IFPMA code changes between

2012 and 2019

Industry funded CMEs
Evergreening of patents
Prescription data mining

Presented by -
Ritika Agarwal(A003)
Hashman Warring (A049)
Manvir Singh (A057)
Zeeshan Patel (A029)
Palak Pandya (A056)
Code of
Practice
Key changes

2019
 The Evolution of the Code

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Practice aims to ensure
that pharmaceutical industry practices are governed by ethical standards, as well as remaining in line with societal
expectations.

The code was first drawn up in 1981 and has been revised five times since, most recently in 2019, with each revision
reflecting changes to the external environment, rules and regulations change, and societal expectations.

Eli Lilly chief ethics and compliance officer Melissa Barnes led the development of the 2019 edition, which features
amendments with two main focuses. The first is the introduction of a ban on gifts and promotional aids for
prescription-based medicines, and the second is the inclusion of an IFPMA ethos.
 The IFPMA
Ethos puts
trust
at its center
Moved from a Code based on rules to a culture
grounded in integrity, values and principles – and,
most importantly, patient trust.
The Ethos is the foundation that shapes how the
R&D based biopharmaceutical industry sustains
trust based on the core values of care, fairness,
respect and honesty in line with ever-changing
society’s expectations.
The Ethos serves to instil a culture of ethics and
integrity needed to guide
our business behaviours and interactions between
IFPMA members and the healthcare community.
How
did we
get here?
Code Revision Roadmap
Assessment of
eBIC meeting
specific
• Discussion, review and Finalisation and Approval by
implications ,
debate in Working Groups approval of IFPMA General
creation and
• Surveys on specific topics revised code Assembly
discussion of
• Presentation of first Company internal
through vote
working draft
outcomes during meeting socialization
end of march in Geneva

eBIC meeting Based on feedback Presentation to

Washington Decision on working draft and approval by
to broaden revision creation of 1st draft. IFPMA Council
and deep dive into Review by eBIC end
several topics Preparation of final Working of Jan. 2nd draft review
Group results for discussion by eBIC and
during eBIC meeting mid further
October in Beijing, creation of socialization
Code Revision Steering
Committee
 What
is new?
1. Ethos
2. Ban on gifts/ Promotional
Aids
3. Compliant procedure
4. Other minor changes
Our Ethos Building a culture of trust
Our Ethos Building a culture of trust
Our Ethos Building a culture of trust
Our Ethos Building a culture of trust
Introduction of the IFMPA ethos
What impact will that have?
• The Ethos underpins the rules of the IFPMA Code of Practice and provides a framework to behave with integrity no
matter how testing the circumstances.

• The Code is a unified set of values that we can apply in the grey spaces when people are making decisions. If you
take a copy of the Code, the ethos is not at the beginning or the end; it’s physically at the heart of it. It’s a
recognition of how we need to conduct our business from beginning to end—from research and discovery to
making and distribution—to ensure that our patients are safe post-prescription.

• The ethos provides a backdrop to support those decisions companies and associations make daily. It’s intended to
be our lighthouse or our guide to ensure that we as a collective industry—our association members and our
industry member—can use that to help guide our decisions along the way.

• The committee was called the Code Compliance Network which is now renamed as The Ethics and Business
Integrity Committee because if you shoot for compliance, you might just get compliance and you don’t necessarily
get ethics and integrity. However, if you shoot for integrity, you very naturally get compliance.
 What
is new?
1. Ethos
2. Ban on gifts/ Promotional
Aids
3. Compliant procedure
4. Other minor changes
 Gifts and other Items to HCPs (section 7.5)
Added general clarification to chapter 7.5:

“Items in this section, where permissible, must never

constitute an inducement to prescribe, recommend, purchase,
supply, sell or administer a pharmaceutical product.

Ban on Gifts:
Gifts for personal benefit already banned since 2012 but as of
Jan 2019, no more exception., i.e. cultural courtesy gifts like
condolence payments also prohibited. Providing or offering
cash, cash equivalents or personal services is also prohibited.

