The National Association of Pharmaceutical Manufacturers (NAPM) was established in 1977 as A Section 21 Trade Association which. It is a voluntary, non-profit organisation consisting of South African and Generics based Pharmaceutical manufacturers and distributors. The NAPM has a diverse membership comprising of 18 companies. Part of the NAPM’s function is to ensure that the sector plays a constructive role in our country’s economic growth, development and transformation and thereby create an environment in which the sector can thrive, expand, be competitive and enhance access of medicines to all of our country’s citizens.

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LINKING OUR MEMBERS
TO INDUSTRY NEWS AND VIEWS
NOVEMBER 2015
NAPM
REVIEW

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2 IGBA 2015- special report
10 New findings on generics usage in SA indicate
significant savings on drugs expenditure
12 Bridging the Skills Gap
14 Generic Industry takes a stance on Trade Principles
18 Have the IP reforms stalled?
20 Study shows working moms’ mental health deteriorating
22 Manufacturing Indaba to encourages local production
23 SAPHRA becomes a reality
24 MC Pharma Group
25 Sunpharma
26 Regional Pharmaceutical Production
28 Notes
CONTENTS
KEY TRENDS
SPECIAL REPORT
INSIDE

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On September 16-18, 2015 the International
Generic Pharmaceutical Alliance (IGPA)
held its 18th Annual Meeting in Toronto,
Canada. IGPA is composed of members:
the Canadian Generic Pharmaceutical
Association (CGPA-Canada), the European
Generic and Biosimilars Medicines Association
(EGA-Europe), the Generic Pharmaceutical
Association (GPhA-USA), the Japan Generic
Medicines Association (JGA-Japan), the
Jordanian Association of Pharmaceutical
Manufacturers (JAPM-Jordan), the National
Association of Pharmaceutical Manufacturers
(NAPM-South Africa), and the Taiwan Generic
Pharmaceutical Association (TGPA-Taiwan)
with the generic medicines associations of
Australia, Brazil, and Mexico as Associate
Members.
Through its constituent member associations,
the IGPA maintains constant dialogue with the
International Conference on Harmonisation
(ICH), the World Health Organization (WHO),
the World Trade Organization (WTO), the
World Intellectual Property Organization
(WIPO), and other international organizations.
This year IGPA’s Chair and President was Jim
Keon, CGPA’s Chair and President, who kicked
off the main conference on September 17.
Keon announced that in recognition of the
increasing importance of biosimilars, IGPAå
will soon change its name to the International
Generic and Biosimilars Association (IGBA).
The Alliance recognizes that the success of
generic and biosimilar markets depend on
their reference innovator products and that
specialty pharmaceuticals have increasingly
become part of that picture.
Following a global dive into the generics
market by Alan Sheppard, Principal, Global
Generics, IMS Health, a Keynote Address
followed by Eric Hoskins, Minister of Health
and Long-Term Care, Province of Ontario.
Hoskins thanked the generic pharmaceutical
industry for helping to provide quality
medicines to those in need and to help with
the quality of life by bringing healthcare costs
BY KATHLEEN DOOLEY, BRIAN MALKIN
MCGUIREWOODS LLP
SPECIAL REPORT
IGPA 2015
FOCUSES ON BIOSIMILARS,
QUALITY, AND HARMONIZATION
IN TORONTO-9/25/2015

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down. Hoskins said that he is working with
the other Canadian provinces to increase use
of generic medicines, recognizing that they
work the same but cost less due to increased
market competition. Hoskins explained that
in Canada there is a tiered pricing for generic
products based on competitor products and
that there is an increasing need to work on
drug substitution lists.
Key industry leaders from North America,
Europe, and regional snapshots of ASEAN
and the Middle East/North Africa, provided
views of generic medicinal products
expanding worldwide. In the U.S., approval
times are starting to improve under the
Generic Drug User Fee Act (GDUFA) but
not as fast as predicted and with some
slow downs based on an ever-increasing
application load. In the European Union,
sustainable pricing policies are needed,
and there is good data to confirm that
biosimilar products are as safe and effective
as their referenced counterparts, suggesting
additional opportunities for substitution.
Hybrid products similar to 505(b)(2) NDAs
in Europe are becoming more popular
and further helping to fuel future growth.
For ASEAN and Middle/East North Africa
markets, there is increasing generic product
development amidst some localized concerns
of counterfeit products and recalls that affect
all segments of the pharmaceutical industry
periodically.
Howard Sklamberg, Deputy Commissioner
for Global Regulatory Operations and
Policy, FDA, discussed FDA’s new Request
for Quality Metrics Guidance issued some
Hoskins explained that in
Canada there is a tiered pricing
for generic products based on
competitor products and that
there is an increasing need to
work on drug substitution lists.
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50 days ago, and FDA’s vision that quality
metrics can predict disruptive mechanism and
prevent the recalls or shortage situations. FDA
is hoping that by monitoring drugs through
their product life cycle from innovator to
generic, FDA can identify areas of concern
and document where quality exceeds
regulatory requirements to provide not only
sticks for poor performance but carrots for
good work. The carrots may result in less
frequent inspections and shorter review
cycles for manufacturing changes, Sklamberg
suggested.
Sklamberg also said that FDA is looking for
more objective ways to measure quality that
is more obvious and fair rather than a laundry
list of findings in an inspection report. In
response to questions following the panel,
he added that FDA is looking for input to its
draft guidance and appreciates that the cost
of inspections cannot be underestimated.
Sklamberg added that FDA recognizes that
companies may paradoxically find that by
trying to avoid inspection reports they may
actually cause more errors, which is why
in part they are asking for industry input
regarding the proposed quality metrics plan.
In terms of mutual recognition of inspections
by foreign authorities, Sklamberg said that at
this point, FDA is not planning to add more
countries to the current list, in part because
FDA has found challenges with the process.
FDA has found that while countries can
share factual information about audits, the
conclusions from those audits, e.g., whether
regulatory action needs to be taken, rests
within their respective legal systems rather
than an objective result across the board.
Brendan Cuddy, Head of Manufacturing
and Quality Compliance Service, European
Medicines Association (EMA) said that
the EMA is also concerned with supply
disruptions, hoping to improve the supply
side of products, e.g., sources of active
pharmaceutical ingredients. Cuddy said that
the EMA is looking at adverse events beyond
Europe, because European medicines are
consumed outside of Europe as well, and
EMA continues to be concerned about data
integrity. The EMA is looking for convergence
to help support a more global approach to
authorization and supervision of medicines.
Yet there are issues of a lack of continuous
improvement, reduced manufacturing by
more company mergers, recalls and quality
defects rising, less investment in products,
and poor interactions between industry and
the regulator making such convergence
challenging. The EMA has witnessed known
problems in product development that still
make their way to production, leading to
shortages later and failures in technology
transfer. Cuddy asked, “Can you invest
in quality when it seems unaffordable to
compete?”, referring in part to the lack of
issue sharing between manufacturer and
supplier, e.g., manufacturers rank suppliers
internally but do not share the information
with the supplier.
Ajaz Hussain, Founder & President, Insight,
Advice and Solutions, LLC provided a
provocative view of quality culture, suggesting
that part of the issue is how predictably
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pleasure and pain. Hussain described the
“nocebo” effect, where the mere suggestion
that a patient may experience negative
symptoms in response to a medication
(or a sugar pill) may be a self-fulfilling
prophecy. This effect also makes patients
think generic drugs as less good than their
referenced counterpart, because they are
perceived as copies of an original. Hussain
sees quality by inspection as an ineffective
way for companies to comply with regulatory
requirements. In his experience, many
companies attempt to create quality with an
endless list of standard operating procedures
(SOPs) that no one understands. While
Hussain welcomes the concept of quality
metrics, he does not believe industry is
ready for FDA guidance yet. He does believe,
however, that when mistakes are made, it is
important to be transparent about them with
regulatory authorities as a first step to rebuild
trust along the road to fixing the underlying
problem.
In the next panel, three lawyers provided
perspectives on biosimilars patent litigation,
patent linkage in Korea, and developments
in antitrust competition law. Brian Malkin,
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Hussain described the “nocebo”
effect, where the mere suggestion
that a patient may experience
negative symptoms in response
to a medication (or a sugar pill)
may be a self-fulfilling prophecy.
This effect also makes patients
think generic drugs as less good
than their referenced counterpart,
because they are perceived as
copies of an original.

