Julius Kiiza, 26, was like
many youths his age a few years back. He loved to hang out and live a good
life. Never in his wildest dreams did he think he was developing a virulent
form of Tuberculosis – the multi drug resistant TB (MDR-TB).
I met him at Hoima
regional referral hospital TB ward. As he motioned towards me, it was as if his
legs would snap under the weight of his body.
Kiiza, a father of
four, was diagnosed with MDR-TB on November 28, 2013. Prior to this, Kiiza was
already grappling with HIV which was discovered in 2011.
He was to later develop
a wracking cough, characterized with chest pain.
“I would lose breath
especially at night because of chest congestion,” he said.
Kiiza was diagnosed
with TB and was started on the regular eight month drug regimen. Five months
down the road Kiiza was found to have MDR-TB.
MDR-TB
occurs when bacteria do not respond to Isoniazid and Rifampicin, the two most
powerful, first-line anti-TB drugs.
Because of Kiiza’s co-infection (HIV and TB), he swallows
at least 20 pills a day and he will be receiving an anti TB injection daily for
six months.
While identifying those with the active disease will
provide a long-term public health benefit, Moses Mulumba, a patent lawyer says
that without new, simple and affordable treatments for MDR-TB, this is impossible.
“If pharmaceuticals developed one tablet a day for
TB, this would mean reduced pill burden and greater adherence. However, such
developments for the developing world are deficient due to the lack of return
on investment opportunities for pharmaceutical companies,” says Mulumba, the
executive director of Center for Health, Human Rights and Development (CEHURD).
Most recently, Britain/Sweden pharmaceutical,
AstraZeneca announced it was pulling out of all early stages of research and
development for malaria, TB and neglected tropical diseases to instead focus on
cancer, diabetes and hypertension.
Welcome to the world of intellectual property (IP),
where giant pharmaceuticals determine drug availability and pricing.
Prices of drugs vary depending on whether the drug
is under patent – 20-year protection by the manufacturer – or generic, where
the patent has expired.
In the private sector market, the brand/patented version
of Linezolid, an MDR-TB treatment drug, costs $65 (approximately Shs 166,400) for
a daily pill. For a patient taking a pill a day for two years, this amounts to over
$49,000 (over 125m). It is produced by Pfizer, an American pharmaceutical corporation.
Generic versions of the drug, produced by Hetero,
an Indian pharmaceutical company, cost of $8 (Shs 20,000) per pill.
When asked whether he would have afforded
Linezolid had it not been provided freely, Kiiza laughed sarcastically: “I
think I would have died a long time ago because I don’t have a cent!”
Because majority of Ugandans still survive on less
than $1 (Shs 2,560) a day, Uganda receives TB drugs through aid.
The case of ARVs provides a dramatic illustration
of the global impact of Indian drug firms.
In 2001, Indian drug company Cipla, introduced
first line treatment for HIV at $ 350 (Shs 896,000) per person per year, a
stunning offer at the time.
Other Indian firms followed Cipla’s model and
today, 80 per cent of people living with HIV who are on treatment in developing
countries rely on Indian generic drugs.
TRADING
AWAY LIVES
Uganda being a member of the World Trade
Organization (WTO) is under obligation to develop rules that comply with WTO
guidelines. Among these is the Trade Related Aspects of Intellectual Property
(TRIPS) agreement requiring all members to standardize minimum standards of IP,
including patents for pharmaceuticals.
IP rights give the
creator an exclusive right over the use of his or her creations for a certain
period of time, such as 20 years, for a scientific innovation like medicine.
The pharmaceutical industry in developed countries strongly depends on
the patent system in order to recoup research and development costs.
“TRIPS sustain a regime of private monopoly rights
which impedes access to essential medicines because of prohibitive prices. It also
delays production and market entry of generics because producers will have to
wait 20 years for a patent to expire,” Mulumba explains.
Moreover, countries such as India
and Brazil where
generics are produced now grant medicines patents in order to comply with their
obligations as WTO members. New drugs are already patented in these countries
meaning that production of
affordable generics is now restricted.
Such a
restriction led Cipla to establish Quality Chemicals Limited in Uganda because
that law does not hold for LDCs.
Under
TRIPS, LDCs are supposed to enforce patents
on all medicines by 2021. Tentatively, this means the end of all generic drugs.
In
response to the TRIPS agreement, WTO delegates issued the Doha declaration on
November 14, 2001 which exempts LDCs from implementing patent law for
pharmaceuticals until January 1, 2016. This was extended to 2021 last year.
ENFORCING PATENTS IN
UGANDA
To
guarantee intellectual property rights to innovators, parliament this year
passed the Industrial Properties Act. It spells out protection for products and
processes in all fields of technology, including medicine.
Mulumba
forecasts that the law will only work if there is government commitment to
invest in research and development, develop human capacity and offer attractive
incentives such as tax holidays to innovators.
“The law integrates flexibilities such as the
bolar provision which enables researchers’ reverse-engineer drugs even when the
patent on it has not yet expired. But all the seven plants we have are not
doing research because of high production costs,” he says.
Another policy is the Anti-Counterfeit Goods law which prohibits the
manufacture, trade and release of fake goods on to the market. Contentious, however, is the fact that it
regards generics as counterfeits.
“This is
part of a global agenda to keep developing countries from importing from third parties
like India and Brazil where the cost of production is much cheaper. All these
things are happening because we are a disorganized lot. We Africans are doomed
unless we wake up!” says Edgar Tabaro, a patent lawyer with Karuhanga, Tabaro
and Associates.
SOLUTIONS TO A GLOBAL CRISIS
In
2000, the UN Security Council declared HIV a global security issue and resolved
to establish a Global Fund (GF). GF is the biggest financer for HIV and TB
programmes in Uganda, having channeled at least $ 200m over the years.
“In
October, Uganda is sending the GF another proposal for HIV/TB funding to enable
us scale up prevention and treatment efforts,” Prof Vinand Nantulya, chairman
Uganda Aids Commission said.
Uganda
is also a member of WHO’s Global
Drug Facility (GDF), the largest supplier of quality TB treatments. Nantulya
says it is through this that the country procures TB medicines and innovative
tools such as the GeneXpert at reduced prices.
“Uganda needs to develop collaborative research so
that our scientists can catch up with others in the developed world and
partnerships such as the Global Alliance for TB drug development should be more
actively supported to allow for the development of drugs that are free of
patent restriction,” Tabaro urges.
Currently, 11 TB vaccines are in clinical trials
worldwide. WHO estimates that the earliest a vaccine could be licensed is 2020.
BCG (Bacille Calmette Guerin) vaccine remains the only vaccine against TB in
general use.
This
story was supported by the African Center for Media Excellence.