Added clarification : “gifts, whether provided directly or

through clinics and institutions”.
Ban on Promotional Aids (for Rx-based
medicines)
Non-monetary reminder items:
Examples: post-its, mouse pads, calendars,
plasters, bags etc

2012 code allowed if relevant to the practice

of HCP, but now full ban in relation to the
promotion of prescription-only medicines.
However excluded for:
• The promotion of OTC medicines if relevant to the
practice of the HCP.
• Pens and notepads at company organised events
for the purpose of taking notes during the meeting.
• Not product, only company branded, of minimal
value and in the necessary quantity for the purpose
of the event.
 Items of Medical Utility
Examples: inhalation devices (without API) or devices
intended to assist patients to learn how to self-inject,
software or mobile apps (BMI calculator)
Already restricted in 2012, but now further clarified.
Items of medical utility can include the company
name, but must not be product branded, unless the
product’s name is essential for the correct use of the
item by the patient.
Such items may only be offered if:
• They are of modest value
• They are not expected to be supplied by the HCPs
themselves or their employers i.e. for routine
business practice (e.g. Stethoscope, surgical gloves,
needles)
• They are beneficial to enhancing the provision of
medical services and patient care
• They are not offered on more than an occasional
basis, even if each item is appropriate.
 Informational or Educational items
that enhance Patient Care

New section under chapter 7.5 “Gifts and other Examples:

items to HCPs”.
Such items may be provided to HCPs for their
education or for the education of patients on
disease and its treatments, provided that the items
are primarily for educational purposes and do not
have independent value.
Scientific books, journal subscriptions,
memory sticks with educational data.
Memory sticks pre-loaded with educational or
informational data may be appropriate if
storage capacity is commensurate with
materials provided
Tablet computers have independent value to
an HCP and must not be provided.
Informational or Educational items
that enhance Patient Care

Can include the company name, but must not be

product branded, unless the product’s name is
essential for the correct use of the item by the patient.

The value of books and subscriptions must be

reasonable. Other informational or educational items
must be of modest value.

Consider the cost as well as the overall benefit to an

individual HCP in a given year.
 What
is new?
1. Ethos
2. Ban on gifts/ Promotional
Aids
3. Compliant procedure
4. Other minor changes
IFPMA Complaint Procedure
Scope has not changed, but alignment with the requirements in the
Preamble has been ensured

Procedure has ben updated:

