Malta Medicines Authority stakeholder meeting on 28th September 2016

Malta Medicines Authority stakeholder meeting – 28 September 2016

The Malta Medicines Authority (MMA) held its annual stakeholder meeting on 28th September. Two of us from Real Generics – Michelle Gafà and Tessa Fiorini Cohen – attended.

The meeting was addressed by Helena Dalli, Minister for Social Dialogue, Consumer Affairs and Civil Liberties and by Anthony Serracino Inglott, Chairperson of the MMA. Various presentations by heads of directorates within the MMA followed.

The initial part of the meeting focused on the MMA’s achievements since the last stakeholder meeting, its strategic plan through 2020, and its upcoming commitments. These include the Joint Audit Programme (JAP) audit in November 2016 (involving inspectors from the Netherlands, Israel and the United States) as well as Heads of Medicines Agencies (HMA) benchmarking in March 2017.

The second part of the meeting was of greater general interest, covering Malta’s upcoming Presidency of the Council of the EU and its bid to host the European Medicines Agency (EMA).


Malta’s Presidency of the Council

Malta will hold the Presidency from January to June 2017. It is a member of the current Presidency trio together with the Netherlands (January to June 2016) and Slovakia (July to December 2016).

During its Presidency, it will host 16 meetings, including two HMA and various EMA committee and working group meetings. An informative website is expected to be set up soon.

Interesting snippets of information gleaned from the meeting:

  • During its Presidency, Malta will organise a European stakeholders’ meeting.
  • There are plans to set up an International Institute for Regulatory Science in Malta.
  • Collaboration with the Bill & Melinda Gates Foundation to organise a meeting between African and European heads of medicines agencies is on the cards.


Malta’s bid to host EMA

Gavril Flores, Director of Strategy, Operations and Regulatory Affairs, harbours no illusions about Malta’s bid. He admits that Malta is a minnow competing with giants (Denmark, France, Germany, Ireland, Italy, Luxembourg, Spain, Sweden), some of whom are lobbying extremely hard to house the Agency. However, the MMA are giving it their best shot.

Although it cannot compete on the size of its life sciences industry or its technological prowess, Malta does have advantages to offer, mostly linked to its comfort and convenience for expatriates and their families, as well as visitors to EMA. Its bid has been studied carefully and is not being submitted capriciously. What does Malta have to offer?

  • Premises purpose-built for EMA.
  • Cost reduction through salary adjustments.
  • English-speaking population (English is an official language of Malta along with Maltese).
  • Personalised relocation support.
  • Well-developed IT infrastructure – Malta is positioning itself as an IT hub.
  • Significant reduction in EMA employees’ commuting time, due to the small size of the island (316 km2).
  • World class healthcare and education, which is free for EU citizens.
  • Excellent connectivity. Mr Flores presented figures to challenge the claim that Malta is harder to reach than other competing countries. If EMA had to relocate to Malta, travel time from 10 EEA Member States would be reduced, and from the remaining Member States (excepting just three) travel time would increase by less than three hours.
  • Last but not least, the fantastic Mediterranean weather.


Photograph: Malta – Golden Bay by Michael Brys, CC BY 2.0

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