PaRCha - JNU - AISA material - 2007 ID-17489
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No. It would not meet the needs of poor people as no generic manufacturer would be able or willing to comply with the onerous provisions of the statement. .
Can you tell us what these provisions are? .
The drug pact clearly represented the clout of the US Pharma lobby and have ensured that the poor paid more for generic medicines. Some of the safeguards are technically not feasible/cost effective. .
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The size and shape of a tablet depends on the formulation technology. The size, being related to the weight of the tablet, is directly related to the bioequivalence and bioavailability of the product. .
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The size, shape and colouring of the product will increase cost of production. For example, a 100 mg (size) white (colour) round (shape) tablet if required to be made in different dimensions, the alterations will require additional excipients to alter size, colouring agent for colour, and any shape other than round will reduce the output of the machine. .
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In addition, if a brand name company is selling the same product under different size, shape and colouring in its differently priced markets, as for instance being quoted in the example of Novartis, the options available to generic companies will be limited. .
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It is not feasible to distinguish the API (bulk drug) by colour/shape or size. .
.
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Hence, the demand for 'special colouring/shaping of the products' for most commonly used colour (white), shaped (round), and size should not have been accepted. The generic industry cannot afford to export for humanitarian reason alone. It has to be for pursuing commercial objectives. However, where the originator has developed a special shape/colour as in the case of Valium of Roche or Viagra of Pfizer, the products under licence should be distinguished. Further, the product differentiation should be restricted to brand name and packaging materials (the licensee should not use the brand name and packaging material colour scheme and design of the licensor) only. .
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How many new rules in this WTO-deal do you need to apply to? .
The procedures included in the statement (a) require the importing country to establish its eligibility; (b) enable the TRIPS Council to review the notifications of the importing and the exporting countries; and (c) provide scope for frivolous complaints against generic suppliers. All these add undue risks to the generic supplier over and above the risk of uncertainties associated with the development of process for new molecule, as generic version may not be readily available post-2005. .
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Is there a chance that your generic medicines will appear on western markets, like countries as the USA are afraid of? .
No. It is unfortunate that there is so much attention on trade diversion. This concern is disproportionate to the potential problem of diversion of generic pharmaceutical products. It must be pointed out that there has not been an actual case of generic drugs .
.
.
PaRCha - JNU - AISA material - 2007 ID-17489
.
No. It would not meet the needs of poor people as no generic manufacturer would be able or willing to comply with the onerous provisions of the statement. .
Can you tell us what these provisions are? .
The drug pact clearly represented the clout of the US Pharma lobby and have ensured that the poor paid more for generic medicines. Some of the safeguards are technically not feasible/cost effective. .
.
The size and shape of a tablet depends on the formulation technology. The size, being related to the weight of the tablet, is directly related to the bioequivalence and bioavailability of the product. .
.
.
The size, shape and colouring of the product will increase cost of production. For example, a 100 mg (size) white (colour) round (shape) tablet if required to be made in different dimensions, the alterations will require additional excipients to alter size, colouring agent for colour, and any shape other than round will reduce the output of the machine. .
.
.
In addition, if a brand name company is selling the same product under different size, shape and colouring in its differently priced markets, as for instance being quoted in the example of Novartis, the options available to generic companies will be limited. .
.
.
It is not feasible to distinguish the API (bulk drug) by colour/shape or size. .
.
.
Hence, the demand for 'special colouring/shaping of the products' for most commonly used colour (white), shaped (round), and size should not have been accepted. The generic industry cannot afford to export for humanitarian reason alone. It has to be for pursuing commercial objectives. However, where the originator has developed a special shape/colour as in the case of Valium of Roche or Viagra of Pfizer, the products under licence should be distinguished. Further, the product differentiation should be restricted to brand name and packaging materials (the licensee should not use the brand name and packaging material colour scheme and design of the licensor) only. .
.
How many new rules in this WTO-deal do you need to apply to? .
The procedures included in the statement (a) require the importing country to establish its eligibility; (b) enable the TRIPS Council to review the notifications of the importing and the exporting countries; and (c) provide scope for frivolous complaints against generic suppliers. All these add undue risks to the generic supplier over and above the risk of uncertainties associated with the development of process for new molecule, as generic version may not be readily available post-2005. .
.
Is there a chance that your generic medicines will appear on western markets, like countries as the USA are afraid of? .
No. It is unfortunate that there is so much attention on trade diversion. This concern is disproportionate to the potential problem of diversion of generic pharmaceutical products. It must be pointed out that there has not been an actual case of generic drugs .
.
.