FIP Congress 2005
|
Problems of access to medicine are not confined
to developing countries. Under the general title “The right
medicine to the right person — can we guarantee it anywhere
in the world?”, the five symposia of the congress’s
pharmacy practice programme examined the problems associated with
the production, supply, distribution and control of the quality
of medicines. Pamela Mason and Graeme Smith report
|
 The World
Congress of Pharmacy and Pharmaceutical Sciences was
organised by the International
Pharmaceutical Federation in association with the Syndicate
of Pharmacists of the Arab Republic of Egypt.
It took place in
Cairo from September 2 to 8, 2005 |
Medicines prices rising more rapidly than those of other goods worldwide
Prices of medicines are variable and rising more rapidly worldwide than
prices of other goods. Often unaffordable for large numbers of the
population, particularly in developing countries, drugs also account
for a significant proportion of government budgets, said Margaret Ewen,
of Health Action International Europe, the Netherlands, who was speaking
on the price of medicines on 5 September.
She added that little is known about the prices people actually pay and
how these prices are determined from the manufacturers’ selling
prices. This lack of data led Health Action International (HAI) and the
World Health Organization (WHO) to develop a method for collecting and
analysing component costs of medicines, she said. This method, she explained,
involves systematic sampling of medicines outlets in at least four areas
of a country including a minimum of 10 pharmacies per area. Prices of
30 pre-selected commonly used medicines, including the “innovator
brand” and the lowest priced generic, are sampled and
all components of the price from the manufacturer to the patient identified.
So far, 42 surveys have been conducted in 37 countries. Results show
large price variations for the same medicine both within and between
brands and generics in the same country and also between countries. Highlighting
the example of ciprofloxacin 500mg tablets supplied from private pharmacies,
she said that, in Fiji, the price of the innovator brand was 20 times
as high as the lowest cost generic. In Kuwait, however, this difference
was marginal but the costs of both the generic and the innovator brand
were higher than the cost of the innovator brand in Fiji. Similar differences
were identified for other medicines, she said. These included amoxicillin
and captopril.
Ms Ewen told conference participants that such differences exist mainly
because of variations in the so-called “add-on” component
costs rather than variations in the manufacturer’s selling price.
Add-on costs include customs’ fees, importer’s mark-up, retail
mark-up, wholesaler mark-up, import tax and value added tax, all of which
can vary from country to country for one medicine. “Governments
in some countries are taxing the sick by applying high import taxes and
adding VAT,” she said. Pharmacy mark-ups vary too. In one African
country, the survey showed that pharmacy mark-up ranged from 15 to 55
per cent. Since most “add-ons” are applied as percentages,
the higher the manufacturer’s price, the higher the price to the
patient.
The challenge of buying medicines in Africa
Kwesi Eghan, from Management Sciences for Health, Ghana, discussed
the challenge of financing personal medicines in African countries.
In Africa, he said, all health and social services were government-funded
in the years following independence. However, this proved to
be unsustainable and, by the 1980s, post-independent welfare states
were in economic crisis.
Today, he explained, funding for African health care is provided
through a multiplicity of sectors, many informal. Health insurance
has been considered but rural populations are thought to lack adequate
wages for insurance. However, some insurance schemes have proved
to be successful with an increase in the use of essential medicines
in many African communities. In his opinion, the way forward is
through a combination of government funding and social insurance. “Government
cannot abdicate its responsibility for health and small health insurance
schemes, though successful, are not sustainable. Combining the best
of both is therefore the best approach,” he said.
“Health care should be supported by government but not government
run, and should be district-based with national coverage. Essential
medicines listed on an approved list together with medical care
for a majority of conditions should be fully covered — with co-payments
for enhanced services and products. Such a model would be community-owned
and small enough to be efficient while large enough to possess
economies of scale, resulting in guaranteed access for all, including essential
personal medicines,” he concluded. |
Problem
This poses a problem for patients, she said, particularly when a generic
equivalent is not available or the medicine is patented and faces no
competition. Where generic substitution is not permitted or the brand
is sold to increase profits, this, too, can make medicines unaffordable
for poorer patients. She went on to give examples of the difficulties
faced by patients from various countries. In Kenya, the lowest paid
government employee has to work 20 days to pay for a month’s
course of the original brand of ranitidine for ulcer treatment compared
with seven days for the generic, she said. For the same treatment in
the Philippines it takes 13 days to pay for the originator brand and
seven days for the generic. In Peru, equivalent figures are eight days
for the brand and two days for the generic. In many countries, neither
the innovator brand nor the generic is affordable, she added.
