Seven years of EU pharmaceutical regulation in Malta

Abstract

In an era of globalization, governments are expected to provide safety and welfare for citizens while ensuring a level playing field and boosting competitiveness for businesses. Public authorities regulate in the public interest to protect health, ensure patient access to safe medicines, stimulate innovation, encourage a competitive market, and preserve the environment (1). Malta is an island in the south of Europe with a population of 417 608 (2010). The country became a Member State of the European Union (EU) on 1 May 2004, when a total of 10 European countries joined the EU. During the process of Malta’s preparation for accession to the EU, the country transposed European pharmaceutical legislation into national legislation, leading to publication of the Medicines Act and subsidiary legislation. This established the Licensing Authority — a function which is vested in the Superintendent of Public Health — and the Medicines Authority (2). The mission of the Medicines Authority is the protection of public health in Malta through the regulation of medicinal products and pharmaceutical activities. The Authority is committed to being an effective and supportive regulator with loyalty towards its core values: protection of public health as the purpose of regulation; public trust through an impartial, consistent, disciplined and transparent approach; excellence through competent personnel with integrity, which is based on customer focused, robust, resilient and secure processes and infrastructure.