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South-East Asia Bangladesh Home Health topics Our work News Emergencies About us Home / News / Detail / Bangladesh steps up efforts to control quality of medical products Bangladesh steps up efforts to control quality of medical products 3 March 2019 Highlights In February 2019, WHO organized a peer audit of Bangladesh National Drug Control Laboratory (NCL) which is an important step for the laboratory to achieve WHO prequalification status, an international recognition of complying with WHO’s recommended standards. (...) In the same efforts of strengthening control quality of medical products, Bangladesh is hosting in March 2019 a regional workshop for the Asia Chapter of the Network of Official Medicines Control Laboratories (NOMCoL). (...) Other SDG targets are also related with access to medicines thus emphasizing the critical role played by national control laboratories for medicinal products. WHO will continue supporting Bangladesh to strengthen the regulatory system for medical products, as an essential pillar of a solid health system. 
Language:English
Score: 810844.4 - https://www.who.int/bangladesh...ol-quality-of-medical-products
Data Source: un
But what about the waste and by-products that arise from these activities? The question is very serious. (...) In 2019, the Government of the country issued a decree No. 719 "On the management of medical waste and mercury-containing products in health care organizations of the Kyrgyz Republic." (...) The adverse health effects associated with waste and by-products are numerous. This is the risk of infection and injury caused by sharp-piercing objects; toxic effects of pharmaceutical products, in particular antibiotics and cytotoxic drugs released into the environment, and substances such as mercury or dioxins, during medical waste handling or incineration; chemical burns during disinfection, sterilization or waste treatment; poisoning and pollution of the environment with toxic elements or components formed during combustion; thermal injuries due to open burning and the operation of medical waste incinerators; radiation burns.
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Score: 809545.2 - https://www.undp.org/kyrgyzsta...-%E2%80%93-healthy-environment
Data Source: un
Has it helped? Local production of medical technologies and devices can help reduce barriers to use and maintenance. One study notes that more than half of the medical equipment in developing countries is not maintained or functioning properly, and local production and technical support for medicines and devices is being encouraged to address this problem.2 Local production of pharmaceuticals can decrease transport costs, encourage use of local raw materials, provide local jobs, increase local expertise, and cut dependence on foreign suppliers. The Food and Nutrition Technical Assistance program has successfully supported the treatment and prevention of malnutrition through locally produced supplements in Malawi, Haiti and Kenya and other countries.3 The government of Ghana's drug policy seeks to level the playing field between international and national manufacturers to increase competition and reduce price of medicines.4 There are, however, questions raised about the efficiency of local production, as it could reduce economies of scale compared to global production and may make quality control to international standards more difficult.5,6 Ongoing research is required to optimize the development and deployment of local solutions to improve maternal, newborn and child health. 1 Howie S et al (2008) Beyond good intentions: lessons on equipment donation from an African hospital, Bull World Health Organ vol.86 no.1 Jan. 2008 2 WHO (2010)Barriers to innovation in the field of medical devices - Background paper 6: Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project.
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Score: 809418.9 - https://www.who.int/pmnch/abou...m/2010_showcase/en/index8.html
Data Source: un
Select language Select language English South-East Asia India Home Health topics Our work News Emergencies About us Home / News / Detail / 2nd World Conference on Access to Medical Products 11 October 2018 - Achieving the SDGs 2030 2nd World Conference on Access to Medical Products 11 October 2018 - Achieving the SDGs 2030 18 October 2018 Highlights Day 3 update - 11 October 2018 The summary and recommendations of the three-day proceedings were presented at the concluding session of the `2nd World Conference on Access to Medical Products: Achieving the SDGs 2030 agenda’. The recommendations were listed and categorised into the following broad areas: Access to Medical Products, including vaccines, drugs, diagnostics, and equipment; Research and Development; Capacity-building; Training; Regulatory and Market Access; and Intellectual Property (IP). (...) “We must innovate and focus on areas such as indigenous product development (to substitute imports), antimicrobial resistance (AMR) and manufacturing of medical equipment.
