Transcript Past, current and future production capacity of generic medicines in

Past, current and future production
capacity of generic medicines in
Lesotho
By Gertrude Mothibe, Lecturer in
Pharmaceutical Sciences, and
Pharmaceutical Chemistry, NUL
DEMOGRAPHY
• Lesotho is a landlocked country within the
Republic of South Africa, with a population of
1.8million;
• Economically classified as Least Developed
Country (LDC);
• It is a member of the SADC states and a
member of SACU;
• This immediately influences business practices
in Lesotho, including drug manufacture.
PAST ….
• In 1977 Lesotho took the decision to protect
its citizens against drug shortage in the event
that the then South Africa should close its
borders with Lesotho.
• The decision to have a “National Drug
Stockpile Organization (NDSO)” was a direct
response to this observed threat.
• Along with that decision, was the decision to
manufacture drugs within the country.
LDA, LPC
• This gave birth to the Lesotho Dispensary
Association (LDA).
• In 1987 the NDSO’s purpose was revisited and
translated from a stockpile organization to a
“service” organization, thus keeping its acronym
of NDSO.
• The dispensary association’s purpose was
radically changed from being a non-profit drug
manufacturing company to a business
corporation called Lesotho Pharmaceutical
Corporation (LPC).
Markets
• Back in 1987 the drive for GMP certification was
lacking and this gave the newly established LPC
both its glory and its downfall.
• The corporation enjoyed markets within the
SADC region and as far north as Eritrea and
Somalia.
• Interesting markets were those of the South
African “Bantustans” whose drug purchases were
not regulated from Pretoria! They brought
healthy business to LDA/LPC.
Glory..
• The major local client NDSO was managed by
LDA/LPC.
• Those were the glory days.
• However ….
• The “chink in the armour” - this did not put
pressure on LDA and its successor LPC to get a
GMP certificate.
Products
• The products were good. Recipient countries
tested them, were satisfied with the quality, and
kept their loyalty.
• Clients loved in particular the anti-TB drugs
(Ethambutol, Isoniazid, Pyrazinamide, Rifampicin,
in single compounds and combinations).
• Even the South African patients from the nonBantustan areas accessed these, following the
regulation that a patient could obtain and import
small amounts of drugs as per prescription.
Changes in SA
• 1990 the regional scenario changed when –
VIVA!! Nelson Mandela was released from prison.
• While the region celebrated the prospect of good
economy, LPC WAS NOT READY!
• Efforts to upgrade the plant to GMP status proved
very expensive. Partnerships were tried but no
efforts bore fruits. Sale of the company was tried
but no successful negotiations between potential
buyers and the government were realised.
Delinkage
• Within Lesotho, at the end of 1999 NDSO was
delinked from LPC.
• This instant market now required that LPC
participates in tenders and fight for sale of its
lines at competitive prices
• As part of the delinkage, LPC was accorded a
15% local preference. However, even this was
not enough to protect the company against
multinationals from India.
GMP upgrade needed
• At the time of NDSO de-linkage TRIPS
flexibilities were in place, if only LPC was GMP
compliant!
• The many factors working against LPC left it in
serious financial difficulty.
• May 2003 the government granted LPC M8
million (approximately $800,000) for the GMP
upgrade of the facility.
Financial issues
• Unfortunately the calculations made gave too
low a figure for any significant change, and the
result was still a non-GMP compliant LPC.
• Further requests to government to bail out
the company with a grant for operational
purposes were not entertained.
• In 2007 the government took the decision to
close the company. A sad ending, however ….
OPPORTUNITIES
• Before we get to the present ….
• OPPORTUNITIES brought about by the LPC
crisis ….
• This was now opportunity for potential
manufacturers to start something that would
be built on current Good Manufacturing
Practices.
Opportunities
• Lesotho has opportunities like straight out of the book:
• Being an LDC, it is exempted from TRIPS (albeit until
2021);
• It has a relatively stable political and labour set up;
• Literacy rate is 83%;
• It has easy access to foreign exchange for purchase of
APIs;
• Business taxation is more attractive than most
countries;
SADC, SACU
• The country is a member of SADC and SACU;
• As a member of SACU, the country enjoys both
SACU benefits as well as LDC exemptions;
• South African harbours are within reasonable
reach (Durban being 6 hours drive from the
capital);
• International organizations still play a big part, in
particular procurement agencies like Global Fund;
Epidemics
• HIV prevalence is at 23.6% - the second highest in
the world (as per July 2014 statistics), a crisis for
the country, and opportunity for industry;
• (CAUTION: the 20 products that Lesotho must
send letters to ARIPO answering on their patent
issues are to do with HIV! Those letters must be
answered right now!)
• TB statistics place Lesotho fourth in the world;
• Pharmaceutical Technologists and Pharmacists
are trained in-country.
• With these opportunities, how has Lesotho
positioned itself to take advantage of them?
• CURRENT STATUS:
• Unfortunately, these opportunities have not
been tapped effectively.
• Companies that manufactured cosmetics took
opportunity of the gap created by the absence
of the popular LDA Hand & Body cream once
manufactured by LPC.
Other manufacturers in Lesotho
• One company, Tripharm Agencies, which had
been set up as a Wholesaler in the late 80’s,
had started cosmetic manufacture before LPC
was closed.
• It now has expanded into drug manufacture,
although still very small scale, manufacturing
medicated creams.
Post LPC
• The LPC itself was sold to a Chinese
consortium which, up to August 2014, has not
started to manufacture drugs.
