Nazeem
Mohamed is chief executive officer of Kampala Pharmaceutical Industries (KPI),
a Ugandan generic manufacturer. Local manufacture of medicines is described by
many, including the World Health Organization, as one of the tools that will
increase access to medicines. Mohamed is former vice-president of strategic
product development at Novo Nordisk, based in Belgium. He also worked for
several leading multinational companies such as Pfizer and GlaxoSmithKline
before his appointment as CEO of KPI.
With Intellectual Property
Watch’s
Catherine Saez, Mohamed discussed KPI, the challenges of local drug production,
the burden of non-communicable diseases, the issue of substandard medicines,
rules engineered in the West which can hinder affordability and access in a
least-developed country, unfair competition, and unmet skills building needs.
Intellectual
Property Watch (IPW): Please
tell us about Kampala Pharmaceutical Industries and what you produce?
Nazeem
Mohamed (NM): KPI is part of the Aga
Khan Development Network, a group of private, non-denominational, international
development agencies that work in the fields of social, cultural and economic
development. The social and cultural development activities, such as education,
health, school, training for farmers is all done not-for-profit. However, Aga
Khan Fund for Economic Development runs companies for profit and has a strong
presence in particular in East Africa, West Africa, Pakistan and Central Asia.
KPI is part of the Aga Khan Fund for Economic Development, and is a for-profit
company.
The
Aga Khan group bought KPI in 1996 at that time as a joint venture with an
Indian company called Kopran, which at that time was one of the top ten generic
manufacturers in India. A few years later, we bought out Kopran which is now a
fully owned company of the Aga Khan Development Network.
We
manufacture and market branded generics, about 60 products ranging from pain
killers to both penicillin and non penicillin antibiotics, cough and cold
syrups, allergy products and creams and ointments, products that we really need
in our region. They are all generics but branded generics and part of the
essential products lists.
We
employ about 280 people and are the largest manufacturer in terms of volume in
Uganda and one of the largest in East Africa. We also export to Tanzania,
Kenya, South Sudan, to Rwanda so KPI is not just a Ugandan company but an East
Africa regional company.
IPW: Uganda is a
least-developed country (LDC). Are you producing generic versions of medicines
under patent?
NM: No, we have not had
any need to produce generics of patented products. For many of our countries
the TRIPS [the World Trade Organisation Agreement on Trade-Related Aspects of
Intellectual Property Rights] regulations have not fully integrated into our
laws, although the process is going on. Luckily, to date we have not had any
emergencies which would have called for the need to use drugs under patents. In
the region, we are already making second-line antiretroviral drugs and the
anti-malaria drugs that we need.
But
of course, the TRIPS flexibilities give us an advantage, in particular in
Uganda which is an LDC. If we had an emergency, we would be able to basically
avoid patents and manufacture those products. So it is kind of an insurance
clause.
IPW: What is the
procedure for producing generic medicines?
NM: The way we produce
medicine is really no different from the way GlaxoSmithKline or Roche or
anybody else does. We follow very strict formulae, either the British, European
or international pharmacopeia. In Uganda we are lucky – it is not the case
everywhere – we have a very capable and well respected National Drug Authority
(NDA). They are very strict … and keep us improving our quality systems.
IPW: We often hear that
LDCs do not have production capabilities. Would you agree with this?
We
make drugs the same way that top multinational companies do. The only
difference is that our facilities and some of the documentation may not be as
smart. Those things cost an enormous amount of money. One of the challenges,
and I have discussed this many times with organisations in the West, if you aim
for the absolute highest quality in terms of the way the product is made, it
comes at a tremendous cost and this would mean that our products would be
unaffordable for our people.
Today,
we sell 100 amoxicillin capsules for less than £1 [US$1.70]. This is where one
of our challenges stands. There is a tremendous move by international
organisations like the WHO [World Health Organization] in Geneva to push us to
improve our quality systems. That is fine and that’s good, and we want to do
it, but to try and push us to comply to the WHO expectations of current good
manufacturing practice, is virtually impossible for most of us.
Today
in Africa, there are only a few companies that have achieved this standard but
unfortunately they are not able to produce the basic essential medicines that
we need because of their very high cost of operations, making the price of the
finished medicine unaffordable for most of our population.
The
quality requirements are very rigid. For example, if you were setting a new
facility, following those good manufacturing practices, every room in your
factory, has to be controlled for temperature, humidity and the number of times
the air changes. To reach this standard requires millions of dollars, just for that
system. For most of us it is just not affordable. We have a good quality
system, but not to that standard.
“The
way we make products is not exactly the same as a multinational company. If we
were to do that we could never sell the products at the price that we do.” –
Nazeem Mohamed
If
you take any of my finished products, or from any local manufacturers here in
Uganda and test it against international standards, they will all pass. In
fact, before any KPI product is released to the market it must pass the
international standard according to the pharmacopeia. But the way we make
products is not exactly the same as a multinational company. If we were to do
that we could never sell the products at the price that we do.
We
are continually improving our quality standards, but between quality and price
there is a balance.
IPW: Is research and
development being conducted in Uganda for endemic sicknesses?
NM: Yes, there is a fair
amount of research done on malaria, HIV/AIDS, and clinical trials conducted,
but no real development in terms of drugs, that is all done in the West and now
increasingly in India and China.
IPW: What is the burden
of noncommunicable disease in Uganda and what is the need for medicines?
NM: It is one of our
biggest challenges going forward. Today governments are struggling to even
manage the infectious diseases. Now people in Africa, particularly the growing
middle classes are beginning to develop life-style diseases, such as heart
diseases, cancers, diabetes, and high blood pressure. Those are incredibly
expensive to manage because once you get them, you get them for life.
