[e-drug] ARV local production costs

e-drug
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E-DRUG: ARV local production costs
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Dear colleagues and e-druggers-

During a series of discussions (I'm a visiting scientist at Bonn University) on the best way to ensure availability of ARVs at affordable prices to patients in Central Asian/in general CIS countries, I expressed my doubts that it will be cheaper to manufacture ARVs locally than to buy these commodities from International generic companies, Donor organisations, etc.
Unfortunately nobody could present appropriate, relevant data on the real, pure production costs of ARVs for both cases. However, as the costs for the APIs will take the lions share, and in such countries there are almost no API manufacturers, the advantages of local manufacturing might be very small.

In addition, the necessary equipment, trained personnel, etc. needs to be taken into account.
My question is: is someone aware of a published comparison of the ARV production costs locally versus the procurement via International suppliers, like generic firms, Donor organisations, etc.?

Thank you for your support: I think the answer to this question will be interesting for many colleagues!

Best regards / Mit freundlichen Grüßen

Dr. Werner Gielsdorf
Visiting scientist Bonn University
Germany
"mail@gielsdorf.org" <mail@gielsdorf.org>

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E-DRUG: ARV local production costs (2)
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Dear Werner,

It very obvious that local production may not necessarily be cheaper, nor may it end up with quality products meeting international standards.

For the first, very important is scale as only large volume production can give affordable prices and be also able to pay for the quality. One indicator for prices to use would be the prices that Global Fund pays for ARVs - and they buy only quality assured products from manufacturers with high volumes of production.

Last but not least. As you rightly mention a lot of the price comes from API and APIs nowadays are 80% plus manufactured in India and China. Also in case of APIs quality API sources are more expensive than those without proven quality. You may also wish to know that in China there two pools of API manufactures - one which is under supervision Chinese regulator CFDA and another one which is not. The Chinese manufacturers by the way are allowed to buy only from the first pool.

Hoping it helps,

Kind regards,

Lembit

Lembit Rägo MD, PhD
Head, Regulation of Medicines and other Health Technologies
Essential Medicines and Health Products
World Health Organization
Geneva
Switzerland
Tel. +41 22 791 4420
"RAGO, Lembit" <ragol@who.int>

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E-DRUG: ARV local production costs (3)
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Colleagues,
Local production of any pharmaceutical product or medical supply for that matter, continues to exercise developing nations, aid agencies, etc.

Apart from the cost of APIs, labour, equipment, the lack of qualified personnel with the appropriate manufacturing experience, etc, there is also the simplistic view taken by many that this business is easy to do: "throw money at it, and see tablets come out".

In Zambia, some of us have advocated for a strong investment infrastructure that would allow private investors to invest in pharmaceutical local production. I believe across the Southern Africa Development Cooperation (SADC) community, there have been initiatives and investment strategies (eg, duties on imported raw materials for production and packaging of medicines; employment of overseas experts to manage production; preferential procurement from local manufacturers / wholesalers, etc) by member states, including those aiming to encourage local production of pharmaceutical products.

While there have been some examples of 'take off', many challenges remain, and for the time being, the best and possibly secure option is importation of finished good, as the overall costs still are affordable.

There is of course the option of encouraging regional manufactures to continue in business, by a preferential buying policy that might direct buying from these, established and hopefully highly regulated manufacturers, of which there are some in there SADC region, as an example.

Regards,
Bonnie

Bonface Fundafunda PhD., MBA., B.Pharm
Managing Director,
Medical Stores Limited
P.O. Box 30207
Mukwa Road, Plot 6446
Lusaka,
Zambia
Email: bonface.fundafunda@medstore.co.zmWeb: www.medstore.co.zm

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E-DRUG: ARV local production costs (5)
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Dear colleagues
The many EURASIAN patents filed for ARVs in these countries could be the principle reason for the premium prices that they pay for ARVs.

Where valid patents exist, manufacturing will only be possible if the patent holder agrees not to assert their patent, or the country applies TRIPS flexibilities.

It could be more cost effective to explore how to navigate the ARV patent landscape for these countries and Patent holder pricing since majority of these countries are classified as Middle Income countries.

Atieno Ojoo,
BPharm, MPH, CHSCM;
TechnicalSpecialist, Pharmaceuticals;
UNICEFSupply Division,
2150 Nordhavn, Copenhagen, Denmark.
http//www.unicef.org/supply
Email:aojoo@unicef.org