• A few private companies buy finished
products and sell to NDSO and community
pharmacies, accessing the procurement
preference for local companies. Their
challenges were discussed at the 1 day
workshop on 12 June 2014.
Concoctions?
• A new manufacturing trend has appeared on the
scene – concoctions of drugs that are sold on the
streets in large quantities.
• These concoctions seem (and claim) to be plant
based and are sold for almost all kinds of
diseases. Their quality is completely unknown.
• With this poor picture of current status, related
issues that impact strongly on the observed
status ….
Legislation and Regulatory Status
• For the drug industry to operate it needs an
enabling legislative environment.
• Unfortunately Lesotho started late to address
this issue.
• The Bill that will set up the Drug Regulatory
Authority has yet to be passed by parliament.
Pharmaceutical testing
• In 2011, the Pharmacy Department at the
National University started testing cosmetics
manufactured in the country and drugs
imported.
• This is still at a small scale but has the impact
that companies selling drugs into Lesotho
have to be extra careful of the quality of their
products.
Personnel
• The country has been training Pharmacy
Technologists at the National Health Training
College, since 1988. It trains Pharmacists at
the National University of Lesotho, since 2003.
This has boosted personnel availability.
• This has been enhanced by the resuscitation
of the Pharmaceutical Society of Lesotho (PSL)
as the advocacy body for pharmacists.
Finance to Support Drug Manufacturing
• With the scenario painted thus far, small
pharmaceutical companies should now be
manufacturing drugs in Lesotho. However,
start-up capital is probably the biggest
stumbling block frustrating a few companies
now.
• Thus the question remains – how do small
start-up companies access financing?
FUTURE PRODUCTION CAPACITY
• TO MANUFACTURE LOCALLY OR NOT TO
MANUFACTURE – THAT IS THE QUESTION!
• The other question that is always asked when
local manufacturing is considered is – to
import finished products or manufacture
locally.
• Arguments are always put forward for both
sides.
Dilemma
• On this issue, two opposing priorities come into
collision:
• Government must increase access of drugs for its
citizens – low prices, readily available, with the
right quality and quantity.
• Manufacturers need to get return on their
investment. Thus they will be driven to
manufacture drugs that are needed in large
quantities.
Dilemma (2)
• Government must provide drugs even for the
few patients with the odd disease, still at as
low a price as they can access.
• Manufacturers need the numbers, thus need
cross-border agreements in order to reach as
many people in the region as possible.
• But it is government that must negotiate for
cross-border agreements.
Dilemma (3)
• At the same time, government needs the foreign
exchange that exports bring, the more the exports, the
higher the foreign exchange.
• To answer the question – to manufacture or not to
manufacture locally – the two parties have to come to
the table and bring the best of both sides for the
overall health and economic benefit of the citizens of
country.
• This would also answer the issue of financing. With
government ‘support’ not ownership, companies can
approach financing houses for business loans.
Future
• At the end of the day, in Lesotho, the thought
that brought about the setting up of LDA and
NDSO still has merit.
• Locally produced pharmaceuticals are easier
to control for quality and supply.
• The skills imparted from one generation of
professionals to the next contribute massively
to the overall economic independence.
Regional approach
• To overcome the challenge of economies of
scale – companies in the region can
collaborate in terms of segmenting the
categories or groups of drugs to manufacture.
• Using the approach of regional collaboration,
local manufacture becomes an opportunity
and not a challenge.
Way Forward - Regional Cooperation
• Key goals for cooperation:
• GMP compliance and WHO prequalification
• Any drug manufacturing company must start
with the vision to be GMP compliant. This is
not an option but has to be done.
• After some years of business, with the right
partners, the company may explore WHO
prequalification on one or more of its lines.
Regional examples
• Examples:
• Universal Corporation in Kenya
• Varichem in Zimbabwe.
Training of personnel
• The Southern African Generic Medicines
Association (SAGMA) is already in the process
of organizing training sessions for its members
in partnership with donors, mainly UNIDO.
Regulatory framework
• Political will – this needs to translate to action
by passing all the necessary outstanding Bills
in parliament.
• In addition, mutual recognition of registration
requirements, in the SADC region at least, will
go a long way to lower costs of registration.
Already the process of Harmonisation of drug
registration for SADC countries is at an
advanced stage.
TRIPS flexibilities
• In order to be relevant to the patients,
manufacturing companies will need to look at
some of the new molecules that are needed
to attend to diseases in the region.
• While Lesotho is still a Least Developed
Country, companies can then take advantage
of the TRIPS flexibilities and access these
products.
Capacity
• Is there capacity in Lesotho for drug manufacture?
• The answer lies in the perception as to what capacity is
needed.
• FOR AS LONG AS THERE IS THE CAPACITY TO KNOW
WHAT HAS TO BE DONE – THE REST FALLS INTO PLACE.
• So, YES, there is capacity to manufacture, and to start
before 2021!
Push
• In conclusion then, manufacture of drugs in
Lesotho is feasible; is needed to continually
increase capacity, foreign income, increase in
employment, resulting in snowball economic
benefit.
• All that is necessary is realization that …
• Concerned groups only have to push: “pressurize
until something happens”.
THANK YOU!
• Written for SARPAM/LESOTHO MINISTRY OF
HEALTH Workshop on TRIPS Flexibilities
• By: Gertrude Mothibe, [email protected]
• Lecturer in Pharmaceutical Sciences and
Pharmaceutical Chemistry at the National
University of Lesotho.
• Maseru, August 2014