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Score: 808891.26 - https://www.who.int/india/news...2018---achieving-the-sdgs-2030
Data Source: un
Medical Product Alert N° 1/2019: Falsified Rabies Vaccines Global Regions WHO Regional websites Africa Americas South-East Asia Europe Eastern Mediterranean Western Pacific When autocomplete results are available use up and down arrows to review and enter to select. (...) If you have used these falsified vaccines, or if you suffer an adverse event having used these vaccines, please seek immediate advice from a qualified healthcare professional, and ensure they report the incident to your local Ministry of Health/National Medicines Regulatory Authorities/National Pharmacovigilance Centre. All medical products must be obtained from authentic and reliable sources. (...) If you have any information concerning the manufacture, distribution, or supply of these vaccines, please contact: [email protected] Substandard and Falsified (SF) Medical Products All WHO Drug Alerts are available at the following link: http://www.who.int/medicines/publications/drugalerts/en/ To sign up for WHO Medical Product Alerts, please visit: http://www.who.int/about/licensing/rss/en/   Subscribe to our newsletters → Related Download pdf, 306kb Download full images Image 1 jpg, 72kb Image 2 jpg, 75kb Image 3 jpg, 56kb Image 4 jpg, 45kb Regions Africa Americas Eastern Mediterranean Europe South-East Asia Western Pacific Policies Cyber security Ethics Permissions and licensing Preventing sexual exploitation Terms of use About us Careers Library Procurement Publications Frequently asked questions Contact us Subscribe to our newsletters Privacy Legal Notice © 2022 WHO
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Score: 807244 - https://www.who.int/news/item/...medical-product-alert-n-1-2019
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It reiterates our commitment to quality medical products,” said Dr Renu Swarup, Secretary, Dept. of Biotechnology, Ministry of Science and Technology, Government of India. (...) It reiterates our commitment to quality medical products and reinforces our position of being the vaccine hub and pharmacy of the world. (...) The workshops are a follow on to the recommendations of the survey that called for strengthening GMP among SME manufacturers for access to quality medical products. “We are committed to the highest regulatory standards to ensure quality, safety and efficacy of medical products.
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Score: 807005.1 - https://www.who.int/southeasta...shops-for-pharmaceutical-units
Data Source: un
Some products may appear to have a medical purpose, but their purpose is to protect the user. Such products are considered as PPE rather than medical devices. (...) Download document Download file (PDF, 297,69 KB) Related topics Medical devices Global Denmark More to explore Page Technical standards and requirements Consult the international standards and regulatory frameworks that UNICEF applies to ensure the safety and quality of products for children.
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Score: 806684.13 - https://www.unicef.org/supply/...sonal-protective-equipment-ppe
Data Source: un
Speaking at the inaugural ceremony of the meeting, Dr Henk Bekedam, WHO Representative to India highlighted that WHO has been playing a pivotal role in supporting countries in strengthening their regulatory systems of medical products for human use, and in promoting equitable access to quality, safe, efficacious, and affordable medical products. (...) WHO’s role in strengthening regulatory systems WHO has been playing a pivotal role in supporting countries in strengthening their regulatory systems of medical products for human use, and in promoting equitable access to quality, safe, efficacious, and affordable medical products. Various World Health Assembly resolutions encompass aspects of the need to promote the quality, safety, efficaciousness and affordability of medical products. WHO is also moving towards strategic alliances for training and capacity-building, including development of Centres of Excellence for Good Regulatory Practices (GRP) in Member States.
