Interview: Sara Masmoudi

How is the pharmaceutical industry impacted by trade agreements with partners such as the EU?

SARA MASMOUDI: Authorities are currently considering the Deep and Comprehensive Free Trade Area with the EU, which unfortunately would not support the development of technology and the transfer of knowledge in the pharmaceutical industry. Instead, it would accentuate the asymmetry between the EU and Tunisia, in favour of the EU. First, the Tunisian pharmaceutical industry mainly manufactures generics and licensed drugs from international firms. In 2018 local drug manufacturing increased by 18% and local manufacturing of generics grew by 24%, with 62% of the private sector in local manufacturing. In contrast, the EU has historically been more innovative as it has the resources for research and obtaining patents. The provisions proposed by the Deep and Comprehensive Free Trade Area for the extension of patents would delay Tunisian patients access to innovative medicines. Furthermore, it would delay the possibility for Tunisian firms to market them. Second, Tunisia’s access to the European market is not equal to the opportunities offered to a European operator in Tunisia. Only European operators are able to file applications for marketing authorisation (MA) in Europe and as such, Tunisians are limited to licensed activities or subcontracting. On the other hand, any European operator has the right to apply for a MA in Tunisia. Lastly, the proposed provisions are not in line with current intellectual property agreements, especially in terms of technology and knowledge transfer. Pharmaceuticals should be excluded from the agreement to protect the local industry against these uncompetitive terms.

In what ways will the creation of a national drug agency benefit the pharmaceutical market?

MASMOUDI: Despite efforts made to accelerate the process in 2017, in 2019 there are still long delays in granting MAs. Operations are monitored through different directorates under the Ministry of Health, however, there is no one authority coordinating the four main bodies. The creation of a national drug agency will ensure better supervision and improved control. Coming back to the MA granting process, better resources would help develop post-marketing oversight, as a considerable part of the efforts made thus far has focused on pre-marketing. In fact, post-marketing controls are a sign of the maturity of the pharmaceutical sector.

What must be done to support the development of biomedical production in Tunisia?

MASMOUDI: Biomedicals are at the heart of where the industry is going, a trend that has been seen in markets around the world. Indeed, seven of the top-10 bestselling drugs in 2018 were biologics. However, biotechnology drugs represent just 13% of the total medicines marketed in Tunisia, compared to a global average of 28%. Considering that these increasingly expensive drugs will only be accessible through the development of biosimilar manufacturing, we must secure a reliable domestic supply. To achieve this, a clear and long-term vision is required.

Looking forwards, how do you expect domestic bioequivalence centres to perform?

MASMOUDI: The first Tunisian bioequivalence centre was created in 2010 and authorised in 2018, and a second centre is currently under development. There are a number of procedures, studies and initial trials that must be done before any centre becomes fully operational, which makes starting such a facility timeand resource-intensive. A lack of local bioequivalence centres has been a setback to the industry, but there is clear room for growth. Considering Tunisia’s high levels of scientific capacity and location, the country should have between 10 and 15 bioequivalence centres. Such an expansion would make file constitutions faster, control actions easier and attract foreign drug makers.