How
are we going to afford it? It is a big burden. The only way to address it is to
really work in a partnership with the government, private sector, and civil
society. There is a lot of education to be done on the prevention of these
chronic diseases.
IPW: In what areas would
you say that Uganda is most in need of affordable medicines?
NM: Many medicines are
still not quite affordable in Uganda. Half our population lives on less than
two US dollars a day, so how can they afford medicines? It is a huge problem,
in particular for NCDs. To be honest, if you got cancer, you are talking about
thousands of dollars of treatment. Very, very few people in Uganda or in our
region can afford that.
“For
AIDS and malaria, drugs are affordable because there is still a lot of donor
funding coming in, but as soon as the subsidies go, it is going to be
difficult.” – Nazeem Mohamed
For
AIDS and malaria, drugs are affordable because there is still a lot of donor
funding coming in, but as soon as the subsidies go, it is going to be
difficult. We make fairly affordable drugs but a large proportion of the
population just does not have the means to buy drugs.
Access
is a very complex problem. Almost 90 percent of the population lives way away
from cities. It is not unusual for people to walk for a day to get to a clinic.
It is interesting to note that even in any tiny village you can always find
Coca Cola and cigarettes. So maybe we can learn something from that.
Some
products require a cold chain to be transported and that just does not exist.
But we are not allowed to transport our tablets with other goods than
medicines. There are a lot of restrictions and some of them make sense but with
tablets we don’t need to be that careful. There is no reason why we could not
transport our medicines in Coca Cola trucks. Some rules are made in the West
and it is very difficult to change them because of reliance on donors that
apply those rules.
IPW: Counterfeit or
spurious medicines are supposedly a huge problem in Africa. How is that problem
affecting your work and markets? How are you addressing it as a generics
company?
NM: A very real issue but
I have not seen any real substantiated data. We are led to believe it is a very
big problem but I cannot quantify the problem and I don’t know if anybody else
can. KPI belongs to the association of local manufacturers and one of the
association’s goals is to pick up substandard medicines from the pharmacies and
report them to our regulatory agency.
Sometime
back a pain killer manufactured in China was sold on the market for a price
which was the same as what we have to pay for the raw material. We asked for a
sample and analysed it and it was clear that the product failed. This was
reported to our regulatory authority and I think they instituted a recall but
by the time the recall is implemented, the drug is already sold.
There
is a lack of capacity in our regulatory authorities to go after these guys.
Those are bad guys and we want to go after them, but I have never seen any data
and would love to see some.
I
am not saying that all generics are good, as there are a lot of substandard
generic drugs. However, at least in East Africa, the substandard products are
not manufactured locally, they are imported, primarily coming from India and
China.
IPW: What is your
relationship with the brand-name foreign pharmaceutical industry?
NM: We don’t have much of
a relationship with brand-name foreign pharmaceutical industry. Until recently
those companies were not so interested in Africa. The continent represented a
very small part of their earnings. In the last few years because it has become
so difficult in the West, in part because of regulations and margins going
down, everybody has become interested in Africa.
But
multinationals are not particularly investing in Africa. There is a lot of talk
going on, but if you look at technology transfer, for example, there is very
little being done by Western companies. The Indian companies have been more
aggressive in taking a position in Africa.
We
have a lot of other needs, not money, but to develop our skills, for equipment.
Back when I was working for those multinational companies, they would change
their laboratory and production equipment very often. Three-year-old equipment
for us is nearly new. If somebody was brave enough to start an initiative and
make sure that those older equipments from the West can be sold or donated to
companies in Africa, it would be a very smart thing to do. That could maybe
done by an NGO.
IPW: Is there anything
that you would like to see from a policy standpoint, either nationally,
regionally or internationally that would be helpful for you?
NM: One of the biggest
issues in our region is unfair competition. About 80 percent of the products in
Eastern Africa are imported from outside, primarily from India and China, but
also Europe, Malaysia and other countries.
India
and Chinese governments give subsidies to their manufacturers. They can
actually dump products in East Africa at an artificially low price making it
very difficult for local manufacturers to compete. It is not a level playing
field. Some countries are smarter, such as Ghana and Nigeria. They have done
certain things in terms of government policy to support their local industry. For
example, in Ghana you cannot import certain products and there is a price
preference for locally manufactured products in government tenders,
consequently, their local industry is far stronger than in Uganda. Ghana in
terms of population is smaller than Uganda but they has 22 companies actually
manufacturing medicines, supplying around 30 percent of their products whereas
in Uganda we have around 6 factories and we supply only around 10 percent .
Other
policy issues include higher education. We have very smart people coming out of
our universities but they are extremely academic in their approach. They have
very little technical experience. We need to improve the university curriculum
to include a larger content of industrial training.
Not
enough is going on in research and development and it would be useful to start
some hubs and start developing new products, in public private partnership.
IPW: What would foster
drug innovation in Uganda?
NM: The first thing would
be to reform our curriculum. Students need to get excited about working in
industry. We also need skills in maintenance. At the moment for the equipment
we have, we often fly people over from India to do the maintenance. It is just
not taught in our schools and universities. This part has to come from our
government.
We
also need a lot of support from outside initially so that we are able to run
out our facilities more efficiently. Although we are making drugs we do not
have a huge amount of experience. So that needs to be done.
Also
sometime people do not appreciate that when donors are just dumping drugs this
is not helping us. I would much rather donors send an experienced formulation
development person from the West to come to Kampala for two months and stay
with my team and teach my team how to approach formulation development because
that is not taught here.
IPW: Thank you.
