Drug patents and their implications on ARV therapy access

[Guest guest]

Drug patents and their implications on ARV therapy access

The issue of drug patents has recently come into focus because of the

ongoing court case between the Swiss pharmaceutical company,

Novartis, and the Indian government, over India's patent laws.

Novartis had applied for a patent on its drug used in cancer

treatment and is suing the government for rejecting their

application.

The company needed the patent decision so it could sell the drug at

the same price as in developed nations, where it retails at more than

ten times its cost in India. Novartis is challenging a specific

provision in India's patent law that restricts patenting of medicines

to innovations only. If Novartis succeeds in having the provision

overturned, patents would be granted far more widely in India, and

the production of generic medicines, such as the ARVs, which have

transformed access to treatment for people living with HIV in

resource poor countries, would be heavily restricted.

The TRIPS agreement is one of many international trade agreements

which countries are compelled to adopt in order to retain WTO

membership. The agreement, known as the Trade-Related aspects of

Intellectual Property Rights, or TRIPS, was introduced in 1995. In

compliance with TRIPS, India began reviewing pharmaceutical patents

in 2005. The Indian patent law has been designed in a way to protect

patients before patents or profits, as allowed by the WTO's Doha

declaration on TRIPS, which includes pro-public health safeguards,

that countries can implement. India has included some of these in its

patent law, including a key provision that any interested party can

oppose a patent before it is granted in a " pre-grant opposition "

process. Oppositions have been filed against many patent applications

on essential medicines that do not warrant patents under Indian law.

The Novartis case has met with much disapproval, especially among

international health and HIV service organisations and treatment

advocacy groups, who have created a petition against Novartis'

challenge.

If Novartis wins this case, it would lead to an amendment of India's

patent law and patenting could spread to several other drugs,

currently produced by India in generic form. This would be a

significant development as over half the medication currently used

for HIV treatment in developing countries reportedly comes from

India: drugs produced by companies in India are among the cheapest in

the world. Because it only recently introduced patent measures, many

of the ARVs India produces are not patented, making the country a key

source of affordable antiretroviral medicines.

What are drug patents?

Drug patents are a form of intellectual property rights. When a

manufacturer comes up with a new drug, other companies might try to

steal or copy their idea. TRIPS prevents this by creating a trademark

over the drug, protecting disclosure of its composition and excluding

others from making, using, selling the product for a minimum period

of 20 years.

What is the rationale behind having patents on drugs?

The need to patent drugs is ostensibly to ensure that the company or

manufacturer that invests in the research for a drug is duly rewarded

for their innovation. Without patent protection, the drug companies

claim, they have little incentive to invest financial and other

resources in the long process of coming up with a drug - from

developing, branding, marketing and promoting it, to paying its

research staff. The reality is likely to be closer to the need to

protect drug companies' profit margins.

Which countries comply with the TRIPS agreement?

All the 148 members of the WTO. From 1995, developed nations were

given a year to ensure that their intellectual property laws complied

with the new TRIPS agreement. Developing nations were given up to

2000, while the least developed countries were given until 2006, and

some 2016, hence India's delay in enacting its patent law. For a

period of 10 years, India had no regulation on product patents. The

WTO however agreed that developing countries that were newly

introducing TRIPS would delay introducing patent regulations, and

that they would not apply to any drug patented before the 1995

introduction of TRIPS.

What is a generic drug?

When a patent expires or is waived, a drug can be made generically. A

generic drug is a 'copy' of the original drug. It contains the same

active ingredients as the original drug but is not sold using the

brand name under which the drug was initially manufactured.

Why are generic drugs so important, especially for treating HIV in

Africa?

The obvious reason is that they are more affordable. Africa bears the

greatest brunt of the HIV epidemic, with more than 50 percent of all

people worldwide living with HIV being in Africa. ART is a lifelong

commitment, both for the patient and their government. With low

laboratory research capacity, poor pharmaceutical facilities and

limited expertise and funding to create original medication, resource

limited countries, especially those in Africa, rely on drugs produced

generically, and more affordably, to meet their treatment needs. A

patented drug means that there is little or no competition for the

manufacturer who produces it. And if it is an essential drug with

high demand, the patent owner can offer it at a price that may be

very high - too high for those who need it most. This is the case

with HIV medication. Most of the first-line HIV drugs were formulated

before 1995 and can therefore be generically produced. However,

patents for the newer second line drugs, and those produced from the

time TRIPS was introduced, have long to expire, meaning that the

companies that produce them have no generic competition and can

therefore charge very high prices.

But competition among generic manufacturers is what helps bring the

cost of HIV treatment down - as Medecins Sans Frontieres (MSF),

notes, such competition over the years has helped bring drug costs

down from $10,000 per patient per year in 2000 to $130 per patient

per year today. But it has been a constant struggle to maintain this

position. One recent example is that of Combivir_, a first line drug

that contains two pre-1995 drugs, zidovudine and lamivudine. The two

separate drugs can be copied legitimately. However, the combination

ARV that contains the two drugs was patented after 1995. Last year,

Glaxo Kline (GSK), which produces Combivir, applied for a patent

over the drug. It only withdrew the application after facing strong

opposition from HIV advocacy organisations who contended that

Combivir was not really a new drug, but a mere combination of pre-

existing drugs.

What are the other debates around generic drugs and patents?

One of the main issues is the slow rate at which developed nations,

particularly the US, are moving to embrace funding for production of

cheaper generic ARVs, especially from foreign nations. They feel that

generic manufacture damages international trade and affects the

domestic profits of the patent holder, that is, the large

pharmaceutical company which produces the well-known branded product.

The US Food and Drug Administration (FDA) is said to have stringent

testing standards for generic drugs. On the whole, the FDA registers

fewer generic ARV drugs than the World Health Organisation's

prequalification project for ARV procurement - a programme that

prequalifies drugs after verifying that they are safe for use.

Following on from this is the five-year US President's Emergency Plan

for AIDS Relief (PEPFAR), which operates in 15 developing nations,

mostly in Africa and Asia. PEPFAR has been reluctant to allocate a

substantial budget towards producing generic HIV drugs for its

programmes, partly because only ARVs approved by the FDA can be used

in the programme. However, there are suspicions that the real reason

for this is the influence big pharmaceutical companies are said to

have over the Bush administration. Estimates however show that if the

programme used cheaper generic drugs instead of the more expensive

brand-name drugs, the number of HIV patients on PEPFAR receiving ART

would increase tenfold - a crucial step towards meeting treatment

needs in resource-poor settings, as well as preventing unnecessary

deaths from HIV.

http://www.mmegi.bw/2007/February/Wednesday7/170.php