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Score: 806391.8 - https://www.who.int/india/news...-regulatory-practices-in-india
Data Source: un
Annex 1 Annex 1: List of Medical Products[1] Medicines (Pharmaceuticals) HS 2017 Short product description ITA-E Pharma WCO 300213 Immunological products, unmixed, ... not for retail sale X 300214 Immunological products, mixed, ... not for retail sale X 300215 Immunological products, ... for retail sale X X 300219 Immunological products, n.e.s. X 300220 Vaccines for human medicine X 300310 Medicaments containing penicillins … not for retail sale X 300320 Medicaments containing antibiotics, … not for retail sale X 300331 Medicaments containing insulin, … not for retail sale X 300339 Medicaments containing hormones … not for retail sale X 300341 Medicaments containing ephedrine … not for retail sale X 300342 Medicaments containing pseudoephedrine "INN" or its salts, … not for retail sale X 300343 Medicaments containing norephedrine or its salts, … not for retail sale X 300349 Medicaments containing alkaloids or derivatives thereof, … not for retail sale X 300360 Medicaments containing any of the following antimalarial active principles: … not put up for retail sale X 300390 Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not for retail sale X 300410 Medicaments containing penicillins or derivatives thereof … for retail sale X 300420 Medicaments containing antibiotics, ... for retail sale X 300431 Medicaments containing insulin but not antibiotics, ... for retail sale X 300432 Medicaments containing corticosteroid hormones, ... for retail sale X 300439 Medicaments containing hormones or steroids ... for retail sale X 300441 Medicaments containing ephedrine or its salts, ... for retail sale X 300442 Medicaments containing pseudoephedrine "INN" or its salts, ... for retail sale X 300443 Medicaments containing norephedrine or its salts, ... for retail sale X 300449 Medicaments containing alkaloids or derivatives thereof... for retail sale X 300450 Medicaments containing provitamins, vitamins,... for retail sale X 300460 Medicaments containing any of the following antimalarial active principles ... for retail sale X 300490 Medicaments consisting of mixed or unmixed products ... for retail sale X X Medical Supplies HS 2017 Short product description ITA-E Pharma WCO 220710 Undenatured ethyl alcohol, of actual alcoholic strength of >= 80% X 284700 Hydrogen peroxide, whether or not solidified with urea X 300120 Extracts of glands or other organs or of their secretions, for organo-therapeutic uses X 300190 Dried glands and other organs for organo-therapeutic uses; heparin and its salts, … X 300212 Antisera and other blood fractions X 300290 Human blood; animal blood ...; toxins, cultures of micro‑organisms and similar products X 300510 Adhesive dressings and other articles ... put up for retail sale for medical, surgical, dental or veterinary purposes X 300590 Wadding, gauze, bandages and the like put up for retail sale for medical, surgical, dental or veterinary purposes X X 300610 Sterile surgical catgut, similar sterile suture materials,… X 300620 Reagents for determining blood groups or blood factors X 300630 Opacifying preparations for x-ray examinations; diagnostic reagents for administration to patients X 300650 First-aid boxes and kits X 300670 Gel preparations designed to be used in human or veterinary medicine … X 340212 Cationic organic surface-active agents 340213 Non-ionic organic surface-active agents 350400 Peptones and their derivatives; other protein substances and their derivatives, n.e.s.; … 350790 Enzymes and