With ‘Cutting Corners’ Going North, Pharma Reputation Dives South

Just a few months ago, on October 24, 2017, ‘New Jersey Law Journal’ came out with an eye-catching headline – “Sanofi Set to Pay $ 61M Settlement in Antitrust Suit Over Vaccine Bundling.” The suit says: “Sanofi-Pasteur allegedly suppressed competition for its pediatric meningococcal vaccine, Menactra, by charging physicians and hospitals up to 35 percent more for its product, unless they agreed to buy Sanofi’s pediatric vaccines exclusively. Sanofi-Pasteur is the vaccines division of French drug manufacturer Sanofi.”

Nevertheless, a statement from the company said: “Despite Sanofi’s strong defenses, Sanofi recognizes that continued litigation is likely to be extraordinarily expensive and time-consuming and thus has agreed to enter into this Settlement Agreement to avoid the further expense, inconvenience, risk and distraction of burdensome and protracted litigation. Sanofi is finally putting to rest this case by obtaining complete dismissal of the action and a release by settlement class members of all released claims.”

When such incidences – of various scales and dimensions, continue being reported by both the global and local media, over a long period of time, one can fathom the potential of their cumulative impact on public and other stakeholders. Severely dented image and reputation of pharma, in general, before the eyes of so many, across the world, is a testimony to this phenomenon. Considering these as ‘cutting corners’ syndromes, I shall discuss in this article, how fast is pharma reputation diving South, with incidences of ‘cutting corners’ keep going North.

‘Cutting Corners’:

The Oxford dictionary defines ‘cutting corners’ as: ‘Doing something perfunctorily so as to save time or money’. Putting it in the context, I reckon, legally or ethically questionable actions with a deliberate intent of making quick profits, if not profiteering, can be termed as ‘cutting corners’ or business malpractices.

‘Cutting Corners’ going North:

This is no way a recent phenomenon. Gradually increasing number of new reports on pharma’s alleged malpractices are not uncommon, either. On the contrary, these keep coming rather too frequently – baffling many industry watchers and its well-wishers, for different reasons.

The details of 20 largest settlements in this area reached between the United States Department of Justice and various pharmaceutical companies from 1991 to 2012, as available from Wikipedia, provide a glimpse to its magnitude and dimension. The settlement amount reportedly includes both the civil (False Claims Act) settlement and criminal fine. Glaxo’s US$ 3 billion settlement is apparently one of the largest civil, False Claims Act settlement on the record, and Pfizer’s US$ 2.3 billion settlement includes a record-breaking US$ 1.3 billion criminal fine. A federal court also recognized all off-label promotion as a violation of the False Claims Act, leading to a US$ 430 million settlement during that period, as this report highlights.

In one of my articles, titled ‘Big Pharma Receives Another Body Blow: Would Indian Slumber End Now?’, published in this blog on May 19, 2014, I quoted a few more examples from 2013 and 2014, as well. A few of these are as follows:

  • In March 2014, the antitrust regulator of Italy reportedly fined two Swiss drug majors, Novartis and Roche 182.5 million euros (U$ 251 million) for allegedly blocking distribution of Roche’s Avastin cancer drug in favor of a more expensive drug Lucentis that the two companies market jointly for an eye disorder.
  • Just before this, in the same month of March 2014, it was reported that a German court had fined 28 million euro (US$ 39 million) to the French pharma major Sanofi and convicted two of its former employees on bribery charges.
  • In May 2013, Sanofi was reportedly fined US$ 52.8 Million by the French competition regulator for trying to limit sales of generic versions of the company’s Plavix. 

Pharma reputation dives South:

That pharma reputation is diving south, is well captured in the ‘Business and Industry Sector Ratings’ by Gallup, dated August 2-7, 2017. According to this public rating, the top 5 and bottom 5 industries came up as follows:

Top 5:

Industry Total Positive % Neutral % Total Negative % *Net positive or negative %
Computer

75

15

8

+67

Restaurant

72

21

7

+65

Farming and agriculture

70

17

12

+58

Grocery

60

23

17

+43

Internet

59

21

18

+41

The bottom 5, including the federal government:

Industry Total Positive % Neutral % Total Negative % *Net positive or negative %
Airline

41

20

35

+6

Oil and gas

38

21

40

-2

Healthcare

38

18

45

-7

Pharmaceutical

33

16

50

-17

Federal Govt.

