Contemporary Legal and Ethical Issues in

Marketing Pharmecuticals in Pakistan.

 Mahreen Nazar
Assistant Professor, Department of Accounting and Law
Institute of Business Administration (IBA), Karachi
Pakistan
e-mail: mnazar@iba.edu.pk

Azad Ahmed
MBA
Institute of Business Administration (IBA), Karachi
Pakistan
e-mail: azad.ahmed@iba.edu.pk.khi
 Presentations Agenda
Literature review
Research Aim
Research Objectives
Methodology & Methods
Main Results & Findings
Papers Conclusion
New understandings
Literature Review
 Pakistan has a very vibrant and forward looking Pharma
industry. At the time of independence in 1947, there was
hardly any pharma industry in the country. Today Pakistan
has about 400 pharmaceutical manufacturing units
including those operated by 25 multinationals present in
the country. The Pakistan Pharmaceutical Industry meets
around 70% of the country's demand of Finished Medicine.
The domestic pharma market, in term of share market is
almost evenly divided between the Nationals and the
Multinationals.
Source: PPMA (Pakistan Pharmaceutical
Manufacturers Association) website
http://www.ppma.org.pk/PPMAIndustry.aspx
 Pakistan meets 80% of its domestic demand
of medicines from local production and 20%
through imports. The pharmaceuticals market
size is Rs. 70 Billion (US $ 1.2 Billion),
approximately. The market for
pharmaceuticals in Pakistan has been
expanding at a rate of around 10 to15% since
last few years.
(Subzwari & Khan, Spring 2009)
The number of pharmaceutical units
set up in different provinces of
Pakistan are as under:
UNITS LICENSES
PROVINCE N NMC TOTAL FOR BM/SM RP TOTAL
Punjab 191 05 196 191 13 2 206
Sindh 86 23 109 106 16 0 122
NWFP 43 00 43 43 00 0 43
Balochistan 05 02 07 06 01 0 07
AJK 03 00 03 03 00 0 03
Total 328 30 358 349 30 2 381
N=National For=Formulation RP=Repacking MNC=Multi National Company
BM=Basic Manufacture SM=Semi Basic Manufacture
 Presently 358 pharmaceutical manufacturing
units including 30 of multinational origin are
producing drugs. The major players in this
sector are the multinational companies
accounting for almost 55% of the
pharmaceutical business in Pakistan.
(Memon, 2009).
 The total medicine sales in Pakistan was of
the order of Rs. 136 billion in 2009 projected
to increase by 10% to Rs. 154 billion in 2009
(Business Monitor International [BMI], 2009).
 Pakistan meets 80% of its demand from local
production while 20% of the medicines are
imported. The local production however is
largely dependent on imported raw materials
as almost no raw materials are produced
locally (Pervez, 2008).
 Research Aim

The main focus of this paper is to enumerate

Legal and ethical issues in marketing of
pharmaceutical and what are different ways
for the Regulators and pharmaceutical
companies to address these issues effectively.
 Research Objectives
To suggest a workable model for regulating
marketing practices in the Pharmaceutical
industry in Pakistan.
 Methodology and Methods

Interviews of industry experts of the subject

were carried out in order to achieve research
objectives.
Issues Identified by Industry
Experts.
 Counterfeiting.

