ROCHE AND TAMIFLU

Doing Business in the Shadow of Pandemic

• SG 3 :
• Imam Lukman Hakim
• Andina Liestyanti
• Dyah Meita RM
• Riska Ayu W
• Bayu Wibisono
 PANDEMIC AND

HOW IT IMPACT THE WORLD

What is
“Bird Flu”
?
How H5N1 can be transmitted
from person to person ?
The spread of avian •Source: WHO/GIP, data in HQ as of 20 January 2020
influenza in the •(https://www.who.int/influenza/human_animal_interface
/2020_01_20_tableH5N1.pdf?ua=1)
world hemisphere.
 The spread of
avian influenza
in the world
hemisphere.
Bird Flu H5N1
2003-2015
455 Deaths
861 Cases
( 52% Fatality Rate)
Comparison Spread Capability & Fatality Rate

https://www.nytimes.com/interactive/2020/world/asia/china-coronavirus-contain.html
Economic Impact of pandemic
Flu Pandemic deaths Global approximate value GDP is stands for "Gross
GDP
Domestic Product" and
Spanish Flu 1918-1920 20-40 - 12,6% $ US 4.4 Trillion represents the total monetary
million
value of all final goods and
Hong Kong flu 1968–1969 1 -1,4 - 0,8 % $ US 330 Billion services produced (and sold on
million
the market) within a country
Avian Flu 2003-2015 455 - 0,7 % $ US 405 Billion or area during a period of time
(typically 1 year)
Lowy Institute for International Policy, ―Global Macroeconomic Consequences of Pandemic Influenza,‖ February 2006

Exclude economic losses arising from : direct and indirect costs of illness, loss of future income due to early
death or chronic disability, loss of working time and income taken. creates ripple effects in the economy due to
fear

Human life Impact of pandemic

adaptation due to changing routines , labor dismissal , risk of increasing crime rates , resulting in some of the
same psychological effects and stress.
 Milestone on
Pandemic Treatment
1994 2003
WTO’s Agreement on Trade-Related Aspects of An Amendment to TRIPS allowed developing
Intellectual Property Rights (TRIPS) countries to exports drugs to other countries
with national health problem

The Doha Declaration created great conflict

between national governments and
Doha Declaration on TRIPS Agreement and Public pharmaceutical companies (Brazilian government
Health was adopted by WHO vs Abbott)

Nov. 2001 2005

Pharmaceutical Industry’s Position on Life-Saving Drugs

Pandemic Phases -
WHO

Source : WHO Global Influenza

Preparadness Plan, 2005, p.2
Flowchart for
Influenza Response
and Containment
Operations

Source : WHO, “Pandemic Influenza

Draft Protocol for Rapid Response and
Containment,” May 30, 2006, p. 18.
 • The Roche Group, headquartered in Basel, Switzerland, is active
in over 100 countries and in 2019 employed about 98,000
people worldwide. In 2019, Roche invested $13 Billion in R&D
and posted sales of $66.6 Billion. Genentech, in the United States,
is a wholly owned member of the Roche Group. Roche is the
majority shareholder in Chugai Pharmaceutical, Japan.
• Founded in 1896, Roche continues to search for better ways to
About prevent, diagnose and treat diseases and make a sustainable
contribution to society. The company also aims to improve
patient access to medical innovations by working with all
relevant stakeholders. More than thirty medicines developed by
Roche are included in the World Health Organization Model Lists
of Essential Medicines, among them life-saving antibiotics,
antimalarials and cancer medicines.
• Christoph Franz was confirmed as Chairman of the Board of
Directors with 99.52% of the votes on Roche Annual General
Meeting 2020.
 • Developed by Roche and approved in 1999,
Tamiflu has enjoyed widespread use in the US
and throughout the world, with global sales
surpassing $2.9B in 2009 due to H1N1 pandemic.
Business The figure above provides an overview of Tamiflu
sales on the US from 2013-2023, including a
Position of timeline of FDA approvals of generics beginning
in 2016.
Tamiflu (cont.) • In the three years preceding its loss of market
exclusivity in December 2015, Tamiflu sales
never dipped below $450M in the US, and with
the growing concerns surrounding the 2017–
2018 influenza season and persistent public
skepticism of vaccine effectiveness, GlobalData
 views the generic influenza antiviral market as
having healthy growth potential, as evidenced by
Tamiflu’s projected decline in sales from 2018–
2023.
Roche in Afix
• Intelectual Property Rightb. c. Government Pressure across the
worldd. Activists pressure (including alternative business model in
pharmacy industry). Sockpiling Tamiflu
 What Roche Faced
Activists pressure
1. Persuade roche to allow other
company to produce Tamiflu to
alleviate capacity
2. Pressure government to issue
compulsory license
Government Pressure across the world
1. Increase production capacity and
encourage licensing to 3rd party
2. Reduce the price
Intelectual Property Right
Under National Health Crisis, drugs for
life-threatened compulsory licensed from
manufacturer to government in Uruguay,
make Pharmaceutical firms worried
Royalties Vs Margin in the market
Royalties for compulsory licenses were
only in the 0 to 5% range
Stockpiling Tamiflu
Is it enough? How would Roche stock
would be?
Roche’s Strategy on Handling Government Pressure
No Country (es) Complaint Strategy
1 United States Some US legislators demanding Partially met by Roche’s sublicensing
compulsory license but some favored program
Roche
2 European Union EU make regulation so that compulsory
license is easier
3 Asia Demanding Roche to licensing generics Agreed to grant license
production
4 China dan India overriding patent protection and issue a Agreed to sublicense agreement with
compulsory license. generic manufacturer
Roche don’s have patent protection in India
and soon India produce generics Tamiflu
and sold to other Asian countries
5 Vietnam Demanding Roche to licensing generics Supplying API and local company will
production formulate into a tablet
6 Taiwan and Executing compulsory license and produce
Thailand generics Tamiflu because “communication
with Roche deadlocked”
 Pharmaceutical Industries Vs Activist
Revising current model of Health Service to
Developing Countries:
1. Strengthening Publicly Funded Research
Intelectual
2. Prize Models : by putting out requests for
Property
proposal for vaccine development for Malaria, TB
and AIDS
Patent 3. Exemptions for Developing Countries :
System compulsory license so developing countries able
to produce their own meds Decide to open
4. New Trade Framework
Temporary licence even
Monopoly (US currently still take side on patent protection. facing patent
However, act on compulsory license for Developing violation in
Countries agreement, especially for life-saving drugs,
still debatable) some
countries
Patent Drug Models Activist Proposal
 COVID-19

