1
inside
Linking our members
to industry news and views
NAPM
Review
Linking our members to industry news and views
KEY
TRENDS
SPECIAL
REPORT
INSIDE
1 Challenging perceptions
4 From the Cha...
1
KEY
TRENDS
Challenging perceptions
A recent editorial in the Journal of Pharmaceutical Policy and Practice (JOPPP) advoc...
Linking our members to industry news and views
2
1. Prescriber Attitudes
Informal research has shown that physicians feel ...
3
Even locally manufactured generic medicines have at least a 60% imported content, which
makes the industry very suscepti...
Linking our members to industry news and views
4
From the Chairman’s Desk
Generic Trends
This last year has seen the gener...
5
KEY
TRENDS
Bio-similars: the Next Frontier
In November 2013 the Medicines Control Council issued guidelines for comment ...
Linking our members to industry news and views
6
Private healthcare
under the spotlight
The five person committee of the C...
7
SPECIAL
REPORT
Intellectual property on the
State’s agenda
The NAPM supported the draft intellectual property policy doc...
Linking our members to industry news and views
8
Fair pricing vs prescribed formulas
The most active committee in the NAPM...
9
SPECIAL
REPORT
The NAPM met with the Minister of Health Dr Aaron Motsoaledi at his office in Pretoria, to
discuss the fu...
Linking our members to industry news and views
10
The napm committee update
The new Executive Committee of the NAPM will b...
11
INSIDE
International connections
The NAPM is a member of the management committee of the International Generic
Pharmace...
Linking our members to industry news and views
12
Important dates
11 June NAPM Annual General Meeting
28 June Deadli...
13
INSIDE
Napm serving our members in 2014
Key Areas where the NAPM is making
a difference:
STAKEHOLDER
ENGAGEMENT
WORKSHO...
Linking our members to industry news and views
14
To stay in touch with the NAPM office and keep yourself informed
of the ...
of 16

Napm 2014 review

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


Transcripts - Napm 2014 review

  • 1. 1 inside Linking our members to industry news and views NAPM Review
  • 2. Linking our members to industry news and views KEY TRENDS SPECIAL REPORT INSIDE 1 Challenging perceptions 4 From the Chairman’s Desk, Generic Trends 5 Bio-similars: the Next Frontier 6 Private healthcare under the spotlight 7 Intellectual property on the state’s agenda 8 Fair pricing vs prescribed formulas 10 The napm committee update 10 Making our mark 11 International connections 13 Important dates 12 Napm serving our members in 2014 Key Areas where the NAPM is making a difference Our Vision To champion affordable and accessible healthcare, by promoting generic medicines and supporting the development of the South African pharmaceutical industry as a national asset. Our Mission To ensure that the healthcare sector plays a constructive role in our country’s economic growth, through development and transformation, thereby creating an environment that can thrive , expand, and be competitive , with the ultimate aim to enhance access of medicines to all of our country’s citizens. Objectives • To promote the use of generics medicines • To be the voice of the generic pharmaceutical industry in South Africa • To respond to regulations and represent members with government agencies • To provide information and facilitate trade opportunities for members CONTENTS
  • 3. 1 KEY TRENDS Challenging perceptions A recent editorial in the Journal of Pharmaceutical Policy and Practice (JOPPP) advocated research into the access of affordable of medicines. The article describes some of the barriers that generic medicine manufacturers face in gaining greater usage of their products. One of the arguments put forward are that funders do not actively promote the use of generic medicines. This is not valid in the South African context as the medical aid administrators in this country give great support to the dispensing of generic medicines through their reimbursement policies and formularies. Another barrier JOPPP discusses is the non-alignment of the medicines value change where incentives for distribution, wholesaling, prescribing and dispensing can be contradictory. In a presentation by the NAPM CEO at the conference on Market Access and Pricing held in April 2014 the challenges facing generic medicine suppliers in South Africa was the topic. Some of the barriers identified by JOPPP are relevant, but the others are pertinent only to our local market. Some of those discussed were: In our communication to the media and public the Association tries to emphasize that generic medicines are subject to the same registration and manufacturing regulations as the originators.
