counterfeit drugs in India: why is the domestic pharmaceutical industry still so apprehensive with the new Amendments of the ACT?

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The growing menace of Counterfeit drugs has remained a serious threat to the healthcare space of India.
Do we have any credible data to assess the magnitude of this menace in India?

No we do not have, as yet. At this stage, the magnitude of the problem is anybody’s guess. Earlier a study sponsored by the World Health Organization (WHO) and conducted by SEARPharm reported that only 0.3% drugs were spurious and 3% of drugs were counterfeits.

Government of India has initiated the largest study in the world to quantify the problem:

To scientifically assess the magnitude of the problem in terms of real size of counterfeit drugs market in India , the Drugs Controller General of India (DCGI) India’s, for the first time ever, has initiated one of the largest studies in the world, as reported by the Times of India May 14, 2008.

The study has already identified 61 popular drug brands from nine therapeutic categories for testing 24000 samples. These include drugs prescribed for tuberculosis, malaria, allergic disorders, diabetes cardiovascular conditions, vitamins etc. This study is expected to cost 50 million rupees or about U.S$1.0 million and is expected to be published, soon.

Making provisions for stricter penalties through amendment of the Drugs and Cosmetics Act, 1940:

To bring into effect stricter penalties for those involved in counterfeit drugs, the process of amendment of the Drugs and Cosmetics Act, 1940 was proposed by the Ministry of Health in October, 2007. These amendments are expected to make the drug-related offences, cognisable and non-bailable.

The latest amendment to the Drugs and Cosmetics Act, 1940 became a law in 2008. The punishment for selling or distributing spurious drugs, which are likely to cause death and grievous hurt to the patients, is now imprisonment for a term not less than 10 years and fine not less than Rs 10 lakh or three times the value of drugs confiscated, whichever is more.

The Minister of Health of India announced in November 2008, that with this amendment the Government of India will “go all out to do away with spurious drugs.”

India working closely with WHO Anti-counterfeiting Taskforce:

India being a part of ‘International Medical Products Anti-Counterfeiting Taskforce’ (IMPACT), established under WHO in 2006, decided to work together to combat the growing menace of counterfeit medicines.

The Drugs Controller General of India (DCGI) was reported to have several discussions with the convenor of the IMPACT to effectively address the issue of such serious threats to the patients at large. Many people believe that China and India are the main source of counterfeit drugs in the world.

Apprehensions of the Indian Pharmaceutical Industry with new Amendments in the Law:

Indian Pharmaceutical Industry although welcomed the stricter punitive provisions in the law, expressed its apprehensions due to lack of clear demarcation between the definitions of spurious drugs and those which can lose their original potency because of improper transportation and storage.

If the law-enforcing authorities pick up such medicines from retail outlets, those can easily get categorised as spurious medicines under Section 17A and 17B of the Drugs and Cosmetics Act, 1940. Consequently the concerned manufacturers could be put behind bars with, presumably, no fault at their end.

While stringent punishment is essential for those involved in such heinous crime, the Government should take enough measures to ensure that genuine drug manufacturers are not harassed by the law enforcing authorities, as the courts will have no judicial discretion to award less than minimum punishment, as prescribed under this Act.

Need for clear guidelines for implementation of the amended ACT:

To allay the major apprehension of the industry regarding possible misuse of some provisions of the Act, the Ministry of Health is expected to work out and quickly announce clear guidelines for implementation of the act by the law enforcement agencies in different parts of India.

Will this amendment help to win the fight against counterfeit drugs?

Only time will be able to give that answer. However, by amending the Act, the Government of India has demonstrated its resolve to address the threat of counterfeit drugs with iron hand. Through enunciation of above guidelines, all concerned are expected to be taken on board to effectively curb, if not totally eliminate this growing menace, for the sake of humanity.

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.