Current
Pandemic
 Brief Summary
The COVID-19 pandemic is an
ongoing pandemic of coronavirus
disease 2019 (COVID-19) caused
by severe acute respiratory
syndrome coronavirus 2 (SARS-
CoV-2)
The disease was first identified in
December 2019 in Wuhan ,
China, became a Public Health
Emergency of International Concern in
January 2020, and subsequently
recognised as a pandemic.
As of 29 September 2020, more than
33.4  million cases have been reported
worldwide, although the true number
of cases is likely to be much higher.
Based on Johns Hopkins University
statistics, the global death-to-case ratio
is 3.0 percent (1,002,676 deaths for
33,401,514 cases) as of 29 September
2020.
 Comparison of Covid-19 with other pandemic

Source: Petersen E, et al. Comparing SARS-CoV-2 with SARS-CoV and influenza

pandemics. The Lancet. Volume 20, Issue 9, E238-e244, September 01, 2020
Brief Summary
 TREATMENT & PREVENTION
Current treatment
Antiviral medications are under investigation for
COVID-19, though none have yet been shown to be
clearly effective on mortality in published
randomised controlled trials.
Antiviral medications are under investigation for
COVID-19, though none have yet been shown to be
clearly effective on mortality in published
randomised controlled trials.
Prevention
A COVID‑19 vaccine is a biotechnology product
intended to provide acquired
immunity against COVID‑19. As of September 2020,
there were 321 vaccine candidates in development,
a 2.5 fold increase since April. However, no
candidate has completed clinical trials to prove its
safety and efficacy . In mid-September, some 42
vaccine candidates were in clinical research :
namely 33 in Phase I–II trials and 9 in Phase II–III
trials 

Taking OTC cold medications, drinking fluids, and

resting may help alleviate symptoms.  Depending
on the severity, oxygen therapy , intravenous fluids ,
and breathing support may be required. 
 Ethics issues concerning covid-19 pandemic
In the midst of this global pandemic, we must leverage our
global governance bodies to allocate, distribute, and verify
the delivery of the Covid 19 vaccine. We need the
science — not politics — to inform the global strategy.

We have the organizations, institutions, and tools to

distribute a Covid-19 vaccine effectively and efficiently. All
countries have to remember that it is the virus, not each
other, that is their foe.

A nationalistic stance toward the pandemic will prolong

this global health and economic crisis. A vaccine must be
allocated on the basis of the best evidence of what will stop
transmission and protect the most vulnerable groups — no
matter in which nation they reside.

A vaccine can end the pandemic but only if all countries

ensure timely, equitable, global access to it. Selling vaccines
Harvard Business Review, May 2020 to the highest bidders is not the way to go.
BADAN POM’s STRATEGIC SUPPORT FOR PANDEMIC COVID-19

Laboratory for Biohazard PCR Testing Donation Control of Drug Public Service fully online

Regulatory Assistance for Drug and Vaccine Regulatory Assistance for Herbal Communication, Information and Education via Online and
Medicine Offline (webinar, infographics, guidance book)
28
“LATAH SITUATION” FOR PANDEMIC COVID-19