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6
Senior Counsel, McGuireWoods provided an
overview of approval mechanisms, patent
linkages, and patent challenge strategies for
biosimilar products in Canada, the EU, Japan,
and the United States. Malkin’s presentation
suggested that while each region may have
different mechanisms to challenge patents,
global product development models required
understanding how to locate precedent from
jurisdictions where key patents had been
challenged. Seong-Ki Kim, Partner, Lee & Ko
IP, provided an overview of Korea’s patent
linkage system, which indicated that while
there has been some progress to develop
patent linkage in Korea, more progress
would be welcome to the generic industry.
And William H. Rooney, Partner, Willkie, Farr
and Gallagher LLP, explained the concept of
“pay-for-delay” and “scope of the patent” in
the context of antitrust litigations involving
pharmaceutical products.
The following day featured a panel of
chief executive officers from a variety of
pharmaceutical companies of different
sizes and focus areas. Common themes
included ongoing industry consolidation and
increasing concern about the supply chain
and its impact on product quality. In the U.S.,
CEOs expressed disappointment with initial
returns from GDUFA, which in part occurred
because of an underestimation of how large
an overhaul FDA’s operational systems
required. While ICH and other internationally-
oriented bodies have made progress with
innovator products, the CEOs observed that
there has been little harmonization around
bioequivalence standards. As a result,
generic companies are forced to develop
multiple bioequivalence approaches for
products, requiring duplicative but somewhat
different biostudies, and largely unnecessary
biostudies, at a cost to development.
Regarding biosimilars, there appeared to
be consensus that FDA’s proposed non-
proprietary naming model to include the same
core name with a four-letter nonsense code to
differentiate reference and biosimilar products
would create more barriers for acceptance
of biosimilars. For the biosimilars industry
to succeed, there needs to be more market
uptake, e.g., infliximab in Canada only has
sales around $7,000 – clearly not a workable
model.
Next, an IGPA panel provided an overview
how IGPA has been working to address
trade barriers and promote foreign market
access for generic and biosimilar medicines.
Jim Keon explained that until recently,
The CEOs observed that there
has been little harmonization
around bioequivalence
standards. As a result,
generic companies are
forced to develop multiple
bioequivalence approaches for
products, requiring duplicative
but somewhat different
biostudies, and largely
unnecessary biostudies, at a
cost to development.