  • 4. Linking our members to industry news and views 2 1. Prescriber Attitudes Informal research has shown that physicians feel that funders impinge on their decisions when formularies defined by Pharmaceutical Benefit Managers (PBM) are imposed on them. Specialists especially feel that they have little or no say in how the formularies are compiled and in most cases consideration for the particular drugs are based on price alone. Consequently there is an aversion to prescribing generic medicines which comprise the major portion of the formularies. 2. Consumer Perceptions With regard to medicines, patients rely on their doctors in forming attitudes about generic medicines. If the physician is not averse there is general acceptance by the consumer. However it is a known consumer perception in marketing circles that the average person equates quality to price. It is hard for a patient to believe that a medicine costing a third of the price of an originator could have the same quality and efficacy as the higher priced medicine. 3. Intellectual Property The NAPM is in agreement with JOPPP in highlighting the challenges provided by intellectual property legislation. The concept of “ever greening” where for trivial changes to the manufacturing processes, patent periods are extended. In the majority of cases there is no extra benefit to patients as the finished product remains unchanged. The NAPM has supported the SA government in its publication of the draft IP policy to ensure patients are only granted for novel inventions through an examinations office. 4. Regulatory Delays An element which affects every one of the NAPM members. The lengthy registration times for generic medicines affect the patients, businesses, and industry. Our members alone have a backlog of more than 1000 dossiers to be evaluated. The members report that on average it is taking about four years to achieve a registration, but because of the long lead times, manufacturing processes have changed and post registration changes can take a further eighteen months. 5. Pricing Factors Input costs are of concern to any business, but in the generics industry the room to manoeuvre is limited. The regulations’ pertaining to medicines preclude the easy change of suppliers for active ingredients. This prevents shopping around for cheaper alternatives in the short term.
  • 5. 3 Even locally manufactured generic medicines have at least a 60% imported content, which makes the industry very susceptible to volatility in foreign exchange rates. The dramatic changes in the value of the Rand against the currencies of our trading partners since November last year create a hardship for generic suppliers due to the slim gross profit margins. Medical Aid driven formularies force generic marketers to be “price takers”. If a medicine is priced higher than the reimbursement level set by the medical aid administrator, the consumer would have to make a contribution towards the purchase price. Medical aid members in general are averse to paying a co-payment on a generic medicine. With the expansion of pharmacy chain stores the concept of formulary tendering has crept in. The generic medicine space is very competitive and choice is wide. This gives the pharmacy buyers the opportunity to stock those generic medicines which provide the greatest financial benefits in the form of advertising and the controversial “data fees”. Most telling of all in this debate is that many consumers are quite continent to pay over R200 for an unregistered, untested complementary or so called “natural “medicine, rather than R50 for a proven generic anti- inflammatory medicine. KEY TRENDS
  • 6. Linking our members to industry news and views 4 From the Chairman’s Desk Generic Trends This last year has seen the generic market continue to grow at double digits, recording a year end growth rate (MAT) of 10.3% with a unit growth of 4.2%. This implies that most generic companies took advantage of the price increase granted by the DoH and also reflects the growth of newly launched, off patent generics. The ethical market on the other hand recorded a much slower growth rate of 2.3% (MAT), the bulk of which was due to volume growth (2.1%). The market share of generics (MAT) has grown to 35.7% while the volume market share is now as high as 63%. There has been much debate recently about the pricing of generics relative to that of the originators, with some role players suggesting that the discount of generics could be greater than it currently achieves. The March IMS data suggests an average price for the ethical market of R5.28 per counting unit while the average price of generics is just R1.49, a 67% difference. While these figures are not comparing equivalent molecules, it does demonstrate the role that generics play in expanding access to medication.
  • 7. 5 KEY TRENDS Bio-similars: the Next Frontier In November 2013 the Medicines Control Council issued guidelines for comment on the registration of bio-similar medicines. A bio-similar medicine is a follow on biological medicine product whose active substance is made by or derived from a living organism by means of recombinant DNA or controlled gene expression. The term bio-similar was created by marketers to describe a subsequent version of innovator biopharmaceutical products developed following patent expiry. Generally, the difference between a small molecule generic medicine and a “follow-on biologic” is the complexity of manufacture and the imitator manufacturer does not have access to the originator’s cell bank. With substantial assistance from our member, Cipla, the NAPM submitted comments on 31st January 2014 broaching three main aspects which we believe are pertinent to the South African market. Firstly, given that safety, efficacy and quality should be the prime considerations in the registration of all medicines, guidelines for bio-similars need to be formulated in such a way as to abide by these tenets but also promote access to these advanced medicines by the greater population. Promoting access involves providing biological drugs at substantially lower prices than the originators’ versions. Access can either be promoted or prevented through the registration process. The proposed guidelines require local clinical trials to be conducted in each indication claimed by a bio-similar. In our submission we made a case for the utilization of clinical trials carried out in other regulated jurisdiction as evidence for registration of the indications. In addition to this some form of extrapolation of indication should be permitted. Included in our submission was a request for a right by healthcare practitioners to substitute originator medicines with a bio-similar as is allowed for generic medicines.