prepared enzymes, n.e.s. 370110 Photographic plates and film in the flat, sensitised, unexposed, for X-ray 370210 Photographic film in rolls, unexposed, for X-ray 380894 Disinfectants, put up in forms or packings for retail sale X 382100 Prepared culture media for the development or maintenance of micro-organisms 382200 Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents and certified reference materials X 392620 Articles of apparel and clothing accessories produced by the stitching or sticking together of plastic sheeting X 401490 Hygienic or pharmaceutical articles 401511 Surgical gloves, of vulcanised rubber X 401519 Gloves, mittens and mitts, of vulcanised rubber X 701710 Laboratory, hygienic or pharmaceutical glassware, of fused quartz or other fused silica 701720 Laboratory, hygienic or pharmaceutical glassware having a linear coefficient of expansion <= 5 x 10 -6 per kelvin within a temperature range of 0°C to 300°C 701790 Laboratory, hygienic or pharmaceutical glassware n.e.s 901831 Syringes, with or without needles, used in medical, surgical, dental or veterinary sciences X 901832 Tubular metal needles and needles for sutures, used in medical, surgical, dental or veterinary sciences X 901839 Needles, catheters, cannulae and the like, used in medical, surgical, dental or veterinary sciences X Medical Equipment HS 2017 Short product description ITA-E Pharma WCO 841920 Medical, surgical or laboratory sterilizers X 901050 Apparatus and equipment ....; negatoscopes X 901110 Stereoscopic optical microscopes X 901180 Optical microscopes X 901811 Electro-cardiographs X 901812 Ultrasonic scanning apparatus X 901813 Magnetic resonance imaging apparatus X 901814 Scintigraphic apparatus 901819 Other electro-diagnostic apparatus X X 901820 Ultraviolet or infra-red ray apparatus used in medical, surgical, dental or veterinary sciences X 901890 Instruments and appliances used in medical, surgical or veterinary sciences, n.e.s. X X 901920 Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus X 902150 Pacemakers for stimulating heart muscles X 902212 Computer tomography apparatus X X 902214 Apparatus based on the use of X-rays, for medical, surgical or veterinary uses X 902219 Apparatus based on the use of X-rays X 902221 Apparatus based on the use of alpha, beta or gamma radiations, for medical, surgical, dental or veterinary uses X 902229 Apparatus based on the use of alpha, beta or gamma radiations, n.e.s X 902230 X-ray tubes X 902290 X-ray generators, high tension generators, control panels and desks, screens, … X 902511 Thermometers, liquid-filled, for direct reading, not combined with other instruments X 902519 Thermometers and pyrometers, not combined with other instruments X X 902780 Instruments and apparatus for physical or chemical analysis, or for measuring or checking viscosity … X X 903020 Oscilloscopes and oscillographs X 940290 Operating tables, examination tables, and other medical, dental, surgical or veterinary furniture Personal Protective Products HS 2017 Short product description ITA-E Pharma WCO 340111 Hand soap 340130 Hand soap 340220 Other cleaning products 382499 Hand sanitizer 392690 Face masks 630790 Face masks X 900490 Protective spectacles and visors X 902000 Face masks X [1] Columns "ITA-Exp", "Parma", and "WCO" indicate if the HS codes are also part of the ITA Expansion, Pharmaceutical Agreement, or WCO HS Classification reference for Covid-19 medical supplies Annex 2 Annex 2: Latest Average Applied MFN Tariff (%) for Medical Products WTO Member All products Medicines Medical Supplies Medical equipment Personal protective products ALL WTO