AIFA and the Malta Medicines Authority sign a memorandum of understanding

The President of the Italian Medicines Agency Robert Nisticò and the Director of the Malta Medicines Authority Anthony Serracino-Inglott have signed a strategic partnership agreement on pharmaceuticals, with the aim of strengthening collaboration in the Mediterranean area, enhancing the role of the two countries in European pharmaceutical policies, and addressing common challenges, such as access to innovation, sustainability of the system, and management of shortages.

The Memorandum of Understanding (MoU) was signed in Rome, at AIFA headquarters, during a bilateral meeting also attended by Malta’s Minister for Health and Active Ageing, Surgeon Jo Etienne Abela.

‘This memorandum of understanding further strengthens the historical ties between Italy and Malta,’ said Nisticò, ’A friendship that is not just geographical, but based on shared values, cooperation, and a relationship that has been renewed and consolidated for over sixty years. Italy and Malta are like two brothers: one larger, the other smaller, but united by a common destiny in the heart of the Mediterranean’. In particular, the President of AIFA recalled, ‘pharmaceuticals are a strategic sector of excellence for both our economies. And we are both aware that pharmaceutical innovation is perhaps one of the greatest challenges ahead of us. Research runs fast, but the costs risk becoming unsustainable if we are not able to reward innovation that offers real added value from a therapeutic point of view. It will therefore become crucial to commensurate costs with the actual value of new therapies, avoiding the dispersion of resources, and to update the decision-making processes for the reimbursability of medicines, which will have to be timely and adapted to changes in the healthcare landscape, also to respond to emerging therapeutic innovations’.

‘Ensuring effective and safe medicines, facilitating access to innovation and promoting research: with this Memorandum of Understanding we consolidate a joint commitment on these three pillars,’ said Health Minister Abela. The Director of the Maltese Medicines Authority emphasised the importance for the European Agencies to ‘act together in the international arena, harmonise processes and objectives as much as possible to prevent bureaucratic issues from impeding citizens’ access to medicines’.

 ‘Bilateral relations between sovereign states, with a continuous exchange of information and projects in the field of drug regulation,’ added AIFA’s administrative director, Giovanni Pavesi, ’are increasingly significant, also in view of coordinated policies at European level.

The MoU expresses a shared vision, with which Italy and Malta put up a common front to face important challenges for the Mediterranean area and Europe in general. The MoU – lasting three years – aims to promote: the exchange of information, expertise and best practices in the field of European pharmaceutical policies, health technology assessment and pricing and reimbursement policies; cooperation on digitalisation, automation and artificial intelligence; joint applications to EMA’s calls for international cooperation, to strengthen the role of both agencies in global health initiatives; and the management of health emergencies.

The collaboration will also cover centralised procedures on medicines, inspections to verify compliance with good practices, and the strengthening of staff skills in specific key areas for both Agencies. Among the objectives of the MoU is also the promotion of pharmaceutical and biotechnological investments, with the support of European funds, to boost pharmaceutical innovation in the Mediterranean.