  • 8. Linking our members to industry news and views 6 Private healthcare under the spotlight The five person committee of the Competition Commission delving into the private healthcare market is led by former Chief Justice Sandile Ngcobo, was supposed to have started deliberations in February this year. This has seemingly been delayed by a court application from Netcare Hospital Group to oblige the consulting company, KPMG, to return all documents they hold pertaining to Netcare Hospital Group. KPMG, has acted as an advisor to Netcare in the past and allegedly hold 30 000 documents pertaining to Netcare in their IT system. The reason for Netcare’s application is that KPMG has been appointed as a support for the Competition Commission Committee probe into the Private Healthcare Market. The matter was set down for hearing in the High Court on 21st and 22nd May. The outcome of the application is still awaited at time of printing. The enquiry into the private healthcare market was announced on 13th May 2013 by the then Minister of Economic Development Mr Ebrahim Patel. The enquiry was the first to be undertaken after the amendment to the Competition Commission Act came into effect on 1st April 2013. Unlike the market enquiry into the banking sector where the participants cooperated on a voluntary basis, participation into this one is no longer voluntary. The committee has wide ranging powers such as to summons persons to appear and to provide documents. The Commission now also has the power to initiate a complaint against a firm based on information obtained in the inquiry. Under the Amendment Act, the commission is able to apply criminal sanction to the results of a complaint. The original terms of reference of the committee excluded the pharmaceutical sector from the inquiry. This is the only part of the healthcare sector subject to price controls. Despite this the CEO’s of both Mediclinic and Netcare called for the pharmaceutical sector to be included into the probe. The Minister acceded. Subsequent to this decision the then Deputy Commissioner of the CC, Trudi Makhaya with a panel, interviewed the CEO of the NAPM as a preliminary investigation. Ms Makhaya has since resigned from the CC. As the Association we can expect further contact when the inquiry committee starts their probe.
  • 9. 7 SPECIAL REPORT Intellectual property on the State’s agenda The NAPM supported the draft intellectual property policy document which was issued earlier this year. The publishing of the policy precipitated a row between the originator Association, IPASA, and the Minister of Health Dr Aaron Motsoaledi. The NAPM cooperated with the civil society organizations, MSF, Section 27 and TAC in formulating our response which is summarised below. 1. Patent terms relating to medicine should be limited to a maximum of 20 years as authorised by Article 33 of the TRIPPS agreement 2. The policy should clarify subject matter that is not considered patentable. (E.G. New uses, treatment of diseases, known processes applied to new pharmaceutical entities.) 3. The policy should define what is meant by novelty and inventiveness and require significant technical advances from the state of the art relating to pharmaceuticals. 4. The NAPM supports the draft policy in Chapter 1a) i) for the establishment of a substantive Search and Examination facility. 5. We support Chapter1 a) v) for the establishment of a Pre- and Post- grant opposition mechanism utilizing digital media and time lines for opposition. We further recommend that post grant to existing patents be allowed with a cut-off date in the region of the past 10 years. If this process was overseen by a competent authority the need to up skill Judges on patent aspects would be reduced. 6. We insist that although data ( such as clinical test data) be protected from commercial abuse, the data submitted to a government agency such as the MCC or its successor, may be utilised by that agency to evaluate generic medicines, for the benefit of the South African nation. Chapter 1a) vii) 7. Under the heading Disclosure of information in patents, we concur that sufficient information be disclosed in the lodging of a patent that would enable a technical evaluation of the patent. 8. The NAPM recommends that legislation under the jurisdiction of other government departments be brought into line to take advantage of TRIPPS flexibilities. E.g. regulations from the DOH impede parallel importation. 9. The patent act should supersede any bilateral or multilateral agreement between countries and these agreements should not be allowed to alter any provisions of the Act or its regulations 10. Patents granted in other jurisdictions should not become a prima facie basis for granting patents in South Africa. 11. We support the Bolar provisions allowing development of generic versions prior to the expiry of the originators patent. 12. We concur with the recommendations in Chapter 2 to simplify compulsory licensing.