Members 4.8 2.1 6.2 3.4 11.5 Albania 0.6 0 1 0 3.3 Angola 1.8 0 1.2 0.4 14.4 Antigua and Barbuda 7 4.8 5.2 8.6 14.5 Argentina 9.9 7.7 11.4 8.4 16.5 Armenia 3.2 0.3 6.9 1.6 2.8 Australia 1.5 0.3 2.7 0.4 3.9 Bahrain, Kingdom of 2.8 0 3.1 4.7 5.3 Bangladesh 5.8 3.2 7.9 1.6 19.8 Barbados 8.1 5.3 7.4 8.6 14.4 Belize 7 1.5 8.3 8.6 14.8 Benin 5.3 0 6.1 5.6 18.8 Bolivia, Plurinational State of 7.5 5.7 8.7 5.4 15.3 Botswana 2.7 0 5.1 0 10.8 Brazil 9.8 7.8 11 8.4 16.6 Brunei Darussalam 0.2 0 0 0.2 1.7 Burkina Faso 5.3 0 6.1 5.6 18.8 Burundi 2.6 0 2.8 0.9 15.3 Cabo Verde 3.2 1.1 2.9 0.4 20.5 Cambodia 3.6 0 4.2 5.2 8.6 Cameroon 6.6 0.8 7.7 6.8 20.5 Canada 2.4 0 5.7 0.1 4.3 Central African Rep. 8.8 5 9.1 6.8 21 Chad 8.7 5 9.1 6.8 20.8 Chile 6 6 6 6 6 China 4.5 2.1 7.4 2.5 7.2 Colombia 4.7 5.7 5.4 0.7 10.8 Congo 8.7 5 9.1 6.8 20.8 Costa Rica 1.9 1.7 2.1 0.1 7.6 Côte d'Ivoire 5.3 0 6.1 5.6 18.8 Cuba 7.8 0.8 8.7 10.4 19.6 DR of the Congo 9.1 10.5 10.2 5.2 14.2 Djibouti 20 8 19.9 26 26 Dominica 7 0 5.2 7.6 25.8 Dominican Republic 2 0 2 0.3 13.5 Ecuador 5.4 3.5 5.8 2.5 18.5 Egypt 5.8 1.5 5.1 4.2 27.6 El Salvador 2.5 2.2 3.4 0.1 7 Eswatini 2.7 0 5.1 0 10.8 European Union 1.5 0 3.2 0.2 3.9 Fiji 14.8 0 36.1 1.7 18.5 Gabon 5.6 0 6.6 3 21 Georgia 0.7 0 0.9 0 3.5 Ghana 5.3 0 6.1 5.6 18.8 Grenada 7.5 4.3 5.7 8.6 17.4 Guatemala 2.8 3.3 3.5 0.1 7 Guinea 5.3 0 6.1 5.6 18.8 Guinea-Bissau 5.3 0 6.1 5.6 18.8 Guyana 8.3 5.3 8.1 8.6 14 Haiti 2.6 0 1.6 1.6 14.6 Honduras 1.8 0.9 2.7 0.1 7 Hong Kong, China 0 0 0 0 0 Iceland 0 0 0 0 0 India 11.6 10 15 9 12 Indonesia 5.2 3.8 5.5 4.5 10.5 Israel 1.7 2.3 1.8 1.1 1.4 Jamaica 6.8 5.1 4.9 7.2 16.3 Japan 0.4 0 0.8 0 1.8 Jordan 3.6 0 3.9 3.4 15.1 Kazakhstan 5.3 0.2 13 1.1 5.2 Kenya 2.6 0 2.8 0.9 15.3 Korea, Republic of 5.9 6.9 8.1 1.5 7.1 Kuwait, the State of 3.1 0 3.1 4.6 5 Kyrgyz Republic 0.6 0 0.9 0 2.8 Lao PDR 7.3 9.4 6.5 5.4 12.1 Lesotho 2.7 0 5.1 0 10.8 Liberia 5.3 0 6.1 5.6 18.8 Macao, China 0 0 0 0 0 Madagascar 3.3 0 5.2 1.5 12 Malawi 3.9 0 5.1 0.8 17.2 Malaysia 11.7 0 32 0.3 6 Maldives 6.9 0 9.3 10.3 9.9 Mali 5.3 0 6.1 5.6 18.8 Mauritania 5.2 0 5.6 5.6 12.7 Mauritius 0.6 0 0.7 0 3.8 Mexico 4.6 5.5 5.1 2.3 8.1 Moldova, Rep 2.1 0 2.8 1.6 5.3 Mongolia 4.1 5 4.7 2.2 5 Montenegro 0.8 0 1.2 0 4.3 Morocco 7.1 9 7.7 2.5 12.3 Mozambique 4.1 0 4.3 5.5 12.8 Myanmar 3.1 1.2 4.1 2.9 6 Namibia 2.7 0 5.1 0 10.8 Nepal 9.4 12 9.5 4.8 14.7 New Zealand 0.8 0 0.9 0.8 3 Nicaragua 1.8 0 3.1 0.1 7.6 Niger 5.3 0 6.1 5.6 18.8 Nigeria 5.3 0 6.1 5.6 18.8 North Macedonia 1.3 1.2 0.9 0.2 6.9 Norway 0.6 0 1.7 0 0 Oman 2.7 0 3 4.6 5 Pakistan 10 10.9 13.4 3.6 13.1 Panama 1.6 0 2.2 1.3 5.5 Papua New Guinea 0.8 0 0.5 0 6.8 Paraguay 7.4 7.5 10 2.3 13 Peru 2.1 2.7 2.3 0.4 5.2 Philippines 2.5 2.2 3.4 0.4 7.1 Qatar 2.7 0 3 4.6 5 Russian Federation 3.2 2.3 4.8 1.8 4.7 Rwanda 2.4 0 2.8 0.9 13.8 Saint Kitts and Nevis 8.3 1.6 9.1 8.4 18.3 Saint Lucia 6.3 3.8 4.2 7.2 17 Saint Vincent & the Grenadines 7.3 3.6 5.6 8.6 17.7 Samoa 6.1 0 6.6 8 10.3 Saudi Arabia 4.1 0 4.5 4.6 8.7 Senegal 5.3 0 6.1 5.6 18.8 Seychelles 0.2 0 0 0 1.9 Sierra Leone 5.3 0 6.1 5.6 18.8 Singapore 0 0 0 0 0 Solomon Islands 16.9 5 30.7 9.8 9.4 South Africa 2.7 0 5.1 0 10.8 Sri Lanka 11 0 25.6 0 11.2 Suriname 7.9 5.3 6.5 8.6 16.5 Switzerland 0.7 0 0.8 0 5.2 Chinese Taipei 1.4 0.1 2.7 0.1 4.4 Tajikistan 17.3 4.7 36.6 4.8 6.9 Tanzania 2.6 0 2.8 0.9 15.3 Thailand 7.2 7.6 11.9 0.8 7.4 The Gambia 5.3 0 6.1 5.6 18.8 Togo 5.3 0 6.1 5.6 18.8 Tonga 4.7 0 7.6 2.7 9.4 Trinidad and Tobago 6 4.3 4.3 6.6 13.8 Tunisia 5.1 8.8 5.4 0 12.9 Turkey 2 0 3.9 1 4 Uganda 2.7 0 2.5 1.1 17.8 Ukraine 1.8 0 2.6 1.2 4 United Arab Emirates 3.1 0 3.1 4.6 5 United States 0.9 0 2 0.1 2.1 Uruguay 7.8 7.7 10.2 2.3 15.4 Vanuatu 3.1 0 4.7 0.4 15.6 Venezuela 10.8 8.8 12 8.5 17.7 Viet Nam 2.8 0.8 4.3 0.2 11.4 Yemen 5.4 4.7 5.4 5 7.7 Zambia 3.8 0 2.6 4 15.8 Zimbabwe 7.1 3.7 10.7 2.2 18.8
