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  1. The pharmaceutical industry March 27th 2014, University of Zurich Fabienne Heimgartner, Interpharma

  2. Whatitneedsforonedrug CHF investment workinghours experiments scientists drug 1 000 000 000 7 000 874 6 587 423 1

  3. A longwaytogo… Quelle: Helsana

  4. Overview • Interpharma • Economicimpactofthepharmaceuticalindustry • Research & Development • Market access • - Counterfeiting • Medical progress – someexamples • Socialresponsibility • Main challenges for the pharmaceutical industry

  5. Interpharma • … is the association of research-based pharmaceutical companies in Switzerland • … was founded 1933 • … wants to create conditions conducive to innovation so as to promote pharmaceutical research, development and production • … supports efforts to create a social, economic and political environment that strengthens Switzerland as a center of pharmaceutical research and production • Member companies: Actelion, Novartis, Roche, AbbVie, Alcon, Amgen, Bayer, Biogen Idec, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Janssen, Merck Serono, Pfizer, Sanofi, UCB and Vifor

  6. World • EMEA EMEA EMEA EU IFPMA PhRMA Switzerland EFPIA Interpharma partners OECD Europe WHO EMA

  7. Economicimpactofthepharmaceuticalindustry

  8. Switzerland: most competitive economy in the world Source: World Economic Forum: The Global Competitiveness Index 2013–2014

  9. Worldwide market shares 2013 Source: Interpharma mit Datenbasis IMS Health Schweiz

  10. The pharmaceuticalindustrymatters… Pharmaceuticalindustry More than 169’800 employees • Direct: 39‘500 • Indirect: 130’300 • Multiplier: 4.3 32% of total Swiss exports • 64.1 Mia CHF (2012) Gross added value: 6.0% of GDP (35.5 Mia. CHF, 2012) • Direct: 3.3% • Indirect: 2.7% • Multiplier: 1.8 4x more productive compared to overall economy • (workplace productivity in 2012) • Employee pharma: CHF 488’000 • Employee overall economy: CHF 124’000 Source:The Importance of the Pharmaceutical Industry for Switzerland, study by Polynomics on behalf of Interpharma, October 2013.

  11. Whatthe Swiss sayaboutthepharmaceuticalindustry..

  12. Research & Development

  13. Worldwide R&D expenditures

  14. R& D Investments • Portion of R&D costs on sales Source: Booz & Co, The 2012 Global Innovation 1000 Study, 2013.

  15. Whichtherapeuticareasarestudied?

  16. Preclinicalandclincalstudies Activeingredientsaretestedforsafetyandefficacy Source: www.ipmglobal.org

  17. Global frameworkforclinicalresearch • Helsinki-Declaration (1964): importantethicalframework • informedconsentofprobands/patients • outweigh the risks and burdens to the research subjects • independentassessmentsby Research EthicsCommittees • „Good Clinical Practice“ GCP-Guidelines • scientificqualitystandardsforclinicaltrials • havetobeembodied in national laws • Biomedicine-Convention (1997) und additional protocols • Minimum standardstoprotect human rightanddignity in medicineandbiology • Recommendationsofthe Council of Europe • … • National Laws • Humanforschungsgesetz / Heilmittelgesetz

  18. Probability of success to market Source: CMR International 2012 Pharmaceutical R&D Factbook

  19. Bottlenecks: Reasons for failure

  20. Market access

  21. Drug approval /authorisation • Efficacy, safety, quality • Examinationofsubmitteddocuments (clinicaldata on efficacy, safety, quality, purity ..) • Check whether international guidelines have been followed (On-siteinspections) • After approval • continuoussurveillance • ofsafety

  22. Pricing and reimbursement • Swiss Federal Office for Public Health (BAG)  Relative efficacy, suitability, efficiency • Therapeutic comparison with comparable drugs on the market • International pricereferencing every three years • Country basket: Austria, Germany, Denmark, France, UK and the Netherlands • Federal Medicines Commission as an advisory committee to BAG includes experts and stakeholders  List ofpharmaceuticalspecialties (SL)

  23. International drugprices The cooperation between industry & government in Switzerland

  24. What is a fair price for a drug? „ I see more creative pricing models as we go forward, and these pricing models will always be specific to the individual countries because the needs, resources and healthcare delivery systems are very specific to those countries. We are prepared to go for not only differentiated pricing across countries, but also within countries. ..But for this kind of system to work, solidarity between rich and poor countries is needed..“ Severin Schwan, CEO Roche

  25. Globalisedprovisionofdrugs • Globalisedproductionanddistribution Safetyofdrug, safetyofsupply, safetyofdosage.. Falsifiedmedicines (Counterfeits) Illegal drugimports • Difficulties in deliverysupplybottlenecks Negative impacts Medicationmistakes

  26. Illegal drugimports in Switzerland on therise Stoppeddrugdelivieries(Source: Swissmedic) • 2008: 687 • 2010: 1861 • Swissmedicanticipatesover 50‘000 illegal deliverieseachyear Source: Pfizer

  27. Counterfeit medicines – Somefacts • Approximately 10% of all drugsarefalsifiedglobally- over 30% in some countries ofLatinAmerica, SoutheasternAsiaandAfrica (WHO,OECD ) • Multi-billionsalesforgloballyorganisedcriminals • Over 50 % of all drugs, illegalysoldfromtheinternet, arefalsified(WHO) • High healthrisk > 200‘000 annualdeaths(WHO)