29

19

52

-23

*Net Positive is % Positive minus % negative (in percentage points)

Image rejuvenation campaign not yielding results:

Arguably, the richest and the most powerful pharma industry lobby group in the largest pharmaceutical market of the world, is incurring a mind-boggling sum of expenditure to mend the severely dented collective reputation and image of its members.

Vindicating this point, a January 18, 2017 media report articulated that a major pharma industry lobby group – PhRMA, is gearing up for a new image building campaign by spending in the “tens of millions” each year to drum up support for the reputationally challenged pharma industry. Such initiatives by PhRMA, as I understand, are not totally new, but rather ongoing. Be that as it may, as the Gallup survey confirms, pharma reputation keeps diving South, unabated.

Mending pharma’s reputation surfaces as one of the top concerns of the pharma industry. It, therefore, demands commensurate priority in working out a meaningful strategic plan, and its effective implementation on the ground, collectively. More so, when the POTUS – Donald Trump, has also emerged as a vocal pharma critic. He has already proclaimed that drug companies “are getting away with murder,” – as the above media report highlights.

Where is this campaign going off the mark?

On this subject, an article of September 5, 2017, published by Ars Technica – a technology news publication aptly epitomized, what is happening today with these campaigns, against what should have happened, instead. The column carries a headline ‘Big Pharma hopes research spending – not reasonable pricing – will improve image’.

The columnist wrote: “To scrub down their filthy reputations, drug makers could try lowering prices, a public mea culpa, or pledging to make pricing and marketing more responsible and transparent. But they seem to have taken a different strategy.” On this score, a relevant example, out of several others, was of Biogen introducing a drug in 2016, for a rare spine disorder and priced it at an eye-popping US$ 750,000 for the first years’ worth of treatment.

In pharma image revamp campaign, the focus on R&D spending or drug innovation, including blatant self-serving demands, such as strictest product patent and data exclusivity provisions, is rather overwhelming. It is understandable that all this fits in well with various pharma lobby group’s mission and mandate, but is unlikely to deliver what consumers would consider good behavior on the part of drug companies.

Is Indian pharma out of this loop?

The answer to this question is an emphatic – ‘No’. Alleged ‘dubious product quality’ related ongoing saga, is known today by all concerned. This had often culminated into US-FDA import bans of many drugs, manufactured by several Indian drug manufacturers – starting from the very top. Nonetheless, that’s not ‘the all’ or ‘end all’ in the ballgame of ‘cutting corners’ in India, as I explained above.

On September 26, 2017, a media report flashed: ‘The Income Tax (IT) investigation wing claims to have unearthed a nexus between a leading pharmaceutical company and doctors, and the evidence showing payments running into Crores to the latter for prescribing the company’s medicines.’

Close on the heels of ‘compromised drug quality standard’, such malpractices come as a double whammy for patients. But, the saga continues. In my article, titled ‘Healthcare in India And Hierarchy of Needs’, published in this blog on November 06, 2017, I mentioned about the October 31, 2017 public notice of the State Attorney General (AG) of Connecticut. The notice cited several instances of alleged drug price fixing in the United States. Interestingly, this lawsuit includes name of several large Indian companies, such as Dr. Reddy’s Laboratories, Emcure, Glenmark, Sun Pharma, and Zydus Pharma. The expanded complaint also names two individual defendants, one among them is the promoter, the chief executive officer and managing director of a large Indian pharma manufacturer.

Further, as I wrote before, the Maharashtra government’s recent announcement on enactment of a new law called the “Cut practices in Medical Services Act, 2017”, casts a darker shadow, not just on the doctors’ reputation, but also over the health care industry, in general, including pharma.

Today’s patients are more informed:

In today’s world, wider access to the Internet for a large number of global population has a profound implication in every sphere of life. News, discussions, opinions, comments and a plethora of other information on various industries, including pharma, are available from different credible websites, just as anything else.

Additionally, the social media, collectively, have made exchanges and interpretations of such information within various groups and communities, as fast as these could be. Just as many other different things, wrongdoings or malpractices, if any, of various industries, also get quickly captured and shared by the Netizen with ease and élan. These include incidences of ‘cutting corners’ by constituents of the pharma industry too.

Conclusion:

The Public Relationship campaigns of pharma lobby groups, with a hope to bridging the industry’s ‘trust deficit’, have been reported from the United States and other countries. However, any such campaign for the pharma industry in India hasn’t arrested my attention, as yet.

It’s beyond any reasonable doubt or debate that the pharma industry, in general, has saved and is still instrumental in saving more lives, in every nook and corner of the world. Ironically, the same industry, for its own deeds prompted mostly by the self-serving needs, has been suffering a massive collateral damage.