  • 10. Linking our members to industry news and views 8 Fair pricing vs prescribed formulas The most active committee in the NAPM has been the pricing sub-committee. Headed by Graham Holt of Pharma Dynamics, the committee has dealt with various pricing regulations in the past year with much of the effort surrounding the annual price adjustment. The guidelines for the 2014 price adjustment were issued in September 2013. After evaluation the sub-committee, using the NDOH price adjustment formula, calculated that the price increase on the SEP should be at least 8,7%. In fact if there was an equal split between the consumer price index and the producer price index, the increase would be 9%. The NAPM submitted the information on the 11th November 2013, giving what we believe were justifications for the calculations based on the published formula; the high component of medicines that are imported; the cross subsidization of state tender products by the private market and the fact that an average forex rates based on the previous year has no relevance to the current rates at which medicines are procured. Alas, in February 2014, the industry was granted a 5,82% increase with effect from 1st April. This amount was the consumer price index, which has little bearing on the input costs of medicine. After submitting a letter to the NDOH expressing dismay at the price adjustment rate, considering the steep and dramatic deterioration of the Rand /Dollar and Rand/ Euro exchange rates. Following the letter, the Exco of the NAPM met with the Deputy Director General of the NDOH, Dr Anban Pillay. At the meeting Dr Pillay indicated that the Department would call for recommendations on how the formula should be derived. He further said that they were intending to have three levels of adjustment relating to originator products, imported generic medicines and locally produced medicines, respectively. We indicated to Dr Pillay that there was an immediate problem with the pricing and he made the offer that our member companies could approach his Department directly to seek relief on individual products. When the “change in formula” documents were released the NAPM consulted with its members. After evaluation the consensus was that the current formula was adequate, but it needed further engagement. If the formula had been used and not overridden by ”political” expediency, the industry would have gained about 5% over the past two years which would have helped to stabilise the exchange rate volatility. After all according to the Council for Medical Schemes, the rate of increase in medicines was in single digits as opposed to that of Specialists, Private Hospitals and Medical Aid Administrators.
  • 11. 9 SPECIAL REPORT The NAPM met with the Minister of Health Dr Aaron Motsoaledi at his office in Pretoria, to discuss the future of the generic medicine industry in South Africa. At the time the Intellectual Property Policy was a discussion item, Dr Motsoaledi indicated that the government would double the treatment of HIV/Aids patients within the next couple of years and also provide intensive treatment for tuberculosis. Access could only be achieved through the promotion of generic medicines. IN ATTENDANCE from Left to Right: Dr Anban Pillay Deputy Director General (DOH). Tommy Scott (Pharma Dynamics) Gaurav Jain (Zydus), Herman Grobler (Cipla), Vivian Frittelli (NAPM), Dr Skhumbuzo Ngozwana (independent Consultant) Dr Aaron Motsoaledi, Minister of Health, Nihar Patnaik (Dr Reddys), Muhamad Bodhania (Medreich), Anita Smal (Abex). Generic medicines are subject to price dampening through the competitive nature of the market, so any price adjustment allows a breathing space for medicines with exceptional increases in input costs. The NAPM submitted its recommendations before the deadline on 28th March 2014 and requested that the exchange rate utilised should be based on the current situation. We heard afterwards that Pharmisa and IPASA have requested an extension, which was granted for another three months. The NAPM, having left membership of the Pricing Task group (PTG) some three years previously was invited to attend a meeting with the group and Dr Pillay. This meeting, to discuss the formula, was cancelled a few hours prior to the start. Cynically, we believe this was cancelled to allow publication of the International Benchmarking Regulations, for comment. The IBR may negate the concept of an annual price increase as a cursory look at them indicates that the prices in the benchmark basket countries should be evaluated annually. The impression had been created in the past that the IB would be a once off process. The NAPM pricing committee is meeting early in May to evaluate the impact the regulations will have on generic medicines.
  • 12. Linking our members to industry news and views 10 The napm committee update The new Executive Committee of the NAPM will be elected at the 37th Annual General Meeting on 11th June 2014.05.29 We thank the outgoing Committee for their contributions during the past year. This work was on a voluntary basis to benefit all members. During the year Kevin Grant was replaced by Herman Grobler, COO of Cipla and Skhumbuza Ngozwana (Consultant), Suhail Gani CEO of Austell and Kingsley Tloubatla CEO of the Bliss Group were co-opted onto the committee. The good news is that all have agreed to nomination on the 2014/2015 committee. Making our mark We are pleased and proud to report that Ms Anita Smal, a member of the NAPM Exco, was nominated and elected as secretary with the ITG which is representative of the industry in meetings with the Registrar and management of the MCC. Anita, who has performed the function before is very efficient in providing and supplying minutes of the meetings and disseminating valuable information concerning the regulatory body. In addition Anita heads our scientific committee and single-handedly has been responsible for countless submissions on technical guidelines from the MCC and NDOH. We thank Anita for her valuable contribution to the NAPM. From Left to Right: Vivian Frittelli, CEO, Gaurav Jain, Muhammad Bodhania, Vice Chair, Desmond Brothers, Kevin Grant, Paul Anley, Chair, and Anita Smal.
