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MeTa, Solwezi 27 August,2013 Slide 2 A branded- name drug product is originally discovered and developed by a pharmaceutical company. Branded-name drugs are marketed exclusively by the innovator company. A branded drug is an intellectual property,therefore it is patented. A Patent may have duration of up to 20 years. Slide 3 Branded-name drugs are labelled under Trade/Proprietory names and the manufactures name. Coartem(Artemether/Lumefantrine)-Novartis Viagra(Sildenafil Citrate)-Pfizer Slide 4 Generic drugs are copies of branded-name drugs with the same high quality,purity,strenghth and intended use as branded-name drugs. The term Generic drug also referrers to any drug marketed under its chemical name without advertising. Slide 5 Generic drugs are labelled under an adopted name(non-proprietary name) and the manufacturers name. Generic drugs are manufactured and Sold by other pharmaceutical companies, after the patent for the innovator company has expired. Slide 6 Contain the same active ingredient. Have the same strength Same dosage form(tablet, suspension or injection). Same route of administration(oral, injectable) Both attain the same blood concentration after intake(Bioequivalent). Slide 7 Branded-name and Generic drugs have to pass through the same quality standards required by the drug regulation authority. Slide 8 Inactive ingredients Shape Colour Taste Preservatives Packaging labelling Slide 9 1.Advantages Easily accessible. Affordable. Inc increase access to health care for the majority. 2.Disadvantages Not all branded name drugs have generic counterparts Slide 10 Some patients are brand-name specific Slide 11 Substandard medicines are products whose composition and ingredients does not meet correct scientific specifications and which are consequently ineffective and often dangerous to the patient. Causes of Substandard medicines Negligence during manufacture, distribution and storage. Slide 12 Human error Insufficient human resource Financial resources Counterfeiting Slide 13 Counterfeit medicines are Substandard medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source. All counterfeit medicines are substandard, but not all substandard medicines are counterfeit. Types of counterfeit medicines; Slide 14 Products with correct active ingredient but fake packaging. Products with wrong ingredients(active/inactive). Products without active ingredients. Products with insufficient active ingredients. Counterfeiting can apply to both Branded- name and Generic medicines. Slide 15 Poverty-high prices of medicines and high price differentials between identical. High demand. Low production costs. Absence of deterrent legislation. Slide 16 In developed countries: New drugs Expensive lifestyle medicines- hormones,steroids,antihistamines In developing countries; Those that are used to treat life threatening conditions such as Malaria,Tuberculosis and HIV/AIDs. Slide 17 The internet is also becoming one of the major sources of counterfeit medicines. Of all drugs in the world,Viagra is the most counterfeited medicine. Slide 18 Treatment failure. Drug resistance-resulting from drug resistant pathogens. Most cases leading to death. Slide 19 Counterfeit medicines make up 10% of the global medicines market and are present both in developed and developing countries. 25% of the medicines consumed in poor countries are counterfeit or substandard. Global earnings from counterfeit medicines is over $32 billion dollars annualy. Slide 20 Where ; Drug regulation and control is weak. Enforcement scarcity Supply of medicines is erratic Drug markets are unregulated Medicine prices are unaffordable The countries include those in Africa, south America and south east Asia. Slide 21 Lack of regulation and enforcement- smuggling and illegal importation. increasing national and international trade in alternative medicines/herbal medicines- herbal medicines are highly unregulated Some policy makers believe drug regulation presents unnecessary barrier to trade and should be reduced to minimum. Slide 22 Medicines exported from industrialised countries are not regulated to the same level as those consumed domestically. Slide 23 Establishing competent national drug authorities with necessary human and other resources to control the manufacture,importation,distribution and sale of medicines. Government to develop strategies to reduce corruption and criminal activity and promote intersectoral cooperation between regulatory Slide 24 authorities, the police,customes services and the judiciary to effectively control the drug market and enforce regulation. Increasing public awareness. Harmonizing measures between trading countries. Pre-qualification-Assessing products and manufactures and,providing a list of those Slide 25 meeting WHO guidelines to countries and procurement agencies, in order to promote procurement of quality medicines.