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the generic industry has gotten to the
trade negotiations table late, resulting in
imbalances in patent linkage systems and
intellectual property rights that favored
innovator products. IGPA has assembled a
team dedicated to addressing trade relations
in a more coordinated manner, Keon said,
which it hopes can not only benefit small
molecule generics but a developing biosimilar
industry make inroads for increased market
acceptance and product development.
IGPA is also involved in the Trans Pacific
Partnership (TPP), which represents 40%
worldwide trade, and is a living agreement
where more countries can join in such
discussions as patent linkage and market
protection, e.g., exclusivities. Adrian van den
Hoven, Director General, EGA, then described
how IGPA and its members have been getting
involved in the Transatlantic Trade and
Investment Partnership (TTIP) and how it may
translate into better access to generic, value-
added, and biosimilar products, which are
EGA’s focus areas.
The final main panel included a regulatory
discussion of biosimilars from Dr. Sue Lim,
Senior Staff Fellow, Therapeutic Biologics and
Biosimilars Team, FDA, Dr. Elena Wolff-Holz,
Paul Ehrlich Institute, Member of the EMA
Biosimilar Medicinal Products Working Group,
and Dr. Ivana Knezevic, Scientist, Group
Leader, Norms and Standards for Biologicals,
Department of Essential Medicines and Health
Products, WHO.
Lim explained FDA’s general plan for
reviewing biosimilars. Interestingly, Lim
noted that the only approved biosimilar,
Zarxio® no longer had identical indications
to its reference product, because a new
indication had been added to the referenced
product since approval, which would require
a supplement to add the new indication. Lim
said that FDA plans to issue guidance for
interchangeability, labeling, and statistical
approaches. Lim also described the goal
behind the recent nonproprietary naming
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proposal, which FDA believed would prevent
inadvertent substitution and facilitate
pharmacovigilance by encouraging routine
use of designated suffixes while avoid
potential inaccurate perceptions of safety
and effectiveness differences of biological
products based on the licensure pathway.
When asked about FDA’s proposed naming
policy and whether NDC codes were
suggested as a possible suffix, Lim said that it
was considered, but FDA did not think it was
adequate and could not comment further on
it. Lim said that in the U.S., FDA heard that
non–proprietary naming was used more than
brand names, which is why FDA believes it is
more critical for pharmacovigilance.
Lim suggested that biosimilar sponsors
come to FDA with a plan to address product
differences in advance–“don’t just hope for
the best.” Lim also suggested that the sponsor
be transparent and share feedback from each
regulatory authority, as questions to seek
clarity and note program differences. Lim
said that while sponsors may request parallel
scientific advice for biosimilar development,
while regulators from different countries may
strive for alignment on scientific concepts,
she cautioned that they may not be able to
harmonize advice and will note similarities and
differences.
Wolff-Holz picked up on Lim’s comment that
while there has been U.S. and EU convergence
on the step-wise process and totality of
circumstances, there are still regulatory
differences. In the EMA, for example, there
is alignment with FDA that there is no
regulatory requirement for biosimilarity after
granting authorization, e.g., like with Zarxio®,
indications added to the reference product
after approval of the biosimilar are not
automatically added to the biosimilar product,
even though there may be that option with
extrapolation in a supplemental application.
The EMA appears to have a different plan for
pharmacovigilance tied to the brand name
and batch number, whereas FDA appears to
be looking to nonproprietary naming, which
goes against EMA policy to avoid proliferation
of local drug substance nomenclature. And
the various regions also differ on what
is considered a biosimilar product, e.g.,
enoxaparin is regulated as a drug by FDA
but as a biologic in the EMA and by Health
Canada.
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Picture of the participants
in the presentation of Trade
Principles at the IGBA
meeting in Toronto.
L to R Vivian Frittelli
(moderator) Jim Keon
President of Canadian
Generic Association, Terry
Creighton Vice President
International Affairs (teva),
Adrian Van den Hoven
Director General European
Generics association
SPECIAL REPORT
When asked about the difference in
extrapolating indications for infliximab in
the EMA and Health Canada, Wolff-Holz
noted that while both agencies agree in the
concept of extrapolation, there were different
scientific viewpoints on a single test for a
possible mechanism of action for irritable
bowel disease result that showed perhaps a
20% difference. The EMA and other countries
where this product is approved thought that
in the totality of the data, this difference
was not clinically meaningful, but Health
Canada differed. Wolff-Holz added that
Health Canada may ultimately reach the same
conclusion once Celltrion provides additional
data, which has been requested.
Knezevic explained how the WHO gets
involved in biosimilars and biological
reference materials and standardization
of assays and quality control tests to help
standardize biological products worldwide.
From her viewpoint, one of the dangers
has been that in some countries, biological
products are called “biosimilar” when there
is no reference biological product in that
country, calling this a “fake biosimilar,”
where the term “biosimilar” should not be
used. Regarding the extrapolation issue
for infliximab, Knezevic agreed that each
regulatory authority has right to make its own
determinations but thought it is still useful to
share information.
In the concluding remarks, IGPA appointed
its new Chair and President, Vivian Frittelli,
CEO, National Association of Pharmaceutical
Manufacturers (South Africa) and venue for
next year, Orasac-Dubrovnik, Croatia, held
jointly with the EGA’s Annual Meeting, from
June 8-10, 2016. See you there!

12. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
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A study conducted recently on behalf of
the National Association of Pharmaceutical
Manufacturers (NAPM) comparing the cost
of generics versus originator drugs has
found that the difference in price of the 200
most prescribed medicines within the private
sector has risen to a whopping 56.1% in
favour of generics.
Vivian Frittelli, CEO of NAPM, said: “Since
2010, we have seen a steady increase in the
cost advantage of generics over originator
drugs. Considering that production
standards and manufacturing costs for both
original and generic medicines are similar,
these findings are significant.”
According to IMS Health, a global organisation
which tracks data at sales level, generics
account for about 65% of all items dispensed
in SA’s private sector yet cost only 40% of the
R22 billion expenditure on drugs.
Using claims data from more than 1 million
medical aid members, Mediscor, a pharmacy
benefit management organisation, puts
generic usage at 56%, and growing. However,
as the NAPM study emphasises, South Africans
could be enjoying substantially greater
savings if more generics were used. Of the
expenditure on medicines purchased, 18%
went to originator drugs for which generic
alternatives are available. Based on data
gleaned from IMS Health, every 1% increase
in the use of generics would save consumers
around R270 million.
New findings on generics
usage in SA indicate
significant savings on drugs
expenditure
Increase in generics usage
slowing down expenditure on
drugs
Widening gap between prices of
generics and originator drugs
Utilization of generics is
increasing
Choosing generics over
originator drugs could save South
Africans a further R4 billion p.a.

13. 11
GENERIC USAGE IN SA
“These savings would enable medical
schemes to offer improved benefits or
to curb increases in premiums to their
members. They also provide a direct benefit
for consumers paying for medicines out of
pocket or through their medical scheme
savings accounts,” said Frittelli.
Discovery Health’s publication, ‘Medicine
Summit Journal 2015’, using data from
medical aids administered by Discovery,
supports the NAPM findings and reports
a 58.8% utilization of generics by volume
and 46.6% by value. This publication also
indicates that 65% of generic medicines
are priced at 40% below their originator
equivalents while at least 48% of generics
are priced at 50% or more below their
originator equivalents.
In practical terms, for a patient with Asthma
and Allergic Rhinitis (hay fever), complicated
once by a fungal infection in the throat due
to inhaler use, the savings over a year could
be nearly R4 000 if generics were used.
The trend in SA follows that of the UK
where more than two thirds of all medicines
dispensed by the NHS are generics yet
cost only around 29% of the NHS drugs bill,
and the USA, where nearly eight out of 10
prescriptions filled are for generics, causing
expenditure on drugs to slow despite an
increase in the price of prescription drugs.
“As life expectancy increases and the cost
of medicines escalates, the importance of
the generics industry is being highlighted
as it allows more people greater access
to healthcare. The value proposition
presented by generics cannot be disputed,”
commented Frittelli.
GENERIC FACT SHEET
Generics are drug products that are
comparable to originator or branded
drug product in dosage form, strength,
quality and intended use.
Generic medicines contain the same
active ingredient and are as effective as
the originator or branded equivalent but
in most cases cost much less.
When a generic medicine has been
approved by the MCC, it has met the
standards required on aspects such as,
strength; quality; identity; and, potency.
KEY TRENDS
60
50
40
30
20
10
0
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
% Discount vs 2015 Generic Price
54.5
45,2 45,1 44,3
52,6
56,154,5
51,952,5
50,1
45,744,9