Ms Ewen said that the survey had identified many examples where the
availability of expensive brands is high while the availability of
cheaper generics
is low. In the Cameroon, for example, there is no generic ciprofloxacin,
while in the Philippines, there is no generic ciprofloxacin or generic
beclometasone inhaler. In many countries, although medicines may be free
in the public sector, availability is extremely low.
Affordability could be improved by increased availability of generics
in both the public and private sectors, she said. In particular, governments
could facilitate rapid penetration of generics when patents are about
to expire. Prices could also be reduced by a number of other methods,
such as removing taxes from essential medicines, and establishing price
regulation and fixed fees. In addition, doctors and consumers should
be educated on the acceptability of generics. It is also important to
have a generic substitution policy and prescribe by the international
non-proprietary name (INN), she said.
Ms Ewen highlighted the need for pharmacists, too, to act responsibly.
Although pharmacists need to make a living, excessive margins contribute
to reduced access to medicines for the patient. “Pharmacists should
consider whether they are primarily in business or offering a professional
service. It is important to find a good balance,” she concluded.
Further details about the HAI/WHO
survey
Are patents a barrier to availability of medicines?
Ellen t’Hoen, of the Access to Essential Medicines Campaign, Médecins
Sans Frontières, France, told the congress on 5 September that
prohibitive drug prices are often the result of strong intellectual property
protection. Speaking at a session on the price of medicines, she said
that patents have a significant effect on both the price and availability
of medicines, particularly for newer drugs, she said.
Recent attention has focused on anti-retroviral therapy (ART) for which
the cost until a few years ago was prohibitive for developing countries,
said Ms t’Hoen. Various goals for AIDS treatment have been set,
including the halting of the spread of HIV/AIDS by 2015 and universal
access to treatment for all by 2010. However, to fulfil these commitments,
global action is needed to ensure the affordability and the availability
of the medicines needed, she said.
She said that the Médecins Sans Frontières Access to Medicines
Campaign had produced a pricing
guide to ART.
Factors which improve the ability to offer ART include the availability
of generics and fixed dose combinations. “However,
generic does not necessarily mean low price because generic manufacturers
do not like low prices any more than manufacturers of brands,” she
said.
She then went on discuss the 1995 World Trade Organization (WTO) Trade
Related Aspects of Intellectual Property Rights Agreement (TRIPS). This
sets out minimum standards for the protection of intellectual property,
including patents on pharmaceuticals, she said. However, these standards
have been set by wealthy Western nations and are not necessarily appropriate
for developing countries. In addition, no difference is made between
lifesaving medicines and trivial goods and no difference is made between
countries.
Making reference to the Doha agreement of 2001, she said that this agreement
affirmed that TRIPS can and should be implemented in a manner supportive
of WTO members to protect public health and “in particular to promote
access to medicines for all”. The Doha agreement also clarifies
various provisions of TRIPS, she said. In particular, each member country
has the right to grant compulsory licences and also has the freedom to
determine the grounds on which such licences are granted. The green light
is also given for parallel imports and the least developed countries
have until 2016 to introduce product patent protection on medicines.
Ms t’Hoen then asked whether voluntary differential pricing could
be part of the answer to unaffordable costs for some countries. “Unfortunately,
various problems exist with this type of pricing,” she said. First,
announced prices are not always available. Secondly, single source products
are still very expensive. Thirdly, many offers are not valid in middle
income countries, so the policy does not cover the needs of all countries.
Fourthly, voluntary differential pricing does not provide access to the
recommended formulations (eg, fixed dose combinations).
Concluding, Ms t’Hoen said that without generic competition differential
pricing will not cover needs. “Competition and a wider range of
generic sources should be encouraged, and a more flexible approach brought
to the patent barrier.”
