[e-drug] Quality pharmaceutical manufacturing in LDCs -possible?

E-DRUG: Quality pharmaceutical manufacturing in LDCs -possible?
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[The complete article follows. It is quite long but important. Moderator]

Cross-posted with thanks from druginfo lists.

Hi all

This Lancet story is not just about the specific example of Quality
Chemicals in Uganda, but also raises very important questions about
industrial policy. The South African MoH has recently stated strong
preference for lowest cost procurement of ARVs, discounting any
potential industrial policy or balance of payment gains that might be
achieved from preferential procurement of locally-manufactured
products.

regards
Andy Gray MSc(Pharm) FPS
* Senior Lecturer
Dept of Therapeutics and Medicines Management
* Consultant Pharmacist
Centre for the AIDS Programme of Research
in South Africa (CAPRISA)
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Tel: +27-31-2604334/4298 Fax: +27-31-2604338
email: graya1@ukzn.ac.za or andy@gray.za.net

E-DRUG: Quality pharmaceutical manufacturing in LDCs -possible? (2)
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A succinct analysis on whether Least Developed Countries (LDCs) are ripe to initiate local regulated drug manufacturing ventures.

I personally do not see sustainable local manufacturing in LDCs (especially in Sub Sahara Africa) without a vibrant research environment. Unfortunately, in most of these countries research in drug development (particularly formulations) is lacking and this can be a major hindrance to any established company (be it generic or novel).

I draw an example from Cameroon (again!), a nation of ~20 million people and considered an advanced country by its Central African neighbours which cannot boost of any pharmacy school. If such a company were to be set in this country where would it trained scientists, technicians, quality assurance personnel and pharmacists come from?

It is therefore important that applicable governments not only create medical schools but add pharmacy faculties to complement drug research and development in the fight against diseases.
In this way companies may find a more friendly environment to establish in which most of the manpower and technology will be available.

Kind regards.

Magnus A. Atemnkeng
Montreal, Canada
(magnusajong@yahoo.com)

E-DRUG: Quality pharmaceutical manufacturing in LDCs -possible? (3)
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{There are also the technical and infrastructural requirements to develop GMP - vary for different products. As Bonnie says, maybe start with what is possible and build up. Moderator]

Dear colleagues,

There is clear political interest in establishing or strengthening local pharmaceutical manufacturing sector in most developing countries. However the difficulty I see is the lack of appreciation of what it takes to set up such a venture. Other colleagues have already touched on the investments needed (human resource, finances, etc). Too often, governments are made or compel themselves to drive the initiative by financing the venture, and by implication, forcing the competition out, and forcing the consumer to buy what they are now forced to buy. By creating an enabling climate that promotes investment in private sector, the pharmaceutical industry can be allowed to grow naturally to a point where the companies can determine what to produce and which market to target. The buyers (eg, the public health sector) also needs to exercise its rights to buy from sources that will provide quality, safe and effective essential drugs, without being misdirected by external pressures.

One of the major challenges to the local manufacturer is getting financing to start- up the venture. I am not sure what it is like in other developing countries, but in my own, the commercial banks are a challenge to the local investor, creating a situation where only external investors are able to invest in this business. If that situation can be changed to benefit local manufacturers, I am sure these companies would be able to create investments into their businesses, resulting in a more effective and competitive local manufacturer base.

The work thast UNIDO and others are doing in some of the developing countries is, if I am correct, aimed at assisting governments to create the appropriate policies and infrastructures that will enable this pharmacy business to develop in a competitive environment.

I am certain that few governments would want to put their public at risk by promoting locally made goods, when there is evidence that such goods do not meet the minimum standards. The biggest challenge is to get the infrastructure (financing, expert human resources, etc) that will allow a manufacturer to operate economically and profitably.