  28. Fightagainstcounterfeiting MedicrimeConventionofthe Council of Europe • Safeguarding of public health through penal measures against criminal behaviors, protection of victims • promotion of cooperation at national and international levels StopPiracy (www.stop-piracy.ch) • Public education • Public sector: Swissmedic, IGE, seco, EDA, …economy: pharma, watches, software,food.. • Interpol • Public AwarenessCampaignagainstinternationallyorganisedcrime

  29. Medical progress – someexamples

  30. In 1994, 50x morepeopledied in Switzerlandthantoday Today: >30 HIV drugsavailable Medical progressesHIV/ AIDS

  31. 2011: firsttherapyfor MS in tablet form isapproved (escalation-therapy) 2013: European approvaloftwotabletsforthetreatmentofrelapsing-remitting MS  forthefirst time, thereis an oral MS-therapyavailable (rrMS) Medical progressesMultiple sclerosis

  32. Autoimmune disease 50-60% ofpatients do not respondtobroad-actingdrugs Todate, 5 biologicals (mostlyantibodies) are registered, moretofollow.. 2/3 ofsevere RA-patientsrespondvery well tobiologicals - fast andtargetedefficacy - fewadverseevents - preventionofjoint-destruction - reductionofmorningstiffness Medical progressesRheumatoid arthritis

  33. „novel“ revolutionarysubstanceclass Big, highlycomplexmolecules not easy tocopy ≠ generics (Biosimilars) Insulins, antibodies, proteinstostimulatebloodcells Totreat MS, cancer, diabetes… Biologicals = Biopharmaceuticals . Producedwithbiotechnicalprocesses in livingcells (e.g. hamster cells, bacteria)

  34. Bio- andgeneticallyengineeredproducts Cancer Rheuma Multiple sclerosis Eye complaints Diabetes Hematopoiesis Vaccines Growth hormones others

  35. Benefitofdrugs: 40-percent accountabilityforincreasedlifeexpectancy Due tonoveldrugs Total

  36. Socialresponsibility

  37. The pharmaceuticalindustrysupports… Access programs: donations, education & training, pricing schemes, transfer of technology, capacity building Numerous multinational initiatives: e.g. Global Fund, GAVI, WHO, UNITAID Company programs: e.g. African Comprehensive HIV/AIDS Partnership (ACHAP) in Botswana (Merck); AmpliCarefordiagnosisandtherapyof HIV-positive mothersandtheirnewborns (Roche) Good governance: good manufacturing practices, ethical standards, guarantee high quality, safety & efficacy of medicines and vaccines, comply with regulatory requirements Socialresponsibility

  38. Collaborative programmeofvarious private andpublic partnersagainstneglectedtropicaldiseases (NTDs) Goal Eradicationof 5 NTDs andcontrolover 10 NTDs by 2020 Approach Sustain, expand and extend drug access programmes Advance R&D through partnerships and provision of funding Enable adequate funding with endemic countries to implement NTD programmes Examples Novartis : long-term commitment to leprosy treatment and control by donating multidrug therapy (Rifampicin, Clofazimin & Dapson) Pfizer : donationsofAzithromycinfortrachomauntilat least 2020 London Declaration 2020

  39. Projects againstdiseases in developing countries Source: IPFMA, Status Report, R&D for “Diseases of the Developing World (DDW)”, 2011 Quelle: IFPMA Facts and Figures. Issue 2012.

  40. Partnership-Directory http://partnerships.ifpma.org/pages/

  41. Governments in low/middleincome countries tosupportthedevelopment tocreateconduciveframeconditionsfor global partnercompanies High-income countries tofinanciallysupporthealthcare-systems in developing countries to promote vaccineprogrammes Challenges Donationsofdrugsareofnouse, wheninfrastructureismissing Sanitaryconditionspreventcertaintherapies (clean water..) Corruption, politicalinstability Missingengagementofgovernments in thefightagainstdiseases: lack/gapofinformation The industryappealsas well to.. Source: Technology Transfer: a Collaborative Approach to Improve Global Health, IFPMA ,2011.

  42. Main challengesforthepharmaceuticalindustry

  43. Changes in healthcare systems Aging world population demand for medical care is growing, which is forcing the funding organizations to take aggressive cost-containment measures. Unhealthy lifestyles increasein chronic diseases. Emerging markets allowingthe populations of these countries greater access to healthcare services. Advances in science and technology innovative medicines, but also increase in innovationcosts.

  44. Causesofdeathnowandthen • 1980: 2011: Cardiovascularsystem Tumors Psyche Respiratorysystem Nervoussystem Accidentsandviolence Digestive system Metabolismandblood Suicide Infections Others Cardiovascularsystem Tumors Respiratorysystem Accidentsandviolence Digestive system Metabolismandblood Suicide Nervoussystem Infections Psyche Others

  45. Demographicchange Source: WHO, 2005

  46. Thereare still notherapiesfor 2/3 of all diseases Agingpopulation morechronicdiseases Cancer mostprobablythemostcommonfuturecauseofdeath Challenge dementia triplicationofdiagnosesuntil 2050 Great demandforresearchpersists

  47. What drives innovation? • Medical need • Scientific advances • Market incentives • Innovation-friendly regulatory, economic and IPR framework • Stable and predictable environment Scientific Advances Medical Need

  48. Other challenges for the industry • Policy makers becoming increasingly concerned about health expenditure and cost of innovation • Debate too much focused on cost and not on efficiency • Growing concern over possible ineffective (or harmful) use of untested technology • Need for enlightened tools for assessing value of health care services

  49. Thankyouforyourattention! fabienne.heimgartner@interpharma.ch phone: 061 264 34 44