The industry’s long unblemished image and reputation have been severely tarnished,   requiring rejuvenation with an inclusive approach. This may call for a mindset, at least, nearer to the same of George W. Merck – the legendary President and Chairman Merck & Co., Inc. He articulated a vision – “Medicine Is For The Patient, Not For The Profits”, and practiced it religiously. In today’s context, this may sound rather utopian in letters, but surely not in its spirit… be that as it may….

Pharma lobby groups hope to reverse the current trend by focusing only on R&D spending, drug innovation and strictest patent protection and data exclusivity ecosystem is apparently a non-starter. That ongoing multi-million-dollar pharma image revamp campaigns haven’t yet captured any tangible positive outcomes – not even in the United States, is possibly a testimony to this fact.

The status quo is expected to continue. More so, when ‘reasonable pricing’ of drugs is one of the top most demands of patients, patient groups and even many governments – and that’s exactly where the buck stops in pharma business.

In my view, pharma reputation restoration process isn’t merely a one-sided communication issue, as it appears today. A strategic blue print of this critical industry need, deserves to be drawn on a much broader canvass with a patient-serving mindset, instead of just a self-serving one. Otherwise, with incidences of ‘cutting corners’ going North, pharma reputation will keep diving South… till it finds its very bottom.

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 Vaccine Market of India: A rejuvenation is in progress

Even in couple of decades back, ‘Vaccines Market’ in India did not use to be considered as a focus area by many pharmaceutical companies. Commoditization of this market with low profit margin and unpredictable interest of the government/the doctors towards immunization were the main reasons. Large global players like Glaxo exited the vaccine market at that time by withdrawing products like, Tetanus Toxoid, Triple Antigen and other vaccines from the market.

Currently, the above scenario is fast changing. The vaccine market is getting rejuvenated not only with the National Immunization Program (NIP) of the country, but also with the emergence of newer domestic vaccines players and introduction of novel vaccines by the global players, which we shall discuss below.

In addition, the ‘Indian Academy of Pediatrics (IAP) Committee on Immunization’ now recommends the ‘best individual practices schedule’ for the children in consultation with their respective parents. Such schedule may not conform to NIP and include newer vaccines, broadening the scope of use of vaccines in general.

Global Market:

According to GBI Research Report, overall global vaccines market was valued at US$ 28 billion in 2010 and is expected to reach US$ 56.7 billion by 2017 with a CAGR of 11.5%. The key growth driver of this segment will be introduction of newer vaccines, which are currently either in the regulatory filing stage or in the late stages of clinical development.

The important international players in the vaccines market are GlaxoSmithKline, Sanofi, Pfizer, Novartis AG, Merck and SP-MSD, representing around 88% of the total vaccine segment globally.

Indian Market:

Year

Value

   Rs. Cr.

Growth  %

2007

389

-

2008

383

-2

2009

476

24

2010

726

53

Source: IMS – Health MAT June 2010

India is one of largest markets for all types of vaccines in the world. The growth is being driven by the new generation and combination vaccines, like DPT with Hepatitis B, Hepatitis A and Injectable polio vaccine. The demand for veterinary vaccines is also showing ascending trend. Pediatric vaccines contribute to around 60% of the total vaccines market in India.

McKinsey in its report titled, “India Pharma 2020: Propelling access and acceptance, realizing true potential“ stated that at 2% penetration, the vaccines market of India is significantly under-penetrated with an estimated turnover of around US$ 250 million, where the private segment accounts for two-thirds of the total. McKinsey expects the market to grow to US$ 1.7 billion by 2020.

In India companies like, Serum Institute, Shantha Biotecnics, Bharat Biotech and Panacea Biotech are poised to take greater strides in this direction. Bharat Biotech is incidentally the largest Hepatitis B vaccine producer in the world. Likewise, Serum Institute is reportedly one of the largest suppliers of vaccines to over a 130 countries of the world and claim that ’1 out of every 2 children immunized worldwide gets at least one vaccine produced by Serum Institute.’

Indian Vaccine Market:  Domestic vs MNCs:

In the domestic vaccine market the market share of the Indian players is gradually improving as compared to their multinational counterparts.