Language:English
Score: 806326.95 - https://www.wto.org/english/tr..._e/medical_good_annexes_e.xlsx
Data Source: un
Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade, 2nd edition 334 Promoting Access to medicAl technologies And innovAtion List of figures, tables and boxes Chapter I Figures Figure 1.1 Leading causes of disease burden in DALYs in 2000 and 2016 globally 34 Figure 1.2 Leading causes of death in 2000 and 2016 globally 34 Figure 1.3 Global burden of disease ranking, 1990 and 2017 35 Figure 1.4 The distinct policy domains of public health 37 Figure 1.5 Policy intersections between distinct levels 38 Boxes Box 1.1 WHO–WIPO–WTO technical symposia 32 Box 1.2 The disability-adjusted life year (DALY) 33 Box 1.3 Health and medical technologies: fundamental concepts 39 Chapter II Figures Figure 2.1 Key challenges in implementing national action plans 52 Figure 2.2 Stewardship, innovation and access: a delicate balance of conflicting goals 52 Figure 2.3 Illustration of terms of patent protection and regulatory exclusivities 61 Figure 2.4 Growth of the top four technology fields, 2000–2019 79 Figure 2.5 PCT applications in the field of medical technology, including pharmaceuticals, 2000–2019 79 Figure 2.6 Main countries of origin of PCT publications in the field of medical technology, including pharmaceuticals, 2000–2019 80 tables Table 2.1 Information available in MedsPaL and Pat-INFORMED 75 Table 2.2 Examples of search parameters for pharmaceutical substances 77 Table 2.3 Number of GATS commitments 101 Table 2.4 Coverage in the health sector by parties to the WTO GPA 104 Boxes Box 2.1 Selected reports on access to medicines and R&D 47 Box 2.2 The Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property 50 Box 2.3 CRISPR-Cas9 gene-editing technology 58 Box 2.4 CAR T-cell therapy 58 Box 2.5 Selected types of US regulatory exclusivity 60 Box 2.6 The Paris Convention 64 Box 2.7 TRIPS and public health: key milestones 65 Box 2.8 The Patent Cooperation Treaty 67 Box 2.9 Societal and moral values in the patent system 69 335 list oF Figures, tABles And Boxes Box 2.10 WIPO Standing Committee on the Law of Patents 73 Box 2.11 Selected databases 75 Box 2.12 The example of colchicine 83 Box 2.13 The Madrid System for the International Registration of Marks 84 Box 2.14 Artificial intelligence and health 89 Box 2.15 Definition of flexibilities according to WIPO 92 Box 2.16 TRIPS flexibilities highlighted in the GSPA-PHI and Road Map for Access to Medicines, Vaccines and Other Health Products, 2019–2023 92 Box 2.17 The example of Cambodia: an LDC’s terms of accession to the WTO 95 Box 2.18 Merger control in the European Union 97 Box 2.19 Antimicrobial resistance in the SPS Committee 100 Box 2.20 Product patents and access to innovative medicines in a post-TRIPS era 110 Box 2.21 The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (Nagoya Protocol) 115 Chapter III Figures Figure 3.1 Approvals of medicines by the US Food & Drug Administration, 1944–2019 135 Figure 3.2 Global R&D expenditures, PCT international application publications on pharmaceuticals and novel drug approvals in the United States, 2004–2019 135 Figure 3.3 Novel drug approvals, percentage with orphan designation and R&D expenditure as percentage of sales, 1999–2019 136 Figure 3.4 Patent publications by technology: performance by sector, income group and world, 1980–2017 137 Figure 