In March 2014 EMA launched a pilot project to explore the adaptive pathways approach, a scientific concept of medicines development and data generation intended for medicines that address patients’ unmet medical needs.
Much of the impetus behind the adoption of the first law on pharmaceuticals at EU level stemmed from the determination to prevent a recurrence of the thalidomide disaster of the late 1950s early 1960s, when thousands of babies were born with limb deformities as a result of their mothers taking thalidomide as a sedative during pregnancy. This experience, which shook public health authorities and the general public, made it clear that to safeguard public health, no medicinal product must ever again be marketed without prior authorisation. Over the past 50 years a large body of legislation has been developed around this principle, with the progressive harmonisation of requirements for the granting of marketing authorisations and post-marketing monitoring implemented across the entire EU.
To mark the 50th anniversary of the adoption of the first EU pharmaceutical law the European Commission is organising a one-day conference that will take place in Brussels on 28 September 2015. The conference will review past achievements while focusing on the present and future role of EU pharmaceutical legislation in protecting the health of citizens in the EU and in the world, and in promoting advances in science, innovation and public health. Despite the many achievements there are still many challenges ahead. Different stakeholders see these challenges but each from different perspectives. The conference wants to bring to surface these different perspectives in an open and stimulating exchange with representatives from national governments, European institutions, national competent authorities, industry, healthcare professionals, academia and patient groups, with the objective of working towards a shared vision for the future.”
This case study looks at the availability of herbal medicinal products, as well as homeopathic and anthroposophic products. These are three distinct product groups regulated through distinct provisions. In the case of homeopathic products, regulation is primarily through Articles 14 and 16.2 of the Directive 2001/83/EC (described in more detail in the next sections), while in the case of herbal medical products these involve the simplified procedure introduced in Directive 2004/24/EC on Traditional Herbal Medicinal Products (THMPD). The three product groups do however share some attributes:
The discussions were largely devoted to the possibilities to strengthen collaboration on GMP inspections and possible objectives for the TTIP and beyond. Further exchanges of information, notably on current experience of collaboration and on the EU system are due to further inform this priority topic.