by Karimullah Adeni

The state of a nation is determined, primarily, by the state of its people, the welfare of its people and the health of its people. To term the state of health care, in this country, as being poor would be an understatement indeed. It is common knowledge that there is a clear shortage of facilities, the doctors and the most importantly, the availability of the reasonable priced medicines. The underprivileged class of our society cannot even fathom affording medical care yet they remain the most in need of such care. It is cruel irony that still makes the business of healthcare prospering like it does.

Recent reports suggest that pharmaceutical companies are piling in huge profits from the sale of essential medicines, at the ultimate cost of the consumers. The profits come by directly, from the prohibitive prices of medicines' a many of which are life saving and hence a necessity. A WHO report ascribed the price increase, mainly for two reasons, i.e. shortage of medicines in the market, and the patenting of drugs.

The patenting of drugs has remained a contestable issue for many years, gaining notoriety with the non-availability of AIDS medicines in Africa due to restrictions imposed by patent law. Yet Patent Law remains the only legal remedy available in the securing investors' inventions; that it adds to the cost of manufacturing drugs is indisputable. Researchers of new drugs commit an immense amount of resources, both human and financial, in the development of these drugs and the patent law provides them with an opportunity at recouping those costs by selling the drugs at a premium. All good and fair, however, problems arise when the premium afforded to pharmaceutical companies is given at the cost of an entire nation's health. The purpose of medicines and the healthcare is to cure, which it must always take precedence over the recouping factor of the cost sand making profits. The exorbitant prices of patented life saving vaccines jeopardize the lives of millions in developing and the under-developed countries where these medicines are most likely to be used.

An outcome, such as, this would certainly be inequitable; therefore, provisions have been made in patent law to counter this, and allow access of medicines to those in urgent need, though these provisions have hardly been availed of, is entirely another question. The TRIPS agreement is the treaty that governs patent law globally; it has extended the power of the statutory body to issue Compulsory Licenses to third parties for the manufacture of patented drugs. The issuance of such a license is premised in the public interest to meet the need, and to protect the welfare and health of the masses. In particular such licenses can be granted, under law, in matters relating to national security, nutrition and health of the public or for the development of the national economy. These licenses would have a positive impact, profoundly, on a society.

In legal terms Compulsory Licensing allows a government to license a company, government agency or other party the right to use a patent without the consent of the patent holder. The objective of granting Compulsory Licenses is to prevent the abuse of monopoly granted by the patent, and to safeguard the public welfare and health care issues prevailing in the nations.

A patent is granted to provide legal protection to an invention from getting infringed. However, this legal protection is subjected to a time period of four years after the date of grant of patent for bringing the patent into utility. Hence, where a patent has not been exploited in a manner, which contributes to the promotion of technological invention and to the transfer and dissemination of technology, the Federal Government has the power to decide that a Government agency or a third person, designated by the Federal Government, may exploit a patented invention.

The Federal Government shall, before taking any decision give the owner of the patent, and any interested person, an opportunity of being heard if he wishes to be heard. Though, in the circumstances that the patent holder refuses to let a compulsory license be issued or if the patent holder allows licensing but not on reasonable commercial terms, the Federal Government shall have the power to grant the compulsory license without the consent of the owner of the patent. Here, the interested third party shall have to present evidence that the patent holder had been approached for his consent before coming to the Federal Government.

The system of Compulsory Licensing is an integral part of Patent Law and one that is present in most countries of the world, which includes Pakistan and Great Britain, from whom we have adopted the Patent & Design Act, 1911. This system is a century old and was incorporated in the UK Act of 1907. It is principally founded upon the idea that a Government must safeguard the interests of its people, which most importantly include their health.

In the old Patents & Design Act, 1911, the provisions were made vide section 22, 23 and 23-A, whereby any person interested may present a petition to the central government, which shall be left at the Patent Office, together with the prescribed fee, alleging that the demand for a patented article, in Pakistan, is not being met to an adequate extent and on reasonable terms, and praying for the grant of a compulsory license, or, in the alternative, the revocation of the patent. This remedy is also available in the new Patent Ordinance, 2000 vide section 59, whereby the Controller has the power to grant compulsory licenses. The exploitation of the patented invention shall be limited to the purpose for which it was authorized and shall be subject to the payment to the said owner an adequate remuneration therefore, taking into account the economic compulsions of the federal government, the authorization as determined in the said decision, and where a decision based on the need, has been taken to correct anti-competitive practices.

it is a common misconception that a country would issue compulsory license only in the case of an emergency. The Doha Declaration on Public Health confirms that countries are free to determine the grounds for issuing compulsory license and to a great deal, offer legal flexibility. However, the onus is on the proposed user to take necessary efforts to avail the flexibility on offer within Compulsory Licensing.

However, this does not mean that the entire system of Patent Law is invalidated by the provisions on Compulsory Licensing, according to section 59(2), a non-voluntary license shall not be issued if the owner of the patent satisfies the controller that circumstances exist which justifies the non-exploitation or insufficient exploitation of the patented invention in Pakistan. Thus it is the existence of a framework that includes respect for Patent Law alongwith Compulsory Licensing that allows the establishment of a much fairer legislative system.

Example: To illustrate the current situation and how compulsory licensing would prove serving in improving access to medicines in developing countries where the rights of patent holders are protected.

Let us use the following example; a thousand children die of dysentery alone every year.

Uganda and Kenya are neighbors and similarly poor countries. Yet a child getting dysentery in Uganda has a much better chance of surviving than a child getting dysentery in Kenya. The reason is that Ciprofloxacin, an anti-biotic that kills the Shigella bacteria that cause dysentery sell for just seven US cents per tablet in Uganda, whereas in Kenya the same drug is priced at US$ 2.42 making this necessary lifesaver far beyond the means of the parents of most of the children getting dysentery. The simple reason for this vast price difference is that Kenya has laws respecting patents and Uganda has not.

Let us take another example; an antibiotic used to treat respiratory and sexually transmitted infections (Azythromicin), which are among the most highly prevalent disease in developing countries, cost US$ 2.70 per 259 gm capsule in Kenya where it is patented by the pharmaceutical company Pfizer and marketed under the trade name Zithromax® is over three times cheaper than the trade price in Kenya (US$ 0.84). Now if the Kenyan government issued a compulsory license for Azythromicin, generic versions of the drug would be able to treat five to seven times more patients on the same budget.

In attempting to justify their position and role in hindering access to essential medicines, multinational pharmaceutical companies continue to claim that lower prices for drug therapies in developing countries would be a serious threat to their research and development funding. This is, however, a very weak argument indeed. Although the majority of the world's population lives in developing countries, these countries represent only a small proportion of the global pharmaceutical market. It is even more startling to note that Compulsory Licenses have been issued in the richest countries of the world.