An industrial perspective
Eric Noehrenberg |
Eric Noehrenberg, of the International Federation of Pharmaceutical
Manufacturers Associations, Switzerland, gave an industrial perspective
on the differential
pricing of medicines. He began by emphasising that the TRIPS agreement
states that WTO members must protect intellectual property rights (IPRs).
TRIPS provides for strong measures against counterfeiting and allows
for compulsory licensing only as an exceptional measure.
In his opinion there are several myths about IPRs and access to medicines:
first, patents block access and generics are cheaper; second, local production
of generics will improve access; third, compulsory licensing and parallel
trade are the answers to access; and, fourth, the WTO TRIPS agreement
is blocking access to medicines.
The reality, he argued, is that patents are irrelevant for access to
essential drugs. Around 95 per cent of drugs on the WHO model essential
drugs list are not patented anywhere, yet over one third of the world’s
population do not have access to them. Antiretrovirals are largely unpatented
throughout sub-Saharan Africa (apart from South Africa).
He continued by saying that UN/WHO/ MSF data demonstrate that generic
antiretrovirals are not necessarily cheaper than brands. A UN/WHO/MSF
survey found that reported prices of multinational companies for protease
inhibitors and nucleoside reverse transcriptase inhibitors were lower
than anyone else’s, he said.
Turning his attention to South America, he said that in Argentina, where
patent protection is weak and generics make up more than 60 per cent
of the market, branded generics are sold at the same or higher prices
than originator brands. However, bioequivalence tests are seldom conducted.
He said that in June 2003, Andean countries rejected price offers of
multinational producers of ART on promises of generic producers from
India to supply their markets. “Press releases claimed that 150,000
people would soon be on triple ARV treatment. However, only 140 people
in the region got more generics in this deal. Poor countries hold little
interest for generic manufacturers,” he said. “Ecuador has
now returned to multinational companies to supply ART.”
He went on to claim that drug companies are expanding access to ART via
international partnerships and individual programmes at cost, below cost
and even for free. “The multinationals’ accelerating access
initiative is bringing top quality antiretroviral triple therapy to 127,000
patients in central and south America. Multinational company’s
products provide for sustainable supplies and known high quality standards,” he
said.
The real barriers to access are lack of adequate funding in countries
and insufficient health infrastructure, lack of financial aid and other
resources to poor countries and political policies in some countries,
said Dr Noehrenberg. “Weakening TRIPS will do nothing to address
these issues, but will hurt badly needed innovation. The WHO/HAI study
shows the real causes of high consumer prices — tariffs, customs
fees, insurance, import taxes, mark-ups of importers, wholesalers and
retailers and VAT. The WTO should focus on the tariffs and taxes that
restrict access and distort trade.”
Dr Noehrenberg went on to discuss the Doha clarification of TRIPS, particularly
the green light given to parallel trade and compulsory licensing. Parallel
trade moves products from low price markets to higher priced markets,
he said. Price differences may, however, be short lived. Parallel trade
can interrupt the stable supply chain in importing and exporting countries
and will harm the ability of companies to distribute differentially priced
drugs. Parallel trade can also contribute to trade in substandard and
counterfeit drugs, he added.
Turning to compulsory licensing, Dr Noehrenberg said that it has resulted
in negligible growth in ART in countries such as Zambia, Zimbabwe and
Mozambique. In Zimbabwe the reality following the introduction of compulsory
licences in 2002 is that prices are high — US$1,638 per patient
per year — equivalent to an annual salary. Access remains poor
with fewer than 20,000 out of 1.8 million people living with HIV getting
ART. “Compulsory licensing is not a magic bullet and it is a myth
to think that it will solve health care problems — it will not.”
In conclusion, he said that patents are not barriers to access. “TRIPS
does not block access to medicines. The real barriers to access are lack
of funds, political will and infrastructure. Weakening patents and other
IRPs will not affect these barriers. Compulsory licences and parallel
trade represent false solutions. They help industrial interests, not
people living with AIDS. Partnership, not conflict, is the real solution
to AIDS. Time is running out.” |
The
Pharmaceutical Journal