Aids Drugs and Trips

8/9/2019 Aids Drugs and Trips

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GlaxoSmithkline

British pharmaceutical, biological,

and healthcare company.

Formed by Merger between GlaxoWellcome

PLC and SmithKline Beecham PLC in 2000.

With a revenue of 24.352 billion (2008)

operating income 8.259 billion (2008) , Net

Income 4.712 billion (2008) and employee

base of over 103,000 (2008) , it is Second

Largest Pharamceutical company by netincome.

Presence across 99 countries in 39 cities.

Global Headquarters located at London , UK.


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GlaxoSmithkline

US Headquarters located at North

Carolina.

Major Contributor for HIV Treatment and

Drug Research. Product Portfolio consist of : -

- Pharamecutical Products.

- Healthcare Products.

Under the AAI (Accelerating AccessInitiative)the company took initiatives for

treatment of HIV specially in Sub Saharan

Africa.


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AIDS- scene in the year 2000


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The disease spreading like fire


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Intellectual property rights

The clauses of this rights are

to promote the publication of ideas,

inventions and creations, in order to make

them available to others, who can thenfurther improve them; this will nurture

scientific progress or artistic inspiration

to provide an economic incentive for

people to invent or to engage in creative

efforts, by ensuring that the originator can

reap financial rewards from his/her efforts


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What is the WTO TRIPS

Agreement?

The WTOs Agreement on Trade-Related

Aspects of Intellectual Property Rights

(TRIPS), negotiated in the 1986-94 Uruguay

Round, introduced intellectual property rulesinto the multilateral trading system for the

first time.


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What is the basic patent right?

Patents provide the patent owner with the

legal means to prevent others from making,

using, or selling the new invention for a

limited period of time, subject to a number of

exceptions.

Under the TRIPs Agreement, protection must

last for at least 20 years from the date of

filing of the patent application.


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Why are patents important?

The costs of pharmaceutical R&D are

high. While the actual amount is being

disputed, it is in any case significant

There is a disclosure requirement, atregistration

Imitation is relatively easy, therefore the

patent is important to protect the invention

the protection of trademarks helps to clean

up counterfeit products from the

marketplace


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What is compulsory licensing?

Compulsory licensing is when a

government allows someone else to

produce the patented product or process

without the consent of the patent owner


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What are parallel imports?

Parallel or grey-market imports products

marketed by the patent owner (or

trademark- or copyright-owner, etc) or with

the patent owners permission in one

country and imported into another country

without the approval of the patent owner.


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What is the Bolar Provision

Allows interested (generic) manufacturers

to start producing test batches of a product

before the patent expires

Facilitates collection of necessary data forsubmission to the registration authorities

Helps to reduce the delay for generic

products to enter the market after the

patent has expired, enhancing competition


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What was the Patent Law

prevailing in India at the time?

Prior to 2005, Indian law provided process

patent protection, so that patented drugs

can be (re)manufactured in India so long

as the production process used is different

from the one that is patented


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The price war

1980 Glaxo introduced AZT

1985 patent was offered to Glaxo

Mid 1980s Glaxo developed lamivudine

and abacavir

2000 Prices lowered in Africa and other

developing countries

Feb 2001 Cipla Ltd of India announced to offer

antiretroviral cocktail to sub Saharan countries

2003 Hetero Drugs and Aurobindo came out with

generic cocktail


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What did Cipla do?

Most of the people suffering from Aids

cannot afford the exorbitant price offered

by drug TNC

Cipla Ltd of India announced to offergeneric antiretroviral cocktail to sub

Saharan countries

The price of this product was about 3% of

that of Glaxo

Was prepared to pay licensing fee of 5%

of its royalties


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GSKs main point of opposition

Ciplas conduct violates the Trade-Related

Aspects of Intellectual Property Rights

(TRIPS) Agreement under the WTO.

Article 31 of the TRIPS allows compulsorylicensing

The only stipulation is that they try to

negotiate acceptable commercial terms

with the patent holder - if that fails, to

adequately compensate the holder foruse of the invention.


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Concerns of other pharma majors

Sustainability and quality of low cost

generics being supplied

if AIDS is the issue today, tomorrow it may

extend to heart disease, cancer or, for thatmatter, any other disease

No incentive to invest the millions required

to discover and develop new drugs, without

intellectual-property protection.

Lack of the political will to act was also one

of the factors that were raised by Glaxo.

Lack of health infrastructure in the

developing countries


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Ghana

In 2000, CIPLA had made shipments of a

combination drug Duovir (zidovudine plus

lamivudine) to customers in Ghana .

GSK claims four patents granted byAfrican Research Industrial Property

Organisation (ARIPO) provides exclusive

rights to its drug in Ghana

Mr Kiige, ARIPOS chief patent examiner

claim that three patents are not valid inGhana

In November 2000, GSK sued in Ghanaian

courts to prevent the sale of Duovir in

Ghana.


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At present, none of the generic

drug manufacturers are allowed

to export generic aids drugs to

Ghana


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South Africa

South African Parliament passed the

Medicines and Related Substances

Control (Amendment) Act in 1997.

To combat higher prices of drugs andmake them affordable , the Act was

introduced.

Provisions for compulsory licensing and

parallel importing of AIDS Drugs and

others.


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Compulsory Licensing

Compulsory Licensing

- Section 15C of the Bill provides for

compulsory licensing.

- Allow South African Local DrugManufacturers to manufacture and

distribute AIDS drugs within South Africa

at affordable prices.

- Reduce Price by 90 percent.


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Parallel Import.

Under Section 15(C)(b) the government

could prescribe parallel imports on

medicines already registered in South

Africa.

It allowed South Africa to import a drug

manufactured and sold at a lower cost

elsewhere.

Government could fulfill the supply of

drugs that could not be met otherwise,under the pricing schemes operating prior

to the introduction of the Act.


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Remuneration and Lawsuit

Proposal for adequate remuneration

A case had been filed by the

Pharmaceutical Manufacturers

Association of South Africa (PMASA), Four members - Merck, Glaxo-SmithKline,

Bristol-Myers Squibb and Boehringer

Ingelheim manufacture AIDS drugs

Remaining 35 members also party in the

lawsuit.


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IFPMA's recommendations

Encourage public-private partnerships for

the development and distribution of

medicines and vaccines where existing

therapies are lacking or not getting

adequately distributed

Foster local industry investment in R&D

and transfer of know-how into developing

countries by accelerating the adoption ofTRIPs standards


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Encourage local innovation by avoiding

price controls, either directly or indirectly

Stimulate the supply of affordable qualitygenerics in developing countries by

working to inculcate the importance of

quality manufacturing procedures locally

Ensure the supply of needed drugs by

working to prevent parallel trade



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Consider creating publicly financed

research centres in the region to foster

medical research, pooling the scientific

expertise and resources of several

countries, to increase the capacity for

research in diseases of regional interest

Join with judicial authorities, the police and

industry professionals to implement anti-counterfeiting legislation. Severe penalties

should be imposed



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Adopt global drug review standards to

speed up the approval of new drugs

Empower consumers to choose well



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Aids Drugs and Trips

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