At loggerheads over patent rights

Multinational pharmaceutical companies hope the Egyptian government will re-institute their rights of product protection. Niveen Wahish reports
A number of multinational pharmaceutical companies, represented by an international organisation, have filed a complaint against several Egyptian pharmaceutical companies which they suspect are marketing imitations of a handful of their products locally. The Ministry of Health is looking into the matter and a decision has not yet been taken.
In a bid to rally public support, some 30 Egyptian pharmaceutical companies jointly announced that the multinational companies are trying to prevent the manufacture of several Egyptian drugs. In doing so, the Egyptian companies said at a recent meeting, the foreign multinationals are challenging Egypt's right to the full grace period before the agreement Trade Related Aspects of Intellectual Property Rights (TRIPS) is applicable to pharmaceutical products. The Egyptian companies claim this would mean their cheaper products would not be available on the market.
The multinationals, on the other hand, assert that their demands do not contradict Egypt's choice to delay the full implementation of TRIPS until the beginning of 2005. Ahmed El-Hakim, Pfizer's director of external affairs and health policy for the Middle East region, said that even while under the grace period, Egypt has certain obligations that were applicable as of January 2000, when most elements of TRIPS should have come into force in the country.
Among those liabilities, El-Hakim said, is the protection of undisclosed information against unfair commercial use and disclosure. According to El-Hakim, prime ministerial decree 2211 was issued in November 2000 to make up for the fact that Egypt's existing IPR laws do not address this issue and to protect data until a new law is promulgated. The decree states that data -- including not only drug composition information, but also test results proving drugs' safety for consumption and efficacy -- may not be "used, relied upon or referred to." A company is required to present this data to the Ministry of Health to obtain marketing authorisation for a product.
In fact, according to TRIPS, "Ministries of Health may not approve new applications for marketing approval submitted by parties that did not either originate the data or receive the permission of the originator until the exclusivity period expires".
Several multinational pharmaceutical manufacturers had discovered that a number of Egyptian companies are marketing or waiting for marketing approval for imitations of some of their products. Jaleen Moroney, acting Chief of Party of Strengthening Intellectual Property Rights in Egypt (SIPRE), a USAID project intended to improve IPR protection in the country, said the reason the Egyptian companies are under suspicion is the fact that it takes years to carry out drug safety testing. On the other hand, she said, "it would only take them six months to reverse engineer [analyse a product to find out its components] a drug."
According to EL-Hakim, the Egyptian companies submitted to the Egyptian Ministry of Health, copies of the undisclosed information of the drugs manufactured by multinationals without any proof that they had carried out the research leading to the information.
Having discovered the violations, the multinationals, represented by Pharmaceuticals Research and Manufacturers of America (PHRMA), an international organisation based in Washington DC representing 100 international pharmaceutical companies, filed a complaint against the Egyptian companies in question.
"The Ministry of Health should be committed to the prime ministerial decision and these products should not be granted the right to market," said El-Hakim, who is also secretary-general of PHRMA Egypt, currently under establishment.
Alternatively, said Moroney, the Ministry of Health should require the Egyptian companies to present their own data. If they do not, they should not be granted marketing authorisation.
Mustafa El-Hadary, head of the drug policies committee at the Ministry of Health, said the ministry was studying the matter and has not decided yet what action it will take, but he declared that "law will prevail".
While Egyptian private sector pharmaceutical companies have refuted the prime minister's decree, multinational companies are bent on doing whatever is legal to preserve their rights. "We are trying to convince the Ministry of Health that the issue is not just about those few drugs, but is more about Egypt's reputation," El-Hakim said.
Makram Mehany, chairman of Global Napy, a private Egyptian pharmaceutical company, has suggested that both sides sit together in the presence of ministry representatives to discuss the matter. "What is happening is not in the interest of the market," he said.
Since 1 January 2000, Egypt has been obliged under TRIPS to protect the data exclusivity of products currently being marketed anywhere in the world even if they have not entered the Egyptian market. The data exclusivity should be respected regardless of the status of patent protection and the protection should extend to cover the conclusions based on the data as well.
According to El-Hakim, inventing a pharmaceutical product is very costly and difficult, sometimes taking 12 to 15 years and costing millions of dollars.
"If protection was not there and exclusivity is not provided for a certain period of time, no one would have the incentive to develop," he said.
The lack of protection also prevents pharmaceutical manufacturers from introducing their latest products immediately into the Egyptian market. "They do not want to bring the drug here because they do not want it to be copied," Moroney said.
More importantly, maintains El-Hakim, Egypt must show it is willing to fulfil its obligations. "As a result of the infringements, Egypt has become subject to international criticism," he said.
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