• Second review by Appeal group in validation of a complaint
• Time limits: calendar days replaced by working days
• Adjudication and Appeal groups elected for two instead of one year
• Section added on anonymous complaints (still accepted but provision of
contact details is encouraged)
• Oral hearing in the context of the Appeal Procedure now possible
IFPMA
Complaint
procedure
 What
is new?
1. Ethos
2. Ban on gifts/ Promotional
Aids
3. Compliant procedure
4. Other minor changes
Other minor changes
• IFPMA address
• Name of Ethics Committee
• Clarification on events involving foreign travel (7.1.2)
• Accompanying guests (7.3)
• Reimbursement of reasonable expenses for
services compensation (7.4)
• Guidance in values (7.5.4)
• Q&A adapted to Code revisions
 Reimbursement of
Clarification on events
reasonable expenses for Guidance on Values
involving foreign travel
services compensation
No company may organize or sponsor The compensation for the services Member associations shall provide
an Event for HCPs (including must be reasonable and reflect the guidance using local currency, on
sponsoring individuals to attend such fair market value. The compensation acceptable monetary amounts for the
an Event as described in Article 7.2) arrangement may include following:
that takes place outside of the ---- reimbursement of reasonable “minimal value” for promotional aid
HCP’s home country to HCP’s country expenses including travel, meals and items;
of practice----unless it is appropriate accommodation. “modest value” for items of medical
and justified utility and informational &
to do so from the logistical or security educational items;
point of view. International scientific “reasonable value” for scientific
congresses and symposia that derive books & journal subscriptions
participants from many countries are
therefore justified and permitted. Accompanying guests
Companies must not pay any costs
associated with individuals
accompanying invited HCPs,
except in cases of medical
necessity.
Industry
funded CME
And unethical
practices
related to it
 • At CME events, practitioners can keep up
to date with the latest trends and
medical technology.
• Attending events also provides a great
opportunity to refine skills
Ideal purpose of • Network with other providers
CME’S • Find solutions to problems experienced
in practice.
• Many conferences have workshops and
practical sessions to try out new skills
and practice with new techniques and
technologies.
 Ideal purpose of CME’S
• Another benefit to physicians and other healthcare providers is
professional growth. CME events are an ideal place to network
with experts in the field and meet face to face with those
conducting the latest research.
• Speaking at a conference will increase one’s credibility and
distinction in their specialty.
• This is also a great opportunity to earn memberships to
prestigious professional organizations.
 • In an ever-changing world of medicine,
continuing medical education (CME) programs
are considered an inescapable requirement.
• More than half of all professional conferences
and CMEs are organized with the help of
sponsorship from pharmaceutical companies
Changing CME Trends and device manufacturers
• With increasing sponsorship, the venue and
character of these conferences has
significantly transformed
• CMEs that were earlier organized austerely by
medical colleges on their campus are now
organized by private practitioners in seven-star
hotels and even on luxury liners
 Changing CME Trends
• Sponsors therefore have a major say in selection of topics to be
discussed and speakers to be invited.
• Unbiased knowledge cannot be imparted in this scenario
 • If one had to approach a doctor with a sales
pitch, it would be wise to approach him in a
conference rather than his chamber. It is in
the conferences that doctors let their hair
down and behave like students
What is • The basic mantra is that ‘Food, flattery and
Pharmaceutical friendship can get anything done.
• Promotional information is fed in the guise of
Industry's scientifically published data.
• Published and presented data is easily
Strategy? controlled by manipulating what is
published, and what is presented in
conferences.
 Unethical practices
• Every doctor is familiar with pharmaceutical representatives presenting him/her
small gifts when you visit their stall in a conference. What doctors fail to realize is
that these minor gifts will alter their prescribing habits in favor of drug names
printed on the gift.
• Industry often pressurizes the publishers of professional journals to accelerate or
retard publication of scientific papers to suit their commercial interests.
• The makers of antidepressants like ‘Prozac’ and ‘Paxil’ never published the results of
about a third of the drug trials conducted to win government approval, misleading
doctors and consumers about the drug’s true effectiveness.
• An analysis of all trials funded by the pharmaceutical industry pitting five new
antipsychotic drugs against one another were analyzed and it was noted that 90%
showed that the best drug was the one made by the company funding the study
• Clinical practice guidelines issued by professional bodies can be doctored. It
has been noticed that 60 to 90% of practice guideline developers have a
financial relationship with a company that makes a product addressed by
those guidelines.
• A recent example is that of erythropoietin use. National Kidney Foundation
formulated guidelines for anemia management in Chronic Kidney Disease
patients in 2006.
• Most leading experts of the initiative were consultants to companies
manufacturing erythropoietin.
• Guidelines recommended erythropoietin use at levels higher than warranted
by scientific evidence. It was found to significantly increase the risk of death,
myocardial infarction, congestive heart failure, and stroke
• Pharmaceutical companies pay “Ghost-writers” to draft papers with favorable
opinion about their drugs and get them published under the name of known
academic figures in reputed journals.
• It has been shown that nearly half of the best designed, peer-reviewed
scientific papers published in the world's top medical journals misrepresent
the actual findings of the research.
• Use “Key opinion leaders”: Pharmaceutical companies identify academically
respected doctors and pay them a handsome amount for delivering one
“scientific” speech with a hidden message
• Drug companies extensively support travel of doctors to conferences. Such
travel support significantly changes the prescribing behavior of
practitioners. A physician who accepts money to travel to a symposium is
up to ten times more likely to prescribe that company's drugs than a
physician who does not
• These days drug companies don't just promote pills, they also promote the
diseases to go with them.
• This is done by “Creation” of new medical disorders or by giving an old
condition a ‘makeover’.
• Social Phobia was marketed as Social Anxiety Disorder in the US in early
2000s, to promote excessive drug prescribing. This habit has also been
named “Disease-mongering”
• Drug companies organize Entertainment programs and local sightseeing
tours for the visiting delegates.
• Conference brochures also mainly highlight tourist information. Most
doctors attending the conferences show no interest in the academic
program.
• Many practitioners in India treat conferences as paid holiday, which they
visit with their entire family.
• Students and residents are possibly the most vulnerable group
• Organizers of APICON (Physicians’ largest National conference) had to issue
a request to pharmaceutical companies to refrain from organizing the
tours that interfere with doctors’ participation in such events,
 • Having understood that CMEs heavily influence
prescribing habits, many academic medical
centers have now started adopting new policies
to create firewalls between faculty and industry
influences
• Strict guidelines are being framed for
Preventive pharmaceutical company representative
interactions with residents
measures • Macy Foundation Report of 2007 suggested
that CME organizers “should not accept any
commercial support from pharmaceutical
companies” and “Faculty of academic health
centers should not serve as paid spokespersons
for pharmaceuticals
• The American Association of Medical Colleges have also decided
to ban all gifts, free meals, travel to meetings, and payment for
CME by pharmaceutical industry.
• They also recommend that in place of free samples to physicians,
pharmaceutical companies may provide vouchers for low-
income patients to get free medicine
• The institutions that have already implemented these measures
include Yale University, University of Michigan, University of
Pennsylvania, Stanford University, University of California-Davis,
Memorial Sloan-Kettering Cancer Center, Massachusetts General
Hospital and several others
• Medical Council of India has come out with a new code of ethics
• Elaborate inauguration programs to felicitate the VIPs can be done away with.
• An inaugural address by the chief guest or key note address by an eminent
professional is all that is required for inauguration.
• Practice of presenting bouquets to VIPs, singing devotional songs and
showering words of praise on each other wastes precious time of hundreds of
delegates who come to learn medicine.
• Doing away with conference bags, gifts, high tea, banquet and entertainment
programs will allow them to organize conferences within resources already
available.
• In place of spending most of their time and energy on ‘hospitality,’ the
organizers will do well to display their skill in making the training program
innovative, interactive and engaging.
EVERGREENING OF PATENTS
 Introduction

