How Changing Drug Patent Rules Will Affect Developing Nations

After years of legal battles, a global
agreement has been reached for developing countries to buy – and
for drug manufacturers to produce or import – generic medicines
without breaching patent rules. The Conversation Africa’s Health
and Medicine Editor Candice Bailey asked Natalie Schellack to
explain what this means for the developing world.

Are drugs about to become cheaper for
poor people in developing countries? Why?

Through the World Trade Organisation an
agreement was reached in November 2015 for the world’s poorest
countries to buy — and for drug manufacturers to produce or import
— generic medicines without breaching patent rules until January 1
2033. The decision was taken by the organisation’s Council for
Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Put simply, the need of a nation trumped
the right to derive protected benefit from a patent. This
initiative will help developing countries come up with better
policies. It will provide legal certainty, which should lead to
better access and more affordable drug prices.

The agreement is good news for all
countries in the Southern African Development Community as members
of the World Trade Organisation (with the exception of the
Seychelles). They’ll be able to incorporate the TRIPS agreement
into their national laws. The community’s protocol on Trade
confirms this position.

South Africa, as a signatory to the
TRIPS agreement, is allowed to pass intellectual property
legislation, inclusive of patent laws, so that intellectual
property rights do not become barriers to legitimate trade while
ensuring the technology is transferred and disseminated in line
with social and economic welfare.

If South Africa actively participates in
this opportunity for more generic trade, medicines should be more
affordable.

South Africa has been fighting for
access to generic drugs for some time. In the late 1990s around 40
big pharmaceutical companies such as GlaxoSmithKline and Boehringer
Ingelheim filed a lawsuit to the Pretoria High Court against the
South African government due to the importation of generic
anti-retroviral medicine to treat the HIV/AIDS pandemic.

Millions of people were suffering from
HIV/AIDS and could not afford the original brand-name medicines.
The South African state was trying to find a way to guarantee their
health. After three years the court overruled the patent law in
this case and recognised the right to health as a basic human right
of South African patients.

How do patents affect
prices?

A patent in this context is when a
pharmaceutical company develops a new drug for a disease. The
company sells it under a “brand name”. The patent protects the
pharmaceutical company’s right to manufacture and market the drug
to profit from it. This helps recover the costs that have gone into
developing the drug.

In most cases the drug patent is awarded
for around 20 years. Once the patent has expired other companies
can “copy” and manufacture the drug.

Generic drugs have to be near-identical
“copies” of the branded drug. For example, they must be identical-
or “bioequivalent”-to a brand name drug in dosage form, safety,
strength, route of administration, quality, performance
characteristics and intended use. In South Africa this is regulated
by the Medicine Control Council of South Africa.

For a developing country like South
Africa, the most effective and sustainable way to bring down the
price of a drug is by driving competition between different generic
manufacturers. This can’t be done if a medicine is still under
patent and the patent owner is not willing to allow competition.
Preventing competition can drive up the price to an artificially
high level

Developing countries can’t afford this.
Life-saving treatments for diseases such as HIV/AIDS, tuberculosis
and malaria are needed. The price of medicine for people with these
diseases is a matter of life or death.

South Africa’s draft Intellectual
Property Protection Policy of 2013 is designed to reform the
country’s patent law and to address various shortcomings that
hamper access to medicine. The draft policy provides public health
safeguards and promotes cooperation between ministries. And more
recently, South Africa’s cabinet approved a new Intellectual
Property framework.

The three-year delay in finalising the
policy first set out in 2013 has affected the health of certain
patients adversely. Two examples stand out. Patients with
multidrug-resistant tuberculosis (MDR-TB) struggle to pay for one
of the medications they need called linezolid. The hepatitis B
medication, entecavir, is another example. It remains inaccessible
to most people because it’s so expensive – while generic products
are available outside South Africa at prices that are around 84%
lower.

Once the policy becomes law, South
Africa could be a role model for the rest of the world in
prioritising people’s health over profit.

What more needs to be
done?

The process of finalising the
Intellectual Property Protection Policy needs to be treated with
urgency. The Department of Trade and Industry and all ministries
involved must continue to prioritise turning it into law.

This will mean more affordable medicines
can become available.

But there are other steps that can be
taken too.

The most effective and sustainable way
to bring down the price of a drug is through competition between
manufacturers.

Investment is also needed. This can be
promoted by having large pharmaceutical companies invest directly
in South Africa to boost local production of medicines. And the
approval process for new medicines should be streamlined by the
Medicine Control Council.

Another market in South Africa that
should get more attention is clinical trial research. This would
not only allow research into conditions inherent to South Africa,
it would also be an investment in local specialists.

The distribution of medicines throughout
South Africa by the National Department of Health should be
streamlined to avoid medicines being unavailable. One solution
could be to transfer logistical and distribution costs of medicines
to the suppliers to avoid delays, additional transport costs and
stock-outs.

Disclosure
statement

Natalie Schellack does not work for,
consult, own shares in or receive funding from any company or
organization that would benefit from this article, and has
disclosed no relevant affiliations beyond the academic appointment
above

The post How Changing Drug Patent Rules Will Affect
Developing Nations appeared first from online sources and was reposted by the community on Welcome to 9jalegal –
Nigeria’s Leading Legal Information and Services Portal.

