Regulatory Framework Conditions

The permanent changes to European law on medicinal products are a big challenge for pharmaceutical manufacturers. They include legal and procedural provisions concerning pharmacovigilance, i.e. the safety of medicines, or the harmonization of the requirements of the EU Member States concerning market approval or manufacture, all by themselves welcome objectives. However, the necessary efforts to implement them often outweigh their additional benefit.

Example pharmacovigilance

The most recent revisions of European law on medicinal products related among other areas to pharmacovigilance. However, pharmacovigilance standards in Europe – similar to other sectors of regulation – are already very high. For many stakeholders, further measures require additional efforts including high expenditures of time and money without a perceptible improvement to the safety of medicines. Until several years ago, a risk management plan for medicinal products was only required in exceptional cases. This was changed by the so-called ‘pharmacovigilance package’ of 2010 which also defined the respective regulatory framework conditions. Nowadays, such a plan must be submitted with every application for a marketing authorisation. This even applies to medicinal products with known active substances for which numerous marketing authorisations have already been granted and for which competent authorities have already acknowledged an unremarkable risk profile and so far never required a risk management plan.

The pharmacovigilance package has also placed immediate financial burden on pharmaceutical manufacturers. New pharmacovigilance tasks for the ʻEuropean Medicines Agency’ (EMA), the competent authority for market approval of medicinal products in the EU, need to be financed. These tasks include the conduct of EU-wide pharmacovigilance procedures, the evaluation of safety-relevant information from scientific literature, scientific assessments and comprehensive information for the public. They are financed by fees paid by the marketing authorization holders. The fees cover pharmacovigilance activities at the EU level, especially those related to EU-wide assessment procedures such as ‘Post Authorisation Safety Studies’ (PASS), ‘Periodic Safety Update Reports’ (PSUR) and risk assessments. In addition, all marketing authorisation holders must pay an annual fee.

BAH believes that these fees are inappropriate. Particularly for marketing authorisation holders possessing a large product portfolio or products with a low market share, the fee structure is problematic. In the midterm, such high pharmacovigilance fees could lead to the effect that even products with significant benefit for patients are no longer marketed and accessible to medical practitioners and patients.

Example marketing authorisations

The simplification of procedures for obtaining and maintaining marketing authorisations can be particularly difficult to implement. One example being the ‘better regulation’ initiative of the European system for variations to marketing authorisations. Since 2012 all variations to marketing authorisations in Europe must be submitted to competent authorities according to a uniform system, regardless of whether the marketing authorization has been granted via a European or purely national procedure. Implementation of the system in practice is highly complex and susceptible to errors, and constitutes an enormous workload for marketing authorisation holders and representatives from competent authorities.

Example GMP

The requirements concerning Good Manufacturing Practice (GMP) for the manufacture of medicinal products have risen continuously for many years. The increasing complexity of very detailed rules lead to time- and cost-intensive implementing activities, raising the bar especially for small and medium-size enterprises. In the meantime, as well as the actual manufacture of medicines, the manufacture of active substances and other starting materials including excipients and packaging materials, as well as their distribution channels, have been widely regulated. The respective so-called GMP and GDP rules (Good Distribution Practice) have almost doubled during the last decade. This does not only create additional expenditures of time and personnel for the manufacture and testing of medicinal products, the increasing amount of tests and certificates also makes the manufacture of medicinal products more and more expensive.

Further improvements must be proportionate

Medicinal products which may be placed on the European market according to European law fulfil high safety standards. The requirements concerning manufacture and marketing authorisation are enormous. This high level is the result of step-by-step adaptation of the European law for medicinal products to technical and scientific progress. Future changes must be proportionate. They should not rely exclusively on theoretical improvements, but must also have a benefit for the patient. On this basis it must be thoroughly evaluated how much effort can be expected from all parties involved, if the objective is not the improvement of a result but ‘merely’ the design of procedural aspects.

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