• The establishment of pharmaceutical and medical device factories and the registration of their products is not linked to EU-based registration system.

• Adopt the EU-based registration system and approve a third party to implement it via the EDA.

• The lack of a futuristic vision or a short- or long-term plan for the pharmaceutical sector; this has created administrative hurdles and conflict among the various competent agencies. 

• Expedite the development of a strategic vision for the pharmaceutical sector to guide its direction in the future; ensure the engagement of all stakeholders in the process. 

• The lack of adequate and clear definitions, as well as the persistent and intentional conflation of pharmaceutical and non-pharmaceutical (medical devices) industries, which are different; this lack of differentiation poses threats to the non-pharmaceutical industries

• Make the necessary distinction between both industries, and ensure that they are treated separately. 

• The introduction of the term ‘medical preparation’ to “obliterate the identity” of “pharmaceutical preparation”.

Do not conflate ‘medical preparation’ and ‘pharmaceutical preparation’.

• Imports of medical appliances (for the benefit of public hospitals and universities) are granted exemptions under Chapter 4 of the new Customs Law; this undermines the competitiveness of local industries as they do not enjoy the same exemptions, which range between 5-30%, on imports of production inputs; thus, both domestic and foreign investors are disincentivized from investing in these industries.

• Eliminate any preferential treatment given to imported products or grant domestic manufacturers the same advantages; develop an investment plan to encourage the production of needed products that are currently imported, including making available low-interest, medium and long-term loans.

The lack of a consistent export assistance strategy.

• Ensure that banks offer low-cost export finance facilitation services.

• Ineffective oversight over the legal and illegal markets for medical devices—failure to follow a robust supply chain monitoring process to detect informal markets.  

• Enforce the law, and criminalize the sale and purchase of unregistered medical devices.  

• Currently, the government is heading in the right direction with regard to transforming the domestic single-use syringes industry, moving from the conventional to the full-safety model. That said, this shift is expected to take more than 18 months, required for manufacturing the needed machines and equipment,  as well as register the products in Egypt.

• Provide the necessary support to the single-use syringes factories, which total 16 and employ approximately 4,800 workers; grant them a three-year transitional period to complete the shift.

• Egypt bans the importation of used medical devices, and does not make a distinction between electronic and non-electronic ones. Such devices do not pose any health risks, and many are given as donations from reputable medical establishments.  Additionally, the procedures for importing any medical device or equipment is too cumbersome.

• Review all import procedures related to medical devices, and do not restrict importation to agents. At the same time, develop standard specifications for medical devices.

There are number of concerns regarding the Executive Regulations of Law 151 of 2019, including the following:

• EDA’s is given oversight responsibly over the manufacturing of medical devises, which is primarily an engineering industry; EDA lacks the technical and engineering expertise to fulfil this responsibility, which will negatively impact the engineering industries in Egypt.
• The overlapping jurisdiction between EDA and IDA regarding the licensing of factories that produce medical devices.
• The authority to accredit factories and medical products has been transferred from the Egyptian Accreditation  Council to EDA.
• The imposing of price controls on medicinal products, which are sensitive to market conditions and changes. Thus, it is not possible to fix prices; more so in any case, this requirement  contradicts what is stipulated in the Investment Law.
• EDA did not set any guidelines and specifications for registering medicinal products;  at the same time, it is not allowing the trading of any product without being registered.

• Take the necessary action to immediately halt the implementation of the Executive Regulations; put forward Law 151 of 2019 for discussion and ensure that all stakeholders, including technical and oversight agencies, are involved to provide the needed support for the medical devices industry.