After years of legal battles, a global
agreement has been reached for developing countries to buy – and
for drug manufacturers to produce or import – generic medicines
without breaching patent rules. The Conversation Africa’s Health
and Medicine Editor Candice Bailey asked Natalie Schellack to
explain what this means for the developing world.

Are drugs about to become cheaper for
poor people in developing countries? Why?

Through the World Trade Organisation an
agreement was reached in November 2015 for the world’s poorest
countries to buy — and for drug manufacturers to produce or import
— generic medicines without breaching patent rules until January 1
2033. The decision was taken by the organisation’s Council for
Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Put simply, the need of a nation trumped
the right to derive protected benefit from a patent. This
initiative will help developing countries come up with better
policies. It will provide legal certainty, which should lead to
better access and more affordable drug prices.

The agreement is good news for all
countries in the Southern African Development Community as members
of the World Trade Organisation (with the exception of the
Seychelles). They’ll be able to incorporate the TRIPS agreement
into their national laws. The community’s protocol on Trade
confirms this position.

South Africa, as a signatory to the
TRIPS agreement, is allowed to pass intellectual property
legislation, inclusive of patent laws, so that intellectual
property rights do not become barriers to legitimate trade while
ensuring the technology is transferred and disseminated in line
with social and economic welfare.

If South Africa actively participates in
this opportunity for more generic trade, medicines should be more
affordable.

South Africa has been fighting for
access to generic drugs for some time. In the late 1990s around 40
big pharmaceutical companies such as GlaxoSmithKline and Boehringer
Ingelheim filed a lawsuit to the Pretoria High Court against the
South African government due to the importation of generic
anti-retroviral medicine to treat the HIV/AIDS pandemic.

Millions of people were suffering from
HIV/AIDS and could not afford the original brand-name medicines.
The South African state was trying to find a way to guarantee their
health. After three years the court overruled the patent law in
this case and recognised the right to health as a basic human right
of South African patients.

How do patents affect
prices?

A patent in this context is when a
pharmaceutical company develops a new drug for a disease. The
company sells it under a “brand name”. The patent protects the
pharmaceutical company’s right to manufacture and market the drug
to profit from it. This helps recover the costs that have gone into
developing the drug.

In most cases the drug patent is awarded
for around 20 years. Once the patent has expired other companies
can “copy” and manufacture the drug.

Generic drugs have to be near-identical
“copies” of the branded drug. For example, they must be identical-
or “bioequivalent”-to a brand name drug in dosage form, safety,
strength, route of administration, quality, performance
characteristics and intended use. In South Africa this is regulated
by the Medicine Control Council of South Africa.

For a developing country like South
Africa, the most effective and sustainable way to bring down the
price of a drug is by driving competition between different generic
manufacturers. This can’t be done if a medicine is still under
patent and the patent owner is not willing to allow competition.
Preventing competition can drive up the price to an artificially
high level

Developing countries can’t afford this.
Life-saving treatments for diseases such as HIV/AIDS, tuberculosis
and malaria are needed. The price of medicine for people with these
diseases is a matter of life or death.

South Africa’s draft Intellectual
Property Protection Policy of 2013 is designed to reform the
country’s patent law and to address various shortcomings that
hamper access to medicine. The draft policy provides public health
safeguards and promotes cooperation between ministries. And more
recently, South Africa’s cabinet approved a new Intellectual
Property framework.

The three-year delay in finalising the
policy first set out in 2013 has affected the health of certain
patients adversely. Two examples stand out. Patients with
multidrug-resistant tuberculosis (MDR-TB) struggle to pay for one
of the medications they need called linezolid. The hepatitis B
medication, entecavir, is another example. It remains inaccessible
to most people because it’s so expensive – while generic products
are available outside South Africa at prices that are around 84%
lower.

Once the policy becomes law, South
Africa could be a role model for the rest of the world in
prioritising people’s health over profit.

What more needs to be
done?

The process of finalising the
Intellectual Property Protection Policy needs to be treated with
urgency. The Department of Trade and Industry and all ministries
involved must continue to prioritise turning it into law.

This will mean more affordable medicines
can become available.

But there are other steps that can be
taken too.

The most effective and sustainable way
to bring down the price of a drug is through competition between
manufacturers.

Investment is also needed. This can be
promoted by having large pharmaceutical companies invest directly
in South Africa to boost local production of medicines. And the
approval process for new medicines should be streamlined by the
Medicine Control Council.

Another market in South Africa that
should get more attention is clinical trial research. This would
not only allow research into conditions inherent to South Africa,
it would also be an investment in local specialists.

The distribution of medicines throughout
South Africa by the National Department of Health should be
streamlined to avoid medicines being unavailable. One solution
could be to transfer logistical and distribution costs of medicines
to the suppliers to avoid delays, additional transport costs and
stock-outs.

Disclosure
statement

Natalie Schellack does not work for,
consult, own shares in or receive funding from any company or
organization that would benefit from this article, and has
disclosed no relevant affiliations beyond the academic appointment
above

The post How Changing Drug Patent Rules Will Affect
Developing Nations appeared first from online sources and was reposted by the community on Welcome to 9jalegal –
Nigeria’s Leading Legal Information and Services Portal.