Counterfeiting is billion dollars market and these people target

those molecules and medicines which are too expensive for
example the growth hormone, the packaging of growth hormone
was very similar to the original drug but it contained water instead
of growth hormone injection. The water wont damage any person
but it wont benefit either. Actually dealers are involved in this
process; those black sheep give them very much commission that
even if they sell four or six items they can earn handful money. This
is happening because we dont have a strong regulatory structure
which has more vigilance and marketing surveys especially when
new drugs arrive in the market.
From Interview of Mr. Sultan Ghani, Consultant Director for quality
and regulatory affairs, Getz Pharma. Mr. Sultan Ghani worked with
Canadian FDI for 39 years. He also worked with WHO on different
international projects on health.
 It has been estimated that 40-50% of all
medicines marketed in Pakistan qualify for
counterfeit drugs by WHO definitions
(Gibson, 2004).
 It has been estimated by World Health Organization
(WHO) that, Pakistanis spend 77 percent of their
budgets for health on the medicines, 50% which are
fake or unfit for human consumption. About 40 to 50
percent of available medicines in Pakistan are
counterfeit and our country is ranked 13th in the world
for counterfeit drugs. Counterfeit and substandard
drugs are rampant in urban and even more in rural
areas.
Source: 40% of all medicines in Pakistan are fake. Daily times, March 09,
2006. Available from:
http://www.dailytimes.com.pk/default.asp?page=2006\03\09\story_9-3-
2006_pg7_60
 Outdated Regulations
The regulation currently being enforced is the
1974 Act.
This does not provide for the new
developments such as Xenotransplantation
or clinical trails.
 Inadequate Laboratories
Quality assurance
Accreditation and Affiliation of Labs
 Incentives to Doctors
A recent study by three US economists found
that a doctor receiving payments from a
pharmaceutical firm was more than twice as
likely to prescribe its drugs, compared to
doctors receiving no payments.
 This paper will be limited to explore the
incentives to doctors, their prescribing habits
and how this can be regulated
 On the other hand
Tom Stossel, a doctor and a professor of
medicine at Harvard, says medicine is
"incomparably better" today than it was 50
years ago, and that "all of this is thanks to the
tools that physicians have gotten from
industry".
 Medical Representatives
Training!
Regulated but not enforced.
When asked, a Sales Manager for a company
selling nutritional product in Karachi said
No its part of their job. And if both the people
want it, then there is nothing illegal about it.
Thats why its called an activity
 Michael Oldani, who worked as a rep for Pfizer
before becoming a medical anthropologist,
has described how offering food and drink -
free bagels, lunches and coffee coupons - was
a favorite strategy.
 The Sunshine Act
Under the little know provisions of President
Barack Obamas healthcare reforms, called the
Physicians Payment Sunshine Act, industry
payment to the doctors will be published on a
public website. This was enacted in 2013.
 A similar proposal was made by the SECP in
September 2013.
SECP sent a draft Code of Marketing Practices
for the Pharmaceutical Industry to the
ministry of health suggesting that DRAP enact
the Code which mainly relates to restriction of
gifts to healthcare professionals .
Disclosure requirement?
 Suing the Doctor
Litigation against doctors who have
committed medical negligence, over
prescription or wrong prescription of drugs.
The litigation process and the Courts are not
very efficient in safeguarding the rights of the
patients.
Need for specailized courts and summary
proocedure.
 Average disposal time for commercial case: 57
months.
123,000 cases pending in subordinate courts in
Sindh.
27,000 cases pending in SHC.
Estimated 880 days to enforce a contract with
55 procedures (WB Report).
 Role of the Regulators
Drug Regulatory Authority of Pakistan
Securities and Exchange Commission of
Pakistan
Federal Board of Revenue
Other Bodies i.e Pakistan Pharmacuetical
Manufacturers Association.
 Advertizing
some countries like US, Can do the promotion on television of
prescription drugs but they would say you have to consult your doctor.
Canada will never allow but due to close borders and accessibility of
electronic media consumers watch American channels. Canadian laws are
little tough but it is very interesting that the Act of India, Pakistan, Canada
is similar because they were the British colonies. We follow British-India
Act especially for pharmaceutical and Canadians follow British North
America Act. There are common elements in both these acts because these
are the British Acts like duties and responsibilities of inspector, fines and it
is cheaper to pay fine than to correct the practice. You should focus over all
on safety and quality which also includes legal promotion specifically
illegal.
Syed Sultan Ghani
Director Compliance, Getz Pharma
 Waseem Akram as Diabetic Ambassador
There are two companies which have used him
one is Rosh for their gluco-meter and other is
Avantis for their anti-diabetic products. In the
same way for zinc Abbott used Mah Noor. You find
other campaigns as well like on hormones for
instance female hormonal deficiency is discussed
usually and male hormonal deficiency is not
discussed. This is the area in which Qazi Wajid is
used. But the magnitude of these campaigns is
very low; hence its recall is low as well.
Community Pharmacies in Pakistan
The paper concludes that although laws exist,
but due to lack of accountability and weak
regulatory framework their proper
implementation is not witnessed. Moreover,
due to lack of research and evidence related
to problems in dispensing practices in
healthcare system of Pakistan, the
counteractive actions for resolving these
problems are limited.
(Azhar Hussain 2013).
 Community Pharmacies
Regulation needs to be formulated with a
focus on improving doctors prescribing habits
by using Pharmacists who are trained and
licensed.
 Single legal framework is not suitable for
across the board implementation.
The code needs to be flexible and ensure the
best products to be made available to the
patient.
Training and licensing of Medical
Representatives and Pharmacists according to
International standards.
Thank you.