MAY 3 — Debates on how to improve healthcare in
developing countries often start from the same premise: patents can potentially
raise drug prices, so they should be abolished for better public health.
In the early 2000s this argument drove the campaign
against patents on HIV drugs in South Africa. This week it is motivating
campaigners against the Regional Comprehensive Economic Partnership in Asia — a
proposed Free Trade Agreement between 16 Asian countries that may impose new
intellectual requirements.
NGO disquiet about drug patents has even led to the
creation of a UN High Level panel on access to medicines, due to report its
recommendations in New York next month.
Such concerns may in fact be overblown. This is an
implication of an interesting new study by researchers at the University of
Ottawa and published in April by the World Intellectual Property Organization
(WIPO) in Geneva.
To better understand how patents impact access to
medicines, the researchers counted how many of the World Health Organisation’s
(WHO) List of Essential Medicines are subject to patent protection in
developing countries. This list contains 375 or so medicines considered most
important by WHO experts.
It’s a hugely influential list, and one based purely on
the clinical usefulness of a medicine, not cost or patent status. Developing
country governments and large international donors use it to guide which
medicines they will procure.
The researchers checked national patent registries in
developing countries and double-checked with manufacturers. They found that
patents for 95 per cent medicines on the list had expired.
Put simply, patents are not relevant to the vast majority
of drugs typically used by physicians in developing countries.
Most of the remaining 5 per cent of medicines — around 20
products — on the WHO list with patent protection are for HIV/AIDS. But patent
owners either don’t register or enforce their patents in the poorest countries.
For middle-income countries, manufacturers often enter into voluntary licensing
deals with generic manufacturers to broaden access, meaning there are cheap
generic copies on the international market.
The one medicine with no generic equivalent is the cancer
drug, bevacizumab (marketed as Avastin by Swiss patent-owner Roche). This
modern so-called ‘biologic’ drug is used against many cancers, and works by
starving tumours of their blood supply through blocking a key protein.
Patented or not, these biologic drugs are difficult for
generic competitors to copy cheaply.
Unlike most drugs, which are chemically synthesised and
made from just a few molecules, biologic
drugs are manufactured in living systems such as plant or animal cells, and
have complex molecular structures. Their manufacture demands significant
investment and technical know-how, meaning such drugs will never be as cheap
as, say, generic aspirin.
One implication of the study is that if patents were
abolished tomorrow it would make little difference to the cost or availability
of most medicines used in developing countries.
Even so, these medicines are frequently unavailable in
public health systems.
In 2014, researchers at the University of Utrecht in the
Netherlands found that, on average, essential medicines are available in public
sector facilities in developing countries only 40% of the time.
While generic medicines are cheap to make with no royalties
to pay, they are still too costly for most people in developing countries.
One example from the WHO list is budesonide, commonly
used by asthma sufferers. A single inhaler costs a staggering 50 days wages in
Mozambique. In the US, one inhaler costs only US$5 to US$7 (RM20 to RM27) —
around 30 minutes work on the median hourly wage.
The reasons behind the expense and scarcity of essential
medicines in developing countries are complex, but failures of governance loom
large.
Mark-ups along the distribution chain inflate the final
price of medicines and include import tariffs, sales taxes, value-added taxes
and retailers’ and wholesalers’ margins. In Kenya, mark-ups add 300 per cent to
the manufacturer’s price; in Brazil it’s 200 per cent, says IMS, the global
healthcare data provider.
Dysfunctional medicine supply chain management is another
culprit. A 2015 survey by humanitarian NGO Medecins Sans Frontières reported
one in three health facilities in South Africa have shortages of key HIV and
tuberculosis drugs. The drugs are imported in sufficient quantities but fail to
reach patients due to “local logistical and management problems, ranging from
inaccurate forecasting to storage or transport issues”, said MSF.
Governments under-invest in health too. While most
European Union countries commit 8 per cent to 11 per cent of GDP to health, few
Asian and African countries spend more than 5 per cent: not nearly enough given
their enormous health challenges.
These are the major influences on access to medicines.
Public health would be best served if the political focus were on these issues,
rather than patents.
* Philip Stevens is senior fellow at the Southeast Asia
Network for Development (SEANET) and director of Geneva Network, a research
organisation focusing on health, intellectual property and trade.
See also:
IPR and Innovation 30, Patents and pharma issues in Asia in 2007, February 07, 2016
IPR and Innovation 31, Plain packaging and trademark-busting, February 19, 2016
IPR and Innovation 32, On TPP, medicines patent and tobacco trademark, February 29, 2016
IPR and Innovation 32, On TPP, medicines patent and tobacco trademark, February 29, 2016
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