1
IGPA 2015
LINKING OUR MEMBERS
TO INDUSTRY NEWS AND VIEWS
NOVEMBER 2015
NAPM
REVIEW
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
2
1
IGPA 2015
2 IGBA 2015- special report
10 New findings on generics usage in SA indicate
significant savings on drugs expe...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
2
On September 16-18, 2015 the International
Generic Pharmaceutical Allianc...
3
IGPA 2015
down. Hoskins said that he is working with
the other Canadian provinces to increase use
of generic medicines, ...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
4
50 days ago, and FDA’s vision that quality
metrics can predict disruptive...
5
IGPA 2015
pleasure and pain. Hussain described the
“nocebo” effect, where the mere suggestion
that a patient may experie...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
6
Senior Counsel, McGuireWoods provided an
overview of approval mechanisms,...
7
IGPA 2015
the generic industry has gotten to the
trade negotiations table late, resulting in
imbalances in patent linkag...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
8
proposal, which FDA believed would prevent
inadvertent substitution and f...
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IGPA 2015
Picture of the participants
in the presentation of Trade
Principles at the IGBA
meeting in Toronto.
L to R Viv...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
10
A study conducted recently on behalf of
the National Association of Phar...
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GENERIC USAGE IN SA
“These savings would enable medical
schemes to offer improved benefits or
to curb increases in prem...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
12
The United Nations Industrial Development
Organization was the main spon...
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IGPA 2015
the pharmaceutical industry. It is important
that the government departments show
coherence in their strategi...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
14
Addressing a session called “Principles
to Foster Trade in Generic and B...
15
IGPA 2015
pro-competitive provisions to prevent IPR
abuse/misuse, and;
• Establishing an appropriate framework
for ince...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
16
According to Keon, regulatory
convergence is desirable for
generic compa...
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IGPA 2015
He also said the TPP could put at
risk the future and sustainability
of global generic and biosimilar
industr...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
18
The draft policy on Intellectual Policy (IP) in
South Africa issued in J...
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IGPA 2015
of Health Dr Aaron Motsoaledi described
the alleged campaign as a” satanic plot” and
“genocide “. Consequentl...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
20
Study shows
working moms’
mental health
deteriorating
The demands of kee...
21
IGPA 2015
accommodating. With the impossible
schedules modern mothers manage,
something inevitably has to give and the
...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
22
The NAPM was an endorsing
partner to the second
Manufacturing Indaba on
...
23
After being introduced to Parliament in
February 2014 by the Minister of Health Dr
Aaron Motsoaledi, Bill 6 was approve...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
24
The MC Pharma Group offers specialist
medicine and health products regul...
25
IGPA 2015
Sun Pharma began the integration of
Ranbaxy’s business following the successful
closure of its merger on Marc...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
26
Regional Pharmaceutical
Production
Mothobi Godfrey Keele, an NAPM member...
27
IGPA 2015
Group contracting (pooled
procurement) of medicines
and health commodities
The SADC’s pharmaceutical
business...
LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS
28
EXCO DATES
The Exco meeting dates are as follows:
Meeting 1 3 February 2...
29
To stay in touch with the NAPM office and keep yourself informed
of the latest developments and points of interest we invi...
NAPM Review Dec 2015
of 33

NAPM Review Dec 2015

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.
Published on: Mar 3, 2016
Published in: Health & Medicine      
Source: www.slideshare.net


Transcripts - NAPM Review Dec 2015

  • 1. 1 IGPA 2015 LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS NOVEMBER 2015 NAPM REVIEW
  • 2. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS 2
  • 3. 1 IGPA 2015 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
  • 4. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS 2 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
  • 5. 3 IGPA 2015 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. BIOSIMILARS Q UA LITY Harm onization IGPA 2015 SPECIAL REPORT
  • 6. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS 4 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 irrational humans are when it comes to
  • 7. 5 IGPA 2015 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, BIOSIMILARS Q UA LITY Harm onization IGPA 2015 SPECIAL REPORT 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.
  • 8. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS 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.
  • 9. 7 IGPA 2015 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 BIOSIMILARS Q UA LITY Harm onization IGPA 2015 SPECIAL REPORT
  • 10. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS 8 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. BIOSIMILARS Q UA LITY Harm onization IGPA 2015
  • 11. 9 IGPA 2015 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 10 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
  • 14. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS 12 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 Skills Gap
  • 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
  • 16. LINKING OUR MEMBERS TO INDUSTRY NEWS AND VIEWS 14 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 stance on Trade Principles
  • 17. 15 IGPA 2015 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.
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  • 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

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