by Eslam M. Saleh
Amid the COVID-19 global health pandemic, a new governmental agency has been established to regulate and monitor the pharmaceutical industry in Egypt. The Egyptian Drug Authority (EDA) was established by Law No. 151 (2019), which was ratified by President Sisi on 25 August 2019 and stipulated that the agency’s powers were come into force six months hence, on 26 February 2019. However, the law’s executive regulations, required to define the law enforcement mechanisms, were not issued and published until 29 March 2020.
This left the new agency as the successor to three existing bodies: the Ministry of Health’s Central Administration of Pharmaceutical Affairs (CAPA), the National Organisation for Drug Control and Research (NODCAR) and the National Organisation for Research and Control of Biologicals (NORCB). This transition, apparently, was beset by several hitches. During the law’s drafting, the new agency’s jurisdiction over veterinary drugs and vaccines was debated. Furthermore, the governance model adopted by the legislator raises questions over the independence of the new agency and its functions. These and other issues will affect the agency’s ability to meet the considerable COVID19-related challenges it is sure to face in the near future.
Human Vs. Veterinary:
In its early stages, the bill received heated debate among pharmaceutical sector stakeholders, especially the relevant divisions in the chambers of commerce and the Pharmacists’ Syndicate. Additionally, the Veterinary Syndicate objected to authorising the EDA to regulate veterinary drugs and vaccines, previously the remit of the General Organisation for Veterinary Services (GOVS). They argued that Egypt should continue following the example of the US and EU in detaching guidelines on veterinary drugs and vaccines from general regulatory bodies, to instead be covered by a separate agency.
Despite the Veterinary Syndicate’s announcement that they had reached an agreement with the government so that the EDA could be authorised to regulate veterinary ‘drugs,’ with the GOVS to maintain its powers over veterinary ‘vaccines,’ it seems that such an agreement was not fulfilled.
Article 1 of the aforementioned law defines ‘Medical Formulations’ as ‘each product or formulation contains a substance or a set of substances used to treat, precaution, or diagnose humans or animals…’; it also defines ‘Biomedical Formulations’ as ‘each formulation contains a substance or more produced or extracted from a biotech resources including, for example, human vaccines, serums …’ [my emphasis].
As such, it is clear that the two definitions incorporate veterinary drugs explicitly and veterinary vaccines implicitly within the EDA’s scope of function.
Agency Independence and Functions:
According to Article 14 of the law, the EDA is ‘a public service authority.’ It is important to note that the Egyptian legislator appears to have insisted on not granting the regulatory agency the legal qualification as an ‘independent body’. For comparison, the statute described the Electricity Regulatory Authority (ERA) as ‘an independent public authority,’ the National Telecommunications Regulatory Authority (NTRA) was prescribed as ‘a national authority,’ and each of the Egyptian Competition Authority (ECA) and the Consumer Protection Agency (CPA) were established as ‘an authority… with a legal public personality…’.
However, regarding institutional affiliation, the position of the EDA seems to be more independent from the executive than other regulatory agencies, such as the ERA and the NTRA, where the chairperson is the sector-related competent minister. Article 14 affirms that the EDA reports directly to the prime minister.
Furthermore, Article 24 provides for an independent budget for the agency, for the purpose of maintaining its financial autonomy. The key protections associated with this include a diversity of resources through less reliance on the state’s public budget allocations, keeping fees obtained for the agency’s budget, and carrying over annual budget surpluses to the following year.
On the other hand, the agency’s board structure is not well-defined, unlike other Egyptian regulatory agencies, which may raise concerns about transparency with regards to the appointment process. Article 18 stipulates that the agency’s board is to be headed by a Chairperson, who in turn – along with the board members – is a presidential appointment, to serve for a once-renewable four-year term. Neither the number of board members nor their career-related positions are specified by the law.
Concerning the functions of the EDA, Article 17 classifies its powers into three categories: Regulatory Functions (rule-making powers), Executive Functions (licensing and testing powers), and Monitoring Functions (law enforcement powers). The three categories comprehensively cover all phases of activities related to the pharmaceutical industry. Setting rules regulating quality standards of all medical formulas and supplies, licensing and pricing producers and products, and controlling imports, exports and distribution of such products are the major functions mandated to the agency. In order to effectively enable the EDA to perform its supervisory role, Article 28 grants the agency staff members, nominated by the Minister of Justice, law enforcement powers (including inspection) over pharmaceutical entities to ensure the proper implementation of all related decisions and standards, and the power to detect criminal violations related thereto.
For a new agency to have to begin to undertake its responsibilities in the midst of a global viral outbreak brings significant challenges. Three fundamental tasks lie before the agency in light of its stipulated functions:
- Detecting anti-trust practices by local producers and importers of coronavirus-related medication and equipment, and medical supplies required for preventing contagion.
- Monitoring quality standards of local production of medical supplies. For example, the public prosecutor recently announced an investigation into an unlicensed factory involved in producing counterfeit facemasks and alcohol-based sanitiser.
- Supervising the process of clinical trials for the manufacture of a vaccine.
To conclude, in a country with a population of 100 million, the new agency – equipped with far-reaching powers – has been handed a difficult task in regulating this vital economic and service sector. It will have to prove that a regulatory governance model truly works and can make radical positive changes for both the sector and consumers.