• Patent is an exclusive right given to the right holder to reap

benefits out of his invention. Internationally, it is the TRIPS
Agreement that regulates the law relating to Copyrights, Patents,
Trademarks and other forms of IPR.

• However, sometimes, this patent protection is sought to be

extended indefinitely by the patentee through the practice of
Evergreening.

• As research and development of novel drugs within

pharmaceutical multinationals has slowed down, they have
focused their energies on patenting minor tweaks to existing drugs
in order to extend monopolies, whenever possible.
• https://www.youtube.com/watch?v=bdzUMaxZt3g
 What is patent evergreening ?
“Evergreening" refers to the strategies whereby pharmaceutical companies use patent laws and minor
drug modifications to extend their monopoly privileges on the drug. Typically, these strategies are
developed before expiry of the patent of an original drug, usually a high-revenue drug. If obtained, it
results in an extension of the patent protection period or a new patent for a minimally modified version
of the drug and enables the innovators to retain monopoly over its product even after expiry of patent
term. The innovators usually bring in small changes and then claim patent rights for 20 years.

Evergreening strategies commonly adopted by the pharmaceutical industry are:

 Redundant extensions and creation of ‘next generation drugs’ which result in superfluous variation
to a product and then patenting it as a new application
 Prescription to over-the-counter (OTC) switch
 Exclusive partnerships with generic drug players in the market prior to drug patent expiry which thus
significantly enhancing the brand value and interim earning royalties on the product.
 Establishment of subsidiary units by respective innovator companies in generic domain before the
advent of rival generic players.
Consequence of patent evergreening

• A consequence of evergreening is the delayed entry

of generic drugs into the market with extension of
the original drug patent or competition between the
patent-protected minimally modified version of the
drug and generic drugs.

• This situation might increase drug reimbursement

costs by keeping the cheaper generic versions
completely or partly out of the market.

• Once generic drugs are under production, the price

of the drug can drop by as much as 90%. Additional
costs incurred through delay in generic entry can be
very significant for the public health budgets and
ultimately the consumer.
 Ethical Issue

The net cost for society of evergreening patents is

substantial. Evergreening patents interfere and
hinder fair competition in the pharmaceutical
market, with the result that pharmaceutical
companies can charge high monopoly prices for
far longer period than is justified.
 Indian patent act and
evergreening of patent
• India stopped granting drug patents in the 1970s, and only
resumed granting drug patents in 2005 as part of a World
Trade Organisation agreement.

• The government introduced amendments in Indian Patent

Act (Amendment) Bill 2005.

• Indian patent law has provision which prohibits a new form

of a known substance from receiving a patent unless it
significantly improves the medicine’s "efficacy". The provision
was aimed at preventing "evergreening".

• Section 3(d) of the Indian Patent Act, 1970, states that the
mere discovery of a new form of a known substance, which
does not result in the enhancement of the known efficacy of
that substance or the mere discovery of any new property or
new use for a known substance or of the mere use of a
known process, unless such known process results in a new
product or employs at least one new reactant, is not an
invention within the meaning of the Patents Act.
 In which case will patent
extension be granted?

