Egypt is an attractive location for clinical trials by pharmaceutical multinationals. There is a high number of inhabitants – and thus patients, the clinics are well equipped compared with the rest of the region, and the costs are very low. Swiss companies are especially active in the country: on 15th April 2018, 42 clinical trials by pharmaceuticals multinationals were running in Egypt, of which 17 organised by Roche or Novartis – more than 40%.
Violation of international standards
In 2016, Public Eye and its Dutch and Egyptian partners had published a report of 60 pages on clinical trials in Egypt. Their conclusions were unequivocal: in many cases, international standards were not respected – even by Swiss multinationals. Some of the drugs tested in Egypt were never put on the market there, and others were so expensive that almost no-one can afford them, which constitutes a clear violation of ethical directives. In many cases, the question of the voluntary participation of the patients is uncertain: did they only agree to participate in the trial because they were in economic distress?
The Swiss, Dutch and Egyptian media relayed these results extensively. In Egypt, there were sometimes violent reactions among the population, according to information from our local partner Ayman Sabae from the "Egyptian Initiative for Personal Rights" (EIPR). Some even called for the resignation of the government for authorising these kinds of tests. That government is still in place, but our report has been used as the basis of a draft law on clinical trials that will be debated in Egypt.
An inadequate legal basis
The rules pertaining to the organisation and supervision of clinical trials are too vague in the country, and the responsibilities of the various parties are not clearly established. This makes it difficult to get those companies whose trials are not conformant to the code of ethics to face up to their responsibilities. This is why our report also called upon the Egyptian authorities to take measures.
A new law should allow the Egyptian population to benefit from clinical trials, as we wrote in our recommendations. We also demanded the right to information for patients, to guarantee voluntary participation conformant to international ethical standards. Finally, we demanded that the right of patients to continue treatment after the end of the study be protected.
In brief: we requested that the authorities ensure that international ethical directives be respected. When the Health Minister presented the draft law to Parliament, on the 25th February 2018, he quoted the demands of our report verbatim, to the satisfaction of Ayman Sabae.
A big transparency problem
However, our Egyptian partner can only guess the general content of this draft legislation. His organisation is fighting for the right to view this document, but the Health Minister is rather laconic on the subject. No guarantee has been provided as to the duration of the process of consultation currently in progress. “In Egypt, we have a big problem with transparency,” he admits.
The decision could be taken any day now, but it is also possible that it could take years! Before the law comes into force, it will be necessary in any case to wait for the signature of various decrees of application, which itself could take a minimum of six months.
Our research has at least had the merit of creating a controversial debate on clinical trials in Egypt. While a section of public opinion condemns the use of the Egyptian population as guinea-pigs by international pharma companies, strong reservations have also been expressed in religious circles because of blood and tissue tests. According to the internet site of the Egyptian newspaper Shorouk News, a professor of law had declared that the draft legislation goes against Islamic law and the Egyptian constitution.
Fear of losing a source of income
Some political personalities have contributed to the debate with financial arguments. The president of the Commission for Education and Research of the Chamber of Representatives has for example calculated the importance of income linked to clinical trials for developing countries. According to him, these programmes are one of the main sources of revenue in Jordan, where drugs testing enabled earnings of billions of dollars. In Egypt, the number of clinical trials is decreasing, but as the trials last several years, this trend may be due to the fact that several studies have ended. However, it is also possible that pharmaceutical companies, reacting to public reports from various media and NGOs, are now hesitating to launch new trials in the country.
The results of our report were confirmed in a one-hour programme broadcast by the Deutsche Welle Arabia television channel on 11th April 2018 on clinical trials in Egypt. The programme presented other cases of clinical trials non-conformant to ethical directives and Egyptian law, and insisted on the importance of a new law to provide a legal and ethical framework for clinical trials. One can only hope that the members of the Egyptian parliament move this draft legislation forward with the urgency it merits.
Roche instrumentalises a participant in its clinical trials and loses at a Swiss tribunal
On the 1st December 2016, Public Eye received from the regional tribunal of Berne-Mittelland a “request for provisional measures combined with a request for a super-provisional measure”. This had been put forward by the Basel-based lawyer Benedikt Suter, apparently mandated by one of the people who had confided his experiences as a participant for our report on ethical problems in drugs trials performed by Swiss companies in Egypt.
In fact, various legal documents and contextual information show that if the participant in question had so suddenly rescinded his consent to the publication of his photos and declarations, after having given them to us of his own volition and on several occasions, it was because he was under pressure from the Basel-based pharma giant Roche. This was also the conclusion of the SonntagsZeitung newspaper in its edition of 12th March 2017, in which this weekly publication relates the story of this emblematic botched attempt at intimidation.
Further reading on this subject:
The article (in French) in La Liberté of 1st April 2017 : Roche aurait intimidé un cobaye