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External sources (not reviewed)

Potential compulsory licensees would therefore have to charge a price closer to full economic cost (including start-up and manufacturing costs) as compared to the possibility of providing off-the-shelf generics at prices where start-up costs have already been amortised to some extent on the domestic market.

A crucial finding is that the full benefits of competition will only be felt at quite large market sizes – in smaller markets fewer generic firms will consider the market worth entering and prices to consumers will be higher.

[...] [...] produce and export generic copies of patented drugs.

When all producer countries have patent laws, generics will increasingly be limited to older off-patent drugs.

In Italy and Canada, two developed countries, the evidence is mixed.55 In Italy multinational [...] [...]

[...] of whether the drug was patented, or the patent period has [...]

[...] ensure collaboration between patent owners and generic manufacturers, [...] [...]

Pharmaceutical companies have also brought or defended expensive court actions to delay or prevent generic entry and to protect or extend a monopoly on a best selling drug.45 [...] [...]

On the one hand, manufacturers of mainly generic drugs are likely to be adversely affected by the introduction of patent protection, and also consumers and governments who will need to pay more for drugs that receive patent protection.

It is your choice whether you buy the generic brand of medication [...]

[...] [...] provided on a non-proprietary and non-confidential basis, [...] [...]

The minimum annual costs of ARV therapies, even at deeply discounted or generic prices which do not cover R&D costs, far exceed the annual health expenditure per capita of most developing countries.

[...] [...] environment for both patented and generic products that makes the existence of [...] [...]

As the world’s leader in the production of generic drugs, India has taken the lead in providing affordable, first-line antiretroviral drugs used to treat people living with HIV.

[...] would be an issue when TRIPS came into force for all WTO members.39 Although the overall prevalence of patents found in the study is relatively low in aggregate, it is perhaps surprising that it [...]

Note with concern that regulations, policies and practices, including those that limit legitimate trade in generic medicines, may seriously limit access to affordable HIV treatment and other pharmaceutical products in low- and middle-income countries, and recognize that improvements can be made, inter alia through national legislation, regulatory policy and supply chain management, noting that reductions in barriers to affordable products could be explored in order to expand access to affordable and good quality HIV prevention products, diagnostics, medicine and treatment commodities for HIV, including for opportunistic infections and co-infections

International institutions, such as WHO or the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) may also have an essential role to play in facilitating and financing group purchases of medicines from both brand and generic manufacturers.

[...] [...] affordable medicines, including generics, and of increased access [...] [...]

The growth of the pharmaceutical industry in India was in danger due to international rules; therefore, it was urgent to revisit domestic regulations to determine to what extent they could provide space for generic industries to provide new drugs.

Moreover, from a societal point of view, it makes no sense for a potential generic competitor to repeat very expensive tests if the biopharmaceutical equivalence of their version of the drug can be reliably demonstrated.

A study conducted in some low-income countries revealed that up to two thirds of generic medicines were not freely available in the public sector and almost 50 per cent were not available in the private sector.

The support of relevant international organizations and partners to increase technical assistance, transfer of technology, capacity-building and access to high quality generic medicines would enhance national efforts in tackling NCDs.

[...] [...] (b) $35,281,900 for non-post requirements, reflecting a net increase of $3,343,800, for, inter alia, other staff costs, including requirements for general temporary assistance to assist in carrying out a variety of ICT services related to infrastructure, resource and knowledge management; travel of staff; contractual services, including data-processing services and proprietary software costs [...] [...]

[...] [...] Middle East, Europe and North Africa (Spain, Italy, the United Kingdom, Morocco, Tunisia, Lebanon, the Occupied Palestinian Territory, Israel, Latvia, Croatia, Slovenia, Romania, Czech Republic, Hungary and the Russian Federation), 37 representatives of non-governmental organizations, regional Governments, think tanks, and experts in cooperation for development.

The delegation of the Islamic Republic of Iran was of the view that affordable antiretroviral treatment (generic drugs) should be provided to all people living with HIV, including through assistance by developed countries, and that intellectual property rights should not hinder access to such treatment.

[...] [...] dueprocess rights of staff members: (a) the length of the investigation process and the number of entities involved in investigations, as well as the quality of fact-finding and other inquiries conducted by non-professional investigators; [...] [...]