 Case 1-Sildenafil Citrate was originally discovered as a

cardiovascular agent and patented by Pfizer. Later, its
second medical use in treating impotence was also
found.

 Case 2-Griseofulvin is an effective agent for fungal

infections of skin to be locally. Later, it was found that if
the dimensions of the particles of the drug were
reduced, it could be used orally as reduced particle size
led to increased oral efficacy.
 Novartis-Glivec case
• Novartis filed an application before the Chennai patent office related to a drug name GLIVEC which
was slightly a different version of its 1993 patent for Anti Leukemia drug.

• The Assistant Controller of Patent and design, Chennai Patent Office rejected the application under
section 3(d).

• Novartis responded with a writ to the High Court appealing against the ruling. It argued that Section
3(d) of the Indian Patent Act was “unconstitutional as it is vague, arbitrary and violative of Article 14
of the constitution (right to equality) and alleged that it contravened India’s obligations under the
TRIPS Agreement.

• The Court held that, In the light of above observation, it was held that section 3 (d) of the Patent
(amendment) Act 2005 does not violate Article 14 of the Indian Constitution.

• After exhausting all remedies, the pharmaceutical giant moved the Supreme Court. Novartis lost a
six-year legal battle after the court ruled that small changes and improvements to the drug Glivec did
not amount to innovation deserving of apatent.
 Not granting patents on the basis of trivial and
insignificant changes in the original pharmaceutical
patented product.

Ensuring that generic manufactures can manufacture

HOW TO AVERT the patented pharmaceutical product soon after the
term of patent expires, by making use of Bolar
EVERGREENING? provision.

Bolar” provision under Section 107 A (a) of the Indian

Patents Act that permitted a drug manufacturer to
experiment with any patented drug for generating
data that could then be submitted to a drug
controlauthority.
 Conclusion
• Section 3(d) forces firms to focus efforts on
innovation and hardcore research instead of
incremental improvement and have patents for
every minor innovation.

• Section 3(d) can also be seen as a great boon with

generic pharmaceutical firms, AIDS campaign and
Non-Governmental Organization (NGO) backing
India.

• Other companies can continue to produce cheap

versions of life-saving drugs faster.
 What
is Data
Mining?
1. Concept
2. Business Intelligence
3. Social media data mining
for prescription medication
abuse.
CONCEPT
Data mining is identified as the act of using automated tools to
discover patterns within large datasets.

Mining refers to looking for means than actual searching of data

Big Data emphasizes not only of volume but also its complexity

Basic framework for pattern discovery is as follows:

• Essential step: Framing queries
• Understanding variations: Why and how those patterns occur?
• Decision Making: What they mean in relation to a particular use case?
DIGGING DEEPER INTO THE CONCEPT
Data mining in healthcare industry can be understood through
addressing business cases .

Clinical Data Mining business case examples:

• Case 1: Identifying unnecessary utilization of high cost service such as imaging

tests or emergency department use.
• Case 2: Tracking the prescription rate of a certain opioids by a provider?
• Case 3: Measuring provider performance on a given process measure?
E.g: delivering colonoscopies or corona virus vaccinations.
THE AGE OF
BIG DATA
HAS
ARRIVED BIG DATA
Million Thousand
2.8 Million
Social 2.5 Website
search queries
27.2 Review
posts
Media
posts

100 201
Hours Million
of Online emails
videos sent

EVERY
MINUTE

Reference: Microsoft Analytics

Social media data mining for prescription
medication abuse

Prescription medication (PM) misuse and

abuse is a major health problem globally

Need for exploring social media as a resource

for monitoring nonmedical PM use

Lack of surveillance mechanisms that would

enable investigations on the factors contributing
to PM abuse
Social media data mining for prescription medication
abuse
Overview of the article
• Objective: Review social media based PM abuse and proposing a data centric
processing framework.

• Materials and methods: Studies from social media, PMs and misuse or abuse from
Medline, Scopus, Web of Science and Google Scholar.

• Result:
• Recent searches – Twitter, Reddit and Instagram are popular resources
• Growth trend is expected towards data-centric methods which will involve natural
language processing and machine learning.
 Need of the Hour
Do we deserve this?
Aren’t we worthy of a better health?

Why Re-create? When we can co-

create and be the best.

We are the youth, let’s live better

Change, it starts with us