  • 13. 11 INSIDE International connections The NAPM is a member of the management committee of the International Generic Pharmaceutical Alliance (IGPA). Co members on the committee are the US Generic Association (GPhA), the Canadian Generics Association (CGPA), the European Generics Association (EGA), the Jordanian Association of Pharmaceutical Manufacturers (JAPM) and the Japanese Generic Association (JGA). The IGPA is in its 17th year of existence. The benefits of belonging to the International alliance enable us to share information on intellectual property, trade and scientific aspects affecting the generic medicine and biopharmaceutical medicine industries. The IGPA has three subcommittees to which members of the various Associations belong. There is opportunity for members of the NAPM companies to serve on these sub-committees. These sub-committees are coordinated by members of the management committees. Senior members from our own members’ head offices participate such as Teva and Mylan. The sub- committees comprise Scientific, Trade, and Intellectual Property. A fourth committee under the lead of Suzette Kok of the EGA is being established to cover Bio-similars. The IGPA with its committees develops and provides position papers on aspects such as benchmark pricing; Generic Medicines in Trade agreements and in relation to TRIPS and Patent Protection. The IGPA holds an annual meeting with the WHO, WIPO and WTO in Geneva. This year the meetings are on 10th and 11th June and conflict with our AGM. The members of the IGPA are able to gain information on the future policies and strategies from these UN committees as well as provide input from a generic medicine point of view. In the past the IGPA relationships were governed by a formal agreement to which each member complied. Mechanisms are in motion to register the IGPA as an association in Switzerland as a legal enterprise. This will afford official recognition by the committees of the United Nations. The IGPA is currently lobbying for a place on the International Committee for Harmonization (ICH), The IGPA holds an annual conference to highlight issues pertaining to generic and bio-similar medicines around the world. The 2011 conference was hosted in South Africa. In 2014 the conference is being hosted from 19th to 21st November by the US Generic Association in Key Biscayne, Miami, Florida. Details can be found at www.Gphaonline.org/events/upcoming- events/17th-annual-igpa-conference 19 – 21 Nov Key Biscayne
  • 14. Linking our members to industry news and views 12 Important dates 11 June NAPM Annual General Meeting 28 June Deadline for comments into alternate formulae for SEP adjustments 12 August Deadline for comments on International Benchmarking 28 August Deadline for comments on Foodstuff labelling 19-21 November International Generic Pharmaceutical Alliance (IGPA) annual conference, Miami.
  • 15. 13 INSIDE Napm serving our members in 2014 Key Areas where the NAPM is making a difference: STAKEHOLDER ENGAGEMENT WORKSHOPS ADVOCACY LOBBYING POLICY ADVICE INTERNATIONAL REACH HEAD OFFICE Interviews and comment in trade publications/ radio/ television Issue of press releases to media Invited and participated in 7 government workshops Evaluation, distribution and or comment on 27 regulations issued by Departments of Health and Trade and Industry. Including submissions on pricing, Intellectual Property and Bio-similars Participation in SAGMA meet- ings Refurbishment and input into NAPM website Presentations at various health conferences CPD for doctors on ethics and generic medi- cines Represent NAPM at Reg- ulatory Discus- sion Group on CAMs Executive mem- bership of IGPA Conversion of NAPM Articles of Association to Memorandum of Incorporation Presentation and motiva- tion to UNIDO on project for eCTD skills training Workshop on new BBEEE legislation Participation in the MCA pro- cesses Participation in IGPA Trade and Intellectual Property sub- committee Participation in student re- search projects Workshop on sales models Participation in Industry Task Group (ITG) with the MCC Workshop on CAMs legisla- tion
  • 16. Linking our members to industry news and views 14 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 Pharmaceuticals (Pty) Ltd Activo Health (Pty) Ltd Aurobindo Pharma SA (Pty) Ltd Austell Laboratories (Pty) Ltd Bliss Pharmaceuticals Cipla Medpro DI Medicine Reg. Consultants (Pty) Ltd Dr. Reddy’s Laboratories (Pty) Execu Regulatory Services Mc Pharma (Pty) Ltd Medreich (Pty) Ltd Mylan Ltd Mra-Regulatory Pty) Ltd Pharma Dynamics (Pty) Ltd Primapharma (Pty) Ltd Ranbaxy SA (Pty) Ltd Teva Pharmaceuticals (Pty) Ltd Watson Pharma (Pty) Ltd Zydus (Pty) Ltd 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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