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Medicinal products for human use
New technologies, therapies and medicines are emerging; this includes regenerative medicine, more personalised treatments, as well as the development of nanomedicines. The Commission is committed to monitoring scientific progress and to constantly review Community legislation in the light of new developments so as to make safe, novel treatments available to patients as early as possible.
Advanced therapy medicinal products are new medical products based on genes (gene therapy), cells (cell therapy) and tissues (tissue engineering). These advanced therapies herald revolutionary treatments of a number of diseases or injuries, such as skin in burns victims, Alzheimer's, cancer or muscular dystrophy. They have huge potential for patients and industry.
The lack of an EU-wide regulatory framework in the past led to divergent national approaches which hindered patients' access to products, hampered the growth of this emerging industry and ultimately affected EU competitiveness in a key biotechnology area.
The EU institutions agreed on a Regulation on advanced therapies (Regulation (EC) 1394/2007 ), designed to ensure the free movement of advanced therapy products within Europe, to facilitate access to the EU market and to foster the competitiveness of European companies in the field, while guaranteeing the highest level of health protection for patients.
The main elements of the Regulation are:
- A centralised marketing authorisation procedure, to benefit from the pooling of expertise at European level and direct access to the EU market.
- A new and multidisciplinary expert Committee (Committee for Advanced Therapies), within the European Medicines Agency (EMA), to assess advanced therapy products and follow scientific developments in the field.
- Technical requirements adapted to the particular characteristics of these products.
- Special incentives for small and medium-sized enterprises.
This new Regulation also marks the recognition that a number of advanced therapy products actually combine biological materials, such as tissues or cells, and chemical structures such as metal implants or polymer scaffolds. These combination products lie at the border of the traditional pharmaceutical area and other fields (e.g. medical devices). They therefore cannot be regulated as 'conventional' drugs and need adapted requirements. In addition, it should be borne in mind that a significant share of economic operators involved in this field are not large pharmaceutical companies, but rather small and medium-sized enterprises or hospitals.
'-Omics' and Personalised Medicine
New genetic technologies such as pharmacogenomics enable scientists to use patients' genetic information in order to better determine the right drug, at the right dose and at the right time. With the emergence of such technologies, personalised medicine is now on the horizon. This field is already affecting the business strategy of pharmaceutical companies, the industry structure (with the creation of highly innovative and specialised small and medium-sized enterprises), the design of clinical trials and the way medicines are prescribed.
Although it is at the moment too early to tell whether pharmacogenomics and other '-omics' technologies will indeed revolutionise the way medicines are developed and prescribed, it is important that the Commission closely monitor this trend towards personalised treatments and reflect on how it can support its development, by regulatory and non-regulatory means.