Types

June 2009 MAT

% Value Growth

June 2010 MAT

% Value Growth

Indian Companies

55%

27

59%

64

MNCs

45%

21

41%

38

Source IMS-Health – June 2010 MAT

Indian Vaccine Market: Top 10 Companies:

Rank

Company

Value     (Rs. Cr)

%Market Share

%Value Growth

Vaccine Market

726

100

53

1

GSK

131

18

23

2

Sanofi Aventis

129

18

>>

3

Pfizer

71

10

75

4

Novartis

68

9

-12

5

Serum Institute

68

9

40

6

Panacea Biotech

59

8

57

7

VHB Lifesciences

33

5

>>

8

Zydus Cadila

32

4

56

9

MSD

31

4

>>

10

Shantha Biotech

24

3

15

Source IMS-Health – June 2010 MAT

Indian Vaccine Market: Top Therapies:

Therapies

Value

     (Rs.Cr.)

%Market Share

% Value Growth

Incr. Value          (Rs. Cr)

June’09 MAT

June’10 MAT

June’09 MAT

June’10 MAT

Vaccine Market

726.1

100

24

53

93

250

Toddler Vaccine

211

29

55

60

47

79

Adult Vaccine

205

28

-4

22

-7

37

Paediatric Combination Vaccines

146

20

67

>>

28

77

Paediatric Single Vaccines

131

18

25

32

20

32

All Other Vaccines

33

5

431

6

27

Source IMS-Health – June 2010 MAT

Indian Vaccine Market: Top 10 Brands:

Rank

Brands

Company

Value

       (Rs.Cr.)

Value Growth %

Incr. value   

(Rs. Cr.)

June’09 Mat

June’10 MAT

June’09 Mat

June’10 MAT

Vaccine Market

726

24

53

93.1

250

1 Prevenar Pfizer

71

150

75

24

30

2 Rabipur Novartis

68

4

-12

3

-9

3 Pentaxim Sanofi Aventis

46

>>

>>

7

39

4 Havrix GSK

37

9

47

2

12

5 Varivax VHB

33

59

>>

5

18

6 Vaxirab Zydus Cadila

32

-11

56

-3

11

7 Varil Rix GSK

25

-3

-9

-1

-2

8) Gardasil MSD

22

—-

>>

5

16

9 Verorab Sanofi Aventis

21

—-

—-

0

21

10 Rotarix GSK

21

—-

>>

10

11

Source: IMS-Health – June 2010 MAT

Indian Vaccine Market: Top 10 New Introductions:

NIs

Company

Launch Date

Value

(Rs. Cr)

Incr. Value

(Rs. Cr)

Vaccine Market

104

79

Gardasil MSD 10/2008

22

16

Rotarix GSK 07/2008

21

11

Pentavac Serum Institute 10/2008

16

12

Cervarix GSK 02/2009

11

10

Polprotec Panacea Biotech 07/2008

9

6

Xprab Ranbaxy 10/2009

7

7

Quadrovax Serum Institute 11/2008

4

3

Comvac- 5 Bharat Biotech 02/2009

3

3

Pentavac – SD Serum Institute 11/2009

2

2

Shan HIB- DPT Shantha Biotech 09/2008

2

1

Source:IMS-Health – June 2010 MAT

Action areas to boost growth:

McKinsey in its above report ‘India Pharma 2020’ indicated that the action in the following 4 areas by the vaccine players will drive the vaccine market growth in India:

  • Companies need to go for local production of vaccines or leverage supply partnerships. GlaxoSmithKline’s local partnership for the HiB vaccine with Bio-manguinhos in Brazil has been cited as an example.
  • Companies will need to conduct studies on the economic impact of vaccination and establish vaccine safety and performance standards.
  • Extension of vaccine coverage beyond pediatricians and inclusion of general practitioners, consulting physicians and gynaecologists will be essential.
  • Companies will need to enhance supply chain reliability and reduce costs.

Conclusions:

On January 7, 2012, while requesting the ‘Overseas Indian Medical Professionals’ to partner with the institutions in India, the Health Minister, in his address, announced that the Ministry of Health has already introduced the second dose of measles vaccine and Hepatitis-B vaccination across the country. Moreover, from December, 2011 a ‘Pentavalent Vaccine’ has been introduced, initially in 2 States, covering 1.5 million children of India.

All these augur quite well for the country. However, keeping in view of the humongous disease burden of India, immunization program with various types of vaccines should receive active encouragement from the government as disease prevention initiatives, at least, keeping the future generation in mind.

If such policy measures are initiated in the country, without delay, the domestic vaccine market , in turn, will receive further growth momentum, together with newer players and modern vaccines coming in, to help addressing effectively a significant area of the healthcare concerns of the country.

By: Tapan J Ray

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