3.5 Top countries of origin of PCT publications in the field of pharmaceuticals, 1996– 2019 139 Figure 3.6 The innovation cycle 144 Figure 3.7 Timeline of the discovery of different antibiotic classes in clinical use 153 Figure 3.8 Number and sales values of PRVs 160 tables Table 3.1 PRVs issued, 2009–2019 159 Table 3.2 Pharmaceutical industry centres dedicated to NTDs R&D 164 Table 3.3 IP issues that may arise at each stage of the product development pipeline 167 Table 3.4 The different roles of patents in the medical devices industry and the pharmaceutical industry 169 Table 3.5 Summary of benefit-sharing options under SMTA 2 182 Boxes Box 3.1 IP and licensing in the discovery of insulin 134 Box 3.2 Adaptation of medical devices to developing-country needs – the example of portable electrocardiographs 141 Box 3.3 Monoclonal antibodies 142 Box 3.4 New innovation models in practice: tailoring a meningitis vaccine for Africa 146 336 Promoting Access to medicAl technologies And innovAtion Box 3.5 Advance market commitments in vaccines 147 Box 3.6 European Medicines Agency makes available clinical trials data 150 Box 3.7 Initiatives to revitalize the antimicrobial pipeline 154 Box 3.8 WHO R&D Blueprint for Action to Prevent Epidemics: priority list as at February 2018 155 Box 3.9 2012 CEWG report: key recommendations 155 Box 3.10 Unitaid 157 Box 3.11 Examples of prize schemes 157 Box 3.12 Examples of successful product development partnerships 162 Box 3.13 Patenting products of nature – the Myriad case 170 Box 3.14 Examples of drug-device combinations 172 Box 3.15 How India defines and applies patentability criteria 174 Box 3.16 Second use patents: the case of fluoxetine 175 Box 3.17 WIPO Patent Search Report on PIP-Related Patents and Patent Applications 181 Chapter IV Figures Figure 4.1 The WHO Health System Framework 193 Figure 4.2 The three dimensions of universal health coverage 194 Figure 4.3 Ensuring access along the value chain of medicines and health products 195 Figure 4.4 Local production and access to essential medical products: a framework for improving public health 211 Figure 4.5 Sales revenue per year of generic and originator ARVs in LMICs 218 Figure 4.6 Sales quantities per year of generic and originator ARVs in LMICs 219 Figure 4.7 Challenges in access to AMR-related technologies in LMICs 220 Figure 4.8 Detention of generic medicines in transit by EU Customs 251 Figure 4.9 Evolution of IP chapters in FTAs: developments from 2000 to 2019 257 Figure 4.10 Imports of health-related products 1995–2018, by value (in US$ million) and compound growth rates, 2018 264 Figure 4.11 Per capita imports of pharmaceutical formulations 1995–2018 267 Figure 4.12 Tariffs on health-related products: simple applied average versus WTO simple bound average rates, by product category, 2018 268 tables Table 4.1 Selected country experiences with compulsory licences and government-use licences 239 Table 4.2 Comparison of expected patent expiry dates and dates of SPC expiry in France, for selected medicines on the WHO EML 249 Table 4.3 Provisions in selected FTAs with a bearing on access and innovation in the pharmaceutical sector 253 Table 4.4 Public-health-related products 263 Table 4.5 International trade in health-related products: share of main importers, 2018 264 Table 4.6 International trade in health-related products: share of main exporters, 2018 265 Table 4.7 Net exporters of pharmaceutical products (categories A1, A2, A3), average 2016–2018 266 337 list oF Figures, tABles And Boxes Table 4.8 Net importers of pharmaceutical products (categories A1, A2, A3), average 2016–2018 