Transcript Presentation

Issues related to poor IP protection in EMs:
Pharmaceutical Example
Rob May
Commercial Director,
Janssen, EMEA Emerging Markets
Innovation in the Pharmaceutical Industry*
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New drug development takes an average of 10–15 years
Cost of drug development has risen from an average $800M per drug in 2003 to $2.6B in 2014
Pharmaceutical companies invest 17-22% of sales into R&D; other manufacturing companies
usually invest <5%
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A strong intellectual property rights system encourages investment in innovation
Pharmaceutical innovation has accounted for 73% of the total global
increase in life expectancy between 2000 and 2009
*Pharmaceutical Research & Manufacturers of America
Issue 1: Loss of Sales / Access to Medicines
• Length of IP / data exclusivity only allows for short period of time to
recoup cost of R&D and make profit
• Innovative R&D companies expect generic companies to enter markets a
significantly lower prices once IP has ended
• Without protected IP rights in country:
– Innovative R&D companies may choose not launch products in country
– This could reduce access to important medicines
Example: India
– Courts have denied innovative R&D companies patent protection for many
innovative products
– Public health is used as a pretext for giving domestic drug makers a ‘free ride’ on
innovative R&D
Example: Sub-Saharan Africa
– Indian / Chinese generics allowed to enter markets by regulators, prior to original
products entering
– PMGMAN estimate that the cost of IP infringement to the pharmaceutical sector in
Nigeria is US$ 233 million
Issue 2: Counterfeit
• Unless strong IP rights and regulations in place, counterfeit
will proliferate
The Health and Economic Effects of Counterfeit Drugs, Am Health Drug Benefits. 2014
Issue 3: Product Quality & Safety
• Safe, effective and high-quality medical products are essential to positive
and equitable health outcomes for all
• Counterfeit and poor quality medicines are a real and urgent threat to
human health, now becoming a pandemic problem; including the
undermining of decades of successful efforts to combat HIV/AIDS, malaria,
TB
– Scientists report up to 41% of specimens failed to meet quality standards in global
studies
– In 2013, an estimated 122,350 deaths in children under 5 years of age in 39 sub-Saharan
African countries were associated with the consumption of poor-quality antimalarials,
representing 4% of all under-five deaths
– Leading to increased morbidity and mortality when no active ingredient is present
– Increased microbial resistance, when active drug is in low amounts in the product
– Socioeconomic losses and loss of public trust are associated with poor-quality
medicines, all of which jeopardize years of global public health success and investments
American Journal of Tropical Medicine and Hygiene, “The pandemic of falsified medicines, 2015
Conclusion
• Upholding IP rights through strong policy, enforced
regulation and including the prosecution of
counterfeiters will:
– Ensure patients receive quality products enhancing health
and well-being of populations
– Increase access to needed innovative medicines in
Emerging Markets