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The United Nations Industrial Development
Organization was the main sponsor of a two
day workshop on “Bridging the Skills Gap
for the Pharmaceutical Industry in South
Africa” which was held at the end of May
2015 in Midrand.
The report of the workshop has been
produced recently and describes outcome
of the consultative forum. The forum was in
answer to a publication of the Department
of Trade and Industry which reported on the
status of the Industrial Policy Action Plan
(IPAP). The purpose for the formulation of
IPAP is to improve economic growth, skills
development and the transformation of
Industry in South Africa
In particular the publication highlights a few
short comings of the SA Pharmaceutical
Industry. The capacity reduction of
pharmaceutical manufacturing during the first
decade of this century is partly responsible
for the trend that more than 65% of medicines
needs are imported leading to the situation
that the Pharmaceutical Industry accounts for
the fifth largest SA current account deficit.
These elements place the long-term security
of medicine supply under threat.
The main purpose to be addressed by the
forum was to assess the human capital
available and relevant for the development of
the pharmaceutical Industry.
The government was represented by three
departments- Trade and Industry, Higher
Education and Training and Health. The four
statutory authorities included the Medicines
Control Council, the Pharmacy Council, and
Medical Research Council. Four trade and
professional associations and ten universities
that offered pharmacy and natural science
courses also attended.
The methodology of the workshop was
to assess the skills required along the
pharmaceutical value chain. This resulted in
seven working streams
1. Clinical research
2. Production of raw materials
3. Production of finished Pharmaceutical
Products
4. Quality systems
5. Regulatory systems
6. Natural sciences
7. Distribution
The chairpersons of each group presented the
feedback of their workshops to the plenary
audience.
Seven strategic objectives were devised as a
result of the deliberations
1. Establishment of a formal forum for key
stakeholders to hold on going consultations
and exchange ideas.
2. Government to devise a policy for growth in
Bridging the
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15. 13
IGPA 2015
the pharmaceutical industry. It is important
that the government departments show
coherence in their strategic intent for the
industry.
3. Grow capacity for local production of
active pharmaceutical ingredients (API).
A possibility is to convert some chemical
facilities into API manufacturing facilities.
4. Strengthen the capacity of academic
institutions to gain exposure to the
pharmaceutical industry.
5. Assist academic institutions with financial
resources and provide work integrated
learning. Provide work experience for
students.
6. Introduction of modules on quality systems
at under-graduate levels as the regulation
of the pharmaceutical industry warrants an
understanding of such systems.
7. Strengthen the regulatory systems through
post-graduate specialization programmes.
This is one of the aspects the Institute of
Regulatory Sciences hopes to achieve.
Despite the emphasis on human resources
throughout the deliberations, many of the
other challenges facing the pharmaceutical
industries were discussed.
The opening presentation given by Dr
Skhumbuzo Ngozwana highlighted that if
the pharmaceutical industry was to grow
there should be a deliberate governmental
determination to offer assistance through
means other than tax incentives. Examples
of this are the successes achieved by
Singapore. And the policies adopted by
the government of Ethiopia in developing
pharmaceutical manufacturing capacity in
East Africa. Dr Ngozwana suggested that in
South Africa’s development we should look
at the manufacture of niche products such
as Biosimilars. Originator biotechnology
products are recognized as being among the
cost drivers of medicines expenditure.
At the conclusion of the session a joint
pharma industry working group was
nominated at the end of the conference.
This group would provide input to the Human
Resources Development Council.
MEMBERS OF THE WORKING GROUP ARE
Professor Douglas Olivier
of North West University
Professor Chris Stubbs,
Executive at Aspen Pharmacare.
Dr Vassie Naidoo,
lecturer at the University of Kwa-Zulu natal.
Mr Phasha Mogologolo,
Executive at PBM Pharmaceuticals
Dr Desmond Johns,
Project Manager at IRS
Dr rolf Becker,
executive Director at SA Council for Natural
scientific Professionals
Mr Wouter van Rensburg,
Director at Adcock Ingram
Ms Swasthi Soomaroo,
Director at the Department for Trade and Industry
Mr Mothobi Godfrey Keele,
Project Co-ordinator at UNIDO.
KEY TRENDSBRIDGING THE SKILLS GAP KEY TRENDS

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Addressing a session called “Principles
to Foster Trade in Generic and Biosimilar
Medicines,” at the World Trade Organization’s
public forum in Geneva from 30th September
201 to 2nd October 2015, representatives
from the International Generic and Biosimilar
Medicines Association IGBA said that Free
trade agreements should include incentives
for generic and biosimilar medicines to
provide early access of medicines to patients.
Speakers commented on the importance of
generic and biosimilar medicines for access to
health, in particular in developing countries.
On the panel, Murray Aitken, executive
director of IMS Institute for Healthcare
Informatics, a global information and
technology services company, said most
of the global burden of diseases can be
addressed by existing medicines.
Today, he said, generic medicines account for
over 80 percent of the total medicines volume
globally. Generic medicines play a vital role in
controlling the costs and increasing access to
affordable medicines, he added.
IMS reports the global generic market reached
US$194 billion in 2014, and, 43 percent of
which are from branded generics and 57
percent unbranded generics. Global trade is
vital for the generic sector, he said.
Jim Keon, former chair of the IGPA
and president of the Canadian Generic
Pharmaceutical Association, said many rules
around trade and access to markets are
imposed on industry. The generic industry has
been active in many negotiations, but mainly
reactive, he said.
Four main areas of concern for the generic
industry are:
• Fostering regulatory convergence of the
requirements for the approval of generic
and biosimilar medicines, and recognition
of compliance inspections through the
establishment of frameworks providing for
regulatory cooperation;
• Ensuring that the regulation of IPRs in trade
agreements does not lead to excessive IP
standards that delay access to generic and
biosimilar products;
• Establishing an appropriate framework of
Generic Industry takes a
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17. 15
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pro-competitive provisions to prevent IPR
abuse/misuse, and;
• Establishing an appropriate framework
for incentivizing generic and biosimilar
medicines’ market access.
Stringent IP provisions can prevent
competition and delay the entry of generic
and biosimilar medicines into the market,
according to Keon.
According to an IGPA document, “the
increasing push for the inclusion of more
extensive IP protection in FTAs” stands to
alter the balance established by the WTO
Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS).
IGPA members wish that the TRIPS standards,
with its flexibilities, would be taken as
the basis for negotiations on free trade
agreements’ IP chapter, according to Keon.
“The IGPA believes that the standards on
patentable subject matter, novelty, inventive
step, and industrial applicability, as well
as disclosure, as reflected in the TRIPS
Agreement, are instrumental to ensure the
proper functioning of the patent system…,”
the IGPA document said.
Early disclosure and work on a patent
is critical to ensure timely generic and
biosimilar market entry, Keon said. Additional
stipulations in FTA’s could hamper local work
in launching a generic or biosimilar in an
export country as well.
Moreover, FTAs should not provide longer
data exclusivity periods for biological
medicines than for small molecule drugs,
he said. FTAs should not seek to extend the
terms of patent rights, he added.
Patent and test data should not be made
subject to border measures and criminal
enforcement, he said. In particular, border
measures should not apply to goods in
transit.
Regulatory convergence refers to the same
information and data being required by
medicine regulatory authorities. It is unrealistic
for every application process to be the same.
GENERIC INDUSTRY TAKES A STANCE KEY TRENDS

18. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
16
According to Keon, regulatory
convergence is desirable for
generic companies. In particular,
the single development for
generic and for biosimilar
medicines, and mutual recognition
of good manufacturing practices
inspections would be needed.
Single development of generic and biosimilar
medicines would lead in particular to the
reduction of clinical development costs, the
opportunity to re-invest potential savings,
and the reduction of unethical repetitions of
clinical trials, Keon said.
Countries should provide incentives
for generic and biosimilar medicines
manufacturers to enter their markets, he
argued, such as incentives stimulating
competition and innovation, fostering
savings for national health care systems and
facilitating access to affordable medicines.
Such incentives could be done through pricing
and reimbursement policies.
Incentives to generic and biosimilar medicines
should balance the protection enjoyed by
originators through patents and other IP
rights, Keon said.
David Gaugh, senior vice president, sciences
and regulatory affairs, Generic Pharmaceutical
Association (US), commented on the Trans-
Pacific Partnership (TPP). It gathers 12 Pacific
Rim countries, representing some 40 percent
of the global gross domestic product and 800
million people, he said. Other countries might
be interested in joining, he said, in particular
South Korea, the Philippines, Thailand, Costa
Rica, and Taiwan.
On 1st October, chief negotiators and
ministers met in Atlanta (US) for what was
hoped to be the “final round” of the TPP, he
said. According to news sources, one of the
key sticking point at the end was terms for
biosimilars.
The TPP provides for extensions of patent
terms, delaying both the issuing of patents
and the regulatory approval process, Gaugh
said.
The TPP fails to provide a system that affords
incentives for challenging inappropriate, weak
patents, or the ever-greening of patents, he said.

19. 17
IGPA 2015
He also said the TPP could put at
risk the future and sustainability
of global generic and biosimilar
industries, if it there is a lack of
balanced provisions, he added.
Adrian Van Den Hoven, director general,
European Generic and Biosimilar Medicines
Association, remarked on the very high cost
of developing biosimilars. Biosimilar products,
also called follow-on biological products, or
similar biotherapeutic products, are defined
by the WHO as: “a biotherapeutic product
which is similar in terms of quality, safety
and efficacy to an already licensed reference
biotherapeutic product,” (IPW, Public Health,
23 January 2015).
In particular, the process to prove similarity
with the originator biopharmaceuticals is
extremely costly, he said.
He said the members of his association had
to buy biopharmaceutical products, which
are extremely expensive at the scale of a
clinical trial covering about 300 patients
to compare results with the biosimilar. This
comes at “huge expense,” he said. A lot of
developed country patients have no access to
biosimilars, he said, and the situation is much
worse in developing countries.
Conclusion of Trans Pacific Partnership
Agreement.
On the Sunday 4th October, two days
after the conclusion of the WTO Public
forum the TPP was agreed by 12 Trade
ministers meeting in Atlanta, Georgia, USA.
Negotiations had commenced in November
2009. The TPP was the main stimulus for
the IGBA to develop the Paper on Trade
Principles. Among other conditions the US
representatives were negotiating to obtain 12
years exclusivity for biosimilar medicines.
In the end, ministers reportedly found balance
on Intellectual property for biologic drugs,
a key area of interest for the United States,
by establishing rules which ensure incentives
for developers of new cures while providing
access to these cures by patients throughout
the region. The agreement provides for a
minimum five year period of data exclusivity
in all member economies, plus an additional
three years of protection by other means. This
indicates the influence FTA’s have on delaying
generic and biosimilar launches.
The full text of the TPP has not yet been
made available to the public but is reported
to span 30 chapters.
GENERIC USAGE IN SA KEY TRENDS

20. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
18
The draft policy on Intellectual Policy (IP) in
South Africa issued in July 2013 for comment
seems to have stalled. Although comments
on the policy closed in October 2013 the
situation remains in flux and although there
were indications from various quarters that
the policy was submitted to cabinet no final
document has emerged.
Currently patents are granted on completion
of the correct form and payment of the
applicable fee. However, the draft IP policy
makes provision for an examination office
which will assess applications before granting
patent protection. This is of particular
importance to the generic medicines industry
as many product launches are delayed due to
originator strategy of ever-greening patents.
Ever-greening involves extending patent
protection by making changes to the product
in question. These amendments usually
involve the change of manufacturing process,
which results in the production of the same
product with no extra benefit to the patient.
The only way for challenging the “automatic”
patents to see if they conform to the novelty
and patentability conditions is to seek a court
review. Legal action is expensive and can cost
millions of Rands in presenting expert legal
and technical witnesses. Combine this with
the cost of Senior Counsel and the delay in
court schedules and there is little incentive to
challenge patents in South Africa.
The Free Market Foundation have weighed
in on the discussion with a series of opinion
pieces in business publications with a fairly
standard comment that the draft policy will
cause innovators not to be rewarded for their
efforts and thus discourage good ideas. In
addition to this the Foundation maintains
that there is not the expertise to staff an
examination office and it will take time to
build up the skills. The retort to this is that if
you do not start you will never build the skills.
Health activists such as Mediciens Sans
Frontiers (MSF), Treatment Action Campaign
and Section 27 have expressed their outrage
that two years have passed without a final
policy being endorsed. The delay has negative
implications for the provision of affordable
medicines for the South African population.
In January 2014 the Mail and guardian
newspaper uncovered an alleged plot by some
members of the Innovators Pharmaceutical
Association of South Africa (IPASA) intending
to establish a fund to work against the
proposals contained in the draft policy. In
response to the newspaper story, the Minister
Have the
IP reforms
stalled?