Regards,

Bonnie
Bonface Fundafunda PhD., MBA., B.Pharm
Manager, Drug Supply Budget Line
Ministry of Health,
P.O. Box 30205,
Ndeke House,
Lusaka,
Zambia
Tel: +260 211 25 41 83
Fax: +260 211 25 33 44
Mobile: + 260 979 25 29 00
Email: bcfunda@hotmail.com

E-DRUG: Quality pharmaceutical manufacturing in LDCs -possible? (4)
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[Small countries have started with production of ORS and simple IV fluids - transport of what is basically water is expensive. Local production can save lot of money. You don't have to aim for products that need compulsory licenses at the start. Moderator]

Personally too, it is quite frustrating having to distill all the
various arguments for and against local production and to make sense
of them.

The domininant oligopoly firms stand to benefit from a lack of
diffusion of productive capacity, as price differentials before and
and after the introduction of generics (or the threat of compulsory
licenses) clearly attest.

Whatever happened to the promise that IPRs would lead to diffusion and
disemination of technologies (not just of consumption of technology
rich goods in protected markets). The rationale for IPR protection
gets lost in what amounts to a protection of investment argument (in
favour of the BigPharmaOligops) instead of a knowledge based model
(disemination, diffusion and forward and backward linkages).

I agree that there is a lack of capacity, but this is no argument for
not developing that capacity (this advise is like telling the Japanese
not to go into car manufacturing because it is too difficult and they
have no comparative advantage). Michael Porter has talked about
dynamic imperfect competition and created comparative advantage - is
it that these concepts are too sophisticated for Africa or there is
too much of an infrastructure gap? By this I do not mean to play the
race card, but really the so-called sophisticated evidence and
arguments against building African capacity (in particular and
distinct from say Asian capacity) are quite pedestrian and that is
being generous!

There are more sohpOn LDCs Carlos Correa has argued in a background
paper (UNCTAD 2006)for more nuance in addressing these issues - there
are different levels of capacity initiation, internalisation and
generation (basic formularies, more complex adaptations and then
creation of new knowledge).

And then there is the issue of scale. If one looks at the WHO mapping
of the malaria health services in Kenya, one sees a mess (with some
saying that simply managing the assistance being more costly than what
is actually delivered) with all sorts of requirements including on
procurement. It seems like the Paris Declaration on Aid Effectiveness
is only for recipients and not for donors. If there state were
strengthened, the issue of scale could be sorted so that in the medium
term capacity and a viable local market is built up. This issue of
price applies to local production, while at the same time pundits
argue that BigPharmaOligops should be allowed to charge any price they
want. Apparently price sensitivity as a variable in these arguments
applies only when talking about local production but many pundits then
get very coy when it is monopolist patent pricing flexibilities in
question.

There are a number of groups challenging this perception and there is
nothing like killing a good idea like local production and setting it
up to fail. Is the Ugandan experiment to go the same was Zimbabwe's
(not receiving support).

In food we have seen that where food aid floods the market, it can
break productive capacity of African farmers, causing longer term food
aid needs. Nice, no? Donors get to do charity and Africans can shine
their begging bowls. It took a campaign to get this sorted out - I
mean really! How many donors are going to buy from them? How many
generic producers are offering them advanced services (selling other
skills instead of just pills) like marketing, quality control, etc.

The same can happen here and then every one can say oh we tried it and
it does not work... Africa... the dark continent eh?

Perhaps it is also a matter of perception, why is it that with a tool
as powerful as monopoly right protection, Africa is not able to beef
up its productive and delivery capacity? Is it not a good deal to say
to African health workers, why go be a low level pharmaceutical
functionary in the North when you can own/run/build a factory at home?

For all the aid and good intentions, as one African, it is hard not to
come to the conclusion that consumption of high tech goods equates to
technology transfer and that the rich country PharmaOligops must be
protected whatever the cost. The situation is so desperate that even
African progressives have to laud the Doha Declaration - which gave us
rights we already had.

So I think some clarity of perspective and good values is ALSO needed
to move this debate forward and to increase African self-reliance.

Riaz Tayob
SEATINI South Africa
Riaz Tayob <riaz.tayob@gmail.com>