266 Table 4.9 Share of health product imports in total national imports, 2018 267 Boxes Box 4.1 The US Hatch-Waxman Act as a supply-side measure to encourage generic competition 197 Box 4.2 Price control and reference prices to reduce prices of medicines in Colombia 199 Box 4.3 Examples of databases of medicines prices 202 Box 4.4 Differential packaging 203 Box 4.5 Authorized generics 203 Box 4.6 The WHO Model List of Essential Medicines 205 Box 4.7 Cost reduction/improvements in value for money in the health-care sector through centralized procurement: the example of Ecuador 207 Box 4.8 Examples of European pooled procurement initiatives: the Beneluxa Initiative and the Joint Procurement Mechanisms 208 Box 4.9 Developing local production capacities in Ghana: support measures and challenges 210 Box 4.10 Europe: tightening controls to guarantee the safety of medical devices 212 Box 4.11 WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products 216 Box 4.12 Innovative Medicines for Tuberculosis (iM4TB) Foundation 221 Box 4.13 WHO, Pricing of Cancer Medicines and its Impacts (2019) 222 Box 4.14 Access to insulin 223 Box 4.15 Buyers’ clubs 225 Box 4.16 Gavi, the Vaccine Alliance 226 Box 4.17 Precision medicine and the patentability of diagnostic and treatment methods 231 Box 4.18 Guidelines for the examination of pharmaceutical patents: developing a public health perspective 232 Box 4.19 The US Patent Trial and Appeal Board 234 Box 4.20 Government-use licences: efavirenz and lopinavir/ritonavir in Thailand 236 Box 4.21 Government-use licences: hepatitis C treatment in Malaysia 237 Box 4.22 Compulsory licences as a litigation tool 239 Box 4.23 Case study on supply of ARVs to Rwanda 243 Box 4.24 The Medicines Patent Pool 245 Box 4.25 Access to Medicine Index 246 Box 4.26 Cases under IIAs and FTAs 260 Box 4.27 The emergence of global value chains 265 Box 4.28 How tariff reductions can save human lives: the example of mosquito nets 268 Box 4.29 Sectoral tariff negotiations in the GATT and the WTO 269 Box 4.30 The WTO Trade Facilitation Agreement 270 Box 4.31 Competition investigation into strategic patenting – cases from South Africa 271 Box 4.32 Action against sham litigation in the pharmaceutical sector in Brazil 272 Box 4.33 Landmark reverse patent settlement ruling by the Supreme Court of the United States and subsequent developments 272 338 Promoting Access to medicAl technologies And innovAtion Box 4.34 The European Union’s Guidelines on Technology Transfer Agreements, monitoring and enforcement against reverse patent settlements in the pharmaceutical sector 273 Box 4.35 Competition law enforcement against a reverse patent settlement in the Republic of Korea 273 Box 4.36 Abuse of dominance in South Africa 273 Box 4.37 Applying competition law to generic manufacturers 275 Box 4.38 General approaches to “excessive pricing” in domestic laws 275 Box 4.39 Examples of “excessive pricing” cases concerning pharmaceuticals 275 Box 4.40 Jurisprudence on competition authority scrutiny to enable competition through off-label use 276 Box 4.41 Hospital merger in Brazil 276 Box 4.42 The 2019 Health Market Inquiry of the Competition Commission of South Africa 277 Annexes tables Resolutions of the UN General Assembly and UN Human Rights Council Key Reports of the UN Special Rapporteur on the Right to Health 292 Selected Resolutions and Decisions of the World Health Assembly 298 Special Compulsory Licences for Export of Medicines 302
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Score: 806151.95 - https://www.wto.org/english/re...igures_who-wipo-wto_2020_e.pdf
Data Source: un