21. 19
IGPA 2015
of Health Dr Aaron Motsoaledi described
the alleged campaign as a” satanic plot” and
“genocide “. Consequently some members of
IPASA terminated their membership.
A report in the Business day in August
2115 stated that the American Chamber of
Commerce in South Africa (AMCHAM) has
urged the US Trade Representative (USTR)
to use its review of the African Growth and
Opportunity Act (AGOA) to pressure the SA
Government to change the draft IP policy in
favour of US based companies. The majority
of US pharmaceutical companies represented
in South Africa are innovator companies,
known colloquially as “big Pharma’. AGOA
allows African countries to enjoy favourable
of no tariffs when exporting to the USA.
The Director General of the Department
of Trade and Industries, Lionel October,
maintains that in formatting the policy the
department will not pander to any “side”.
The AM Cham submission to the USTR
alleges that the draft policy as presented
will” weaken current standards”. This beg the
questions “what standards?’ where there is an
unfettered access to obtain a patent.
The grouping of Civic activists has submitted
a joint memorandum to USTR countering
the AMCHAM’s assertions. It was reported
in Business Day that TAC spokesperson
Marcus Low said “in the context of what we
have seen before it is not surprising that
they are asking the Trade Representative
to do something inappropriate”. The NAPM
position is supportive of the Draft Policy. We
are in support of an examination office that
can make a decision before the granting of
a patent application as well as a mechanism
to challenge existing patent without
approaching the Courts.
In order to overcome the inexperience of
an examination’s office South Africa could
utilize assistance and rulings from foreign
jurisdictions such as the European Union.
The NAPM position is
supportive of the Draft
Policy. We are in support
of an examination office
that can make a decision
before the granting of a
patent application as well as
a mechanism to challenge
existing patent without
approaching the Courts.approaching the Courts.
HAVE IP REFIORMS STALLED? KEY TRENDS

22. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
20
Study shows
working moms’
mental health
deteriorating
The demands of keeping a job, raising
children and running a home are driving more
working moms in SA to the brink of a nervous
breakdown according to a just-released poll
by a leading pharmaceutical firm specialising
in the treatment of depression and anxiety.
Wilmi Hudsonberg, spokesperson of Pharma
Dynamics said the company conducted the
survey to determine the extent to which
additional burdens, such as career demands
have on the mental well-being of working
mothers in the country.
“Being a mother is the hardest job you can
have, but being a working mother, particularly
in today’s society, is that much harder.
Between the stresses of work, traffic, job
advancement and motherhood – keeping
a house, preparing meals, taking care of
children and sometimes elderly parents too –
there is often no reserve left for mothers on
the job,” she says.
Pharma Dynamics’ survey, which polled
900 working moms in the country between
the ages of 25 and 55 found that 38 % are
frequently stretched to breaking point with
many spending up to 80 hours a week on
work and home responsibilities. Sixty percent
have to regularly catch up on work at night or
on weekends.
While more than half of working moms (55
%) indicated that their employers offered
at least one family-friendly perk, such as
flexible scheduling, they said the following
would make their lives significantly easier as a
working parent.
• An employer that focuses on being more
output-based than having you sit behind a
desk for eight hours (51 %)
• Working from home on some days, which
means you gain hours by not having to
commute to and from work (40 %)
• Better part-time or half day work
opportunities (40 %)
• More help with household chores (37 %)
• More help with children (24 %)
Hudsonberg points out that most jobs are
made for people who have no caregiving
responsibilities, which inevitably means
that working moms do most of the

23. 21
IGPA 2015
accommodating. With the impossible
schedules modern mothers manage,
something inevitably has to give and the
price they pay is often their health.
Since becoming a working mom,
most respondents said they suffer
from at least one health problem.
Among these include headaches
(56 %), chronic fatigue (47 %),
unhealthy weight-loss or gain (47
%), anxiety
(45 %), insomnia (34 %), being
more prone to colds and flu (33
%) and depression (31 %).
High ongoing stress levels have been linked
to mental illness such as depression and
anxiety and can also lead to substance abuse
or becoming suicidal, which is what the
prevention-minded pharmaceutical wants to
curb.
While the overwhelming majority of working
moms (69 %) said they work solely because
they need the income, almost a third said
they also do so for mental stimulation and
enjoyment. The reality is that our economy
has adjusted to two-income families which
means being a stay-at-home mom is
increasingly becoming a luxury.
Hudsonberg says working moms are often
riddled with guilt and spend nights awake
worrying about how they can succeed at
the office and at home, and whether their
children will resent them for their decisions.
They want solutions to the anxiety they feel.
“While employers still have some way to
go in providing benefits and options to
make a working mother’s life easier, it’s
important for moms that find themselves
in this situation to redefine the concept of
‘doing it all’ by asking for help and to stop
comparing themselves to other mothers
who seemingly have it all. Also be honest
with your employer about your needs and
be prepared to meet them half way. Bear in
mind that not every company will be able to
accommodate your needs – the industry and
type of job you do largely determines the
kind of family-friendly benefits companies
are able to offer,” she says.
According to the survey, working moms
also find it tough to set aside time to take
care of themselves and their own health
with most spending less than an hour a day
on themselves. To ease mothers’ sense of
stress and emotional burden, Hudsonberg
encourages partners to get more involved
in the domestic sphere and take more
responsibility for family care where possible.
Of the moms who participated in the survey
most were in their twenties, thirties, and
forties, 93 % work full time, 29 % are single
parents and most have either one or two
children.
Working moms who are overwhelmed by
feelings of worthlessness, constant fatigue,
insomnia or suicidal thoughts should consult
their doctor or contact Pharma Dynamics’
toll-free helpline on 0800 205 026, which is
manned by trained counsellors who are on
call from 8am to 8pm, seven days a week.
WORKING MOMS’ MENTAL HEALTH KEY TRENDS

24. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
22
The NAPM was an endorsing
partner to the second
Manufacturing Indaba on
29th June, sponsored by the
Ekurhuleni Metropolitan Council,
to promote manufacturing
capabilities within the
Ekurhuleni jurisdiction.
Opening to the two-day
Annual Manufacturing Indaba
in Kempton Park, Davies said:
“Manufacturing is critical to
the South African economy
and it can be used to create
new sustainable growth
through the diversification of
our economy. This can lead to productive,
active and inclusive higher levels of advanced
manufacturing and industrialisation.”
The aim of the conference is
to boost the growth potential
of key manufacturing industry
sectors, and to provide a platform
for informative and interactive
sessions with the prime movers
of the nation’s manufacturing
sectors.
Davies added that one could not separate job
creation and industrialisation as they went
hand in hand and that South Africans and the
rest of the continent needed to move up the
value chain and diversify their economies.
“Real opportunities for the market lie in the
African market and we need to industrialise
as a continent. We have to
find ourselves a different niche
in a changing African market
through strategic cross-border
infrastructure upgrading,
complementary natural resource
development, integrated
industrialisation, reductions in
inter-state red tape and rapidly
expanding intra- and inter-
regional trade,” said Davies.
Davies further explained that
extraction and exporting played
a small part in the industry turn-
over and that if government
and the private sector worked closely with
and support local manufacturers export and
competitiveness could be raised.
Chairperson of the Manufacturing Circle,
Bruce Strong, said the manufacturing industry
enabled South Africa to create more jobs.
“The industry is important in that it employs
1.6 million people and contributes 12% to the
Gross Domestic Products. This has led to
many skilled people employed and sustained
in the long-term,” he said.
While he agreed that there was a
market access in Africa, Strong said the
manufacturing industry still needed to gear up
in order to be competitive.
Although there was no discussion on the
pharmaceutical industry per se, Stavros Nicolaou,
a senior executive of Aspen was chosen as a
moderator for one of the session.
Manufacturing Indaba to
encourages local production

25. 23
After being introduced to Parliament in
February 2014 by the Minister of Health Dr
Aaron Motsoaledi, Bill 6 was approved by
Parliament on 10th November 2015.
Bill 6 embraces an amendment to the
Medicines and Related Substances Act 101 of
1965, which allows for the Medicines Control
Council (MCC) to be replaced by the South
African Health Products Regulatory Authority
(SAHPRA).
Unlike the MCC which relies on operating
costs to be funded from the budget of the
National Department of Health SAHPRA
will be able to retain its own funds from
registration and licensing fees. This will
provide the opportunity for the authority to
recruit full-time evaluation staff outside the
parameters imposed by the Public Service
Commission. The Pharmaceutical Industry has
awaited this development since 2008 when a
Ministerial Task Team put forward a proposal
on the restructuring of Medicines Regulatory
Affairs and the Medicines Control Council .
This task team found that the backlog in the
registration of medicines from 2003 until
November 2007 was at 63% where 3731
applications had been received over that
period and only 1395 had been registered. It is
hoped that with improved resources, not only
the registration of drugs will be speeded up,
but important issues such as safety updates
and post registration amendments would
be approved within a shorter time frame,
improving access and safety for patients.
Once the President, Mr Jacob Zuma, signs the
Bill it will become law. It is therefore feasible
that SAHPRA could be in operation by early
2016.
SAPHRA becomes a reality
Registrar of the Medicines
Coontrol Council Dr Joey Gouws
being thanked by NAPM Chair,
Desmond Brothers, after her
presentation of the proposed
SAHPRA at the NAPM Annual
General Meeting.
KEY TRENDS

26. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
24
The MC Pharma Group offers specialist
medicine and health products regulatory
intelligence. We have been established
since 1996. Our aim is to support clients and
partners in every aspect of their market entry
into the South African and / or Sub-Saharan
pharmaceutical market. As a group, we
endeavour to find innovative solutions in an
ever changing international market to assist
our clients in reaching their goals.
We supply regulatory affairs support in the
following environments:-
• Pharmaceutical medicines including
biologicals
• OTC pharmaceuticals
• Surgical Implants
• Dermo/Cosmeceuticals
• Cosmetics
• Complementary medicines
• Medical devices / Diagnostic devices
We have a commercialisation division,
specifically established to assist Principals
who do not wish to open their own local
commercialisation office, but who still
wanted to be able to direct marketing
activities. Through this division we offer
sales representatives that service both
the pharmacy and specialised hospital
environment. Our newly established meeting
and training venue, is available. For further
information call us on 012 668 3019/21.
MC Pharma GroupMEMBER
PROFILE

27. 25
IGPA 2015
Sun Pharma began the integration of
Ranbaxy’s business following the successful
closure of its merger on March 25, 2015. The
integration, planned by Sun Pharma over
many months, focuses on supporting strong
growth. The historic merger fortified Sun
Pharma’s position as the world’s fifth largest
specialty generic pharmaceutical company
and the top ranking Indian Pharma company
with significant lead in market share. The
combined entity’s manufacturing footprint
covers 5 continents with products sold in
over 150 nations with a stronger presence in
US, India, Asia, Europe, South Africa, CIS
Russia and Latin America. Sun Pharma now
offers a large basket of specialty and generic
products encompassing a broad range of
chronic and acute prescription drugs as well
as a ready foray into the global consumer
healthcare market. The integrated culture
theme, “Growing Together”, represents
the core objective of this merger focusing
on improving productivity, compliance
commitment; focus on quality and sustainable
growth. Through this merger Sun Pharma
emerges as India’s first truly global
pharmaceutical company.
It is an important milestone in the history of
Sun Pharma as it enters into a new phase
of growth. The company will continue to
focus on gaining trust of the Regulators
globally while continuing to develop products
based on patient needs and leverage them
to become brand leaders globally. The
combined entity capitalizes on the
expanded global footprint and enhances its
dominance as a world leader in the specialty
generics landscape. Sun Pharma remains
committed to uncompromised product
quality, 100% compliance and promotes
innovation to create the most dynamic
global specialty generics pharmaceutical
company. The company believes that its
shareholders, customers and employees
share its excitement in the potential of this
combination.
This merger strengthens Sun Pharma’s
foundation with a strong multi-cultural
team of over 30,000 employees representing
over 50 global cultures making the combined
entity a truly global corporation in spirit
scale.
The combined entity comprises best
intellectual capital, capability of nearly 2000
scientists and the ability to invest significantly
in RD. The focus of RD investments
will be to harness multiple capabilities
and technologies for developing complex
products in addition to the combined entity’s
core business of offering affordable generic
medicines. The combined entity will continue
developing innovative and complex generics
that boast of technical differentiators.
SunpharmaMEMBER
PROFILE
INSIDE

28. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
26
Regional Pharmaceutical
Production
Mothobi Godfrey Keele, an NAPM member
was delegated by the Southern African
Generic Medicines Association (SAGMA) to
represent the association on the Technical
Review Committee which evaluated the report
of a consultant group investigating:
PHARMACEUTICAL PROJECTS FOR SADC
The Secretariat of Southern Africa
Development Community (SADC) is executing
three projects in line with its Protocol on
Health. The focus of the initiative is to achieve
three interrelated objectives, namely to
establish modalities for group contracting
(pooled procurement) of medicines
and health commodities; to undertake a
feasibility study to establish mechanisms for
regional production of medicines and health
commodities and lastly to establish regional
centres of excellence and specialization for
pharmaceuticals. Work in these three areas
has started and is at varying degrees of
completion.
Regional Production of
Pharmaceuticals and Health
Commodities
A project to consider the feasibility of
Regional Production of Pharmaceuticals
and Health Commodities was awarded to Hera
(a pharmaceutical systems consulting firm)
based in the Netherlands. At the meeting
, held in Gabarones in October 2015, the
Consulting firm presented its first draft report
seeking input from the Technical Review
Committee (TRC). The preliminary findings
are that the success of regional production
of pharmaceuticals is contingent upon the
following:
1. Policy reforms by the member states -
adoption of ‘pro-manufacturing’ policies,
implementation of the pharmaceutical
business plan of both the SADC the AU,
coherence between the policies of both the
trade and health ministries at both regional
and national level.
2. Incentives – an integrated incentives
package that is linked to the pharmaceutical
industrialization policy which includes,
interalia, low interests loans, low or no
taxes, national preferencial acquisition,
incubation programmes for startups
3. Regulatory compliance – embarking on a
roadmap to assist near GMP facilities, and
adoption of strict regulatory authorities
with clear legislation for pharmaceutical
inspections, and access to accredited (at
ISO level, ISO 17025) testing laboratories
4. Harmonization – development of the
same regulatory standards and processes
across the region, joint assessment of vital
essential medicines and fast tracking of
products already registered with the WHO
PQP
5. Leveraging of the TRIPS Flexibilities – the
current products that are under patent post
2005 when India became the signatory of
the WIPO provides a window of opportunity
in that India cannot get to the market ahead
of other countries. Furthermore, exploit the
flexibilities in terms of compulsory licensing
and technology transfers.
A

29. 27
IGPA 2015
Group contracting (pooled
procurement) of medicines
and health commodities
The SADC’s pharmaceutical
business plan identifies improving
the sustainable availability and access to
affordable, quality, safe, efficacious essential
medicines as one of its priority objectives.
To achieve this, SADC commissioned a study
to develop a strategy for implementing
a pooled procurement program in which
the purchasing processes usually handled
by each Member State could be jointly
executed. The assessment concludes that
pooled procurement offers potentially
significant benefits for SADC Member
States. Procurement systems across SADC
Member States are generally similar, but the
harmonization of standards, regulations, and
procedures are necessary to move the SADC
pooled procurement agenda. The report
was ratified by the TRC and is ready to be
tabled at the meeting of the ministers of the
member states.
Centers of Excellence and
Specialization for Plugging
the Training and Research
Needs in the Region
Weak regulatory systems, poor
regulatory capacity, limited research
and development capacity, inadequate
supervision of clinical trials, and shortage
of adequately and appropriately trained
pharmaceutical personnel were identified as
factors that could derail most of the SADC’s
initiatives for improving health. A study was
commissioned to assess the training and
research needs of pharmaceutical regulators
and managers in the SADC region to facilitate
the establishment of Centres of Specialization
(CoS) and Centres of Excellence (CoE) in the
region.
A total of eight thematic areas for the
Centres of Specialization (Pharmaceutical
manufacturing; Medicines Regulation and
Quality Assurance; Pharmacy Practice; Clinical
Trials Monitoring; Pharmaceutical training;
Patient Safety and Pharmacovigilance;
Pharmaceutical Management and;
Pharmaceutical Policy and Operations
Research) and two for the Centres of
Excellence (Clinical Trials Design; General
Research Skills with Special Preference
to Pharmaceutical and Health Systems
Research) have been identified and will
be prioritized due to the magnitude of the
identified gaps. The report was ratified by the
TRC and is ready to be tabled to the ministers
of the member states.
B
C
INSIDEREGIONAL PRODUCTION

30. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
28
EXCO DATES
The Exco meeting dates are as follows:
Meeting 1 3 February 2016
Meeting 2 10 March 2016
Meeting 3 29 June 2016 and AGM
Meeting 4 11 August 2016
Meeting 5 28 September 2016
Meeting 5 16 November 2016
Left to right- Herman Grobler, Desmond Brothers Muhammad Bodhania, Paul Anley, Vivian Frittelli, Anita Smal, Lenisha Maharaj
Left to Right- Graham Holt, Gaurav Jain, Erik Roos, Lorraine Keyser, Reshlan Nagoor, Melinda Badenhorst
Left to Right- Kingsley Tloubatla, Suhail Gani
NOTES
ON NAPM
The National Association
of Pharmaceutical
Manufacturers (NAPM)
represents the interests
of generic medicine
manufacturers and
marketers in South Africa.
The association’s mission
is to champion greater
access to medicine by the
South African population.
Vivian Frittelli, CEO of the NAPM was appointed Chairperson of the
International Generic and Biosimilar Association for the period ending 31st
December 2016. The IGBA was registered in Geneva Switzerland in October
2015 as an international not for profit association which members include
the generic medicines associations in the USA, Canada, European Union,
Japan, Taiwan, Jordan, Australia, Mexico, and Brazil. Applications are being
considered from some Asean, South American and Pacific Ocean Countries.

31. 29

32. To stay in touch with the NAPM office and keep yourself informed
of the latest developments and points of interest we invite you to
go to the NAPM’s website www.napm.co.za and get connected.
NAPM Member Companies
Abex Pharmaceutica
Accord Health
Actavis
Activo
Austell Laboratories
Bliss Pharmaceuticals
Cipla Medpro
DI Medicine Consultants
Dr Reddy’s
Execu Regulatory Services
MC Pharma Consultants
Medreich
Metanoia Pharma Consulting
Moteli Consultants
Mylan
MRA Regulatory Consultants
Pharma Dynamics
Prima Pharma Consultants
Sunpharma
Teva
Zydus
Contact Us:
Email: info@napm.co.za
Website: www.napm.co.za
Tel: 011 312 6966
Fax: 086 529 4245
LINKING OUR MEMBERS
TO INDUSTRY NEWS AND VIEWS