EU pharmaceutical law reform
Times of Malta, 8 September 2011, by Dr Anthia Zammit:
In its efforts to better safeguard public health in the European Union, the European Commission recently embarked on the adoption of a new “pharmaceutical package”, comprising a communication and three legislative proposals aimed at creating harmonised rules in order to better protect public health and ensure the proper functioning of the internal market.
Launched in December 2008, the ambitious package is intended to strengthen the double objective of protecting public health by providing the EU with safe, effective medicines, while creating a corporate setting that stimulates research, boosts innovation and supports competition in the pharmaceutical industry.
The legislative pharmaceutical package is intended to address the scientific and health challenges facing the EU today, and to protect the legal supply chain of medicinal products against counterfeit medicines, and cater for the provision of information to patients on prescription medicines. It is also hoped that the new set of laws will help alleviate inequalities in availability and affordability of medicinal products that still permeate the EU.
The European Commission’s communication seeks to promote discussion with EU member states on increasing the transparency of pricing and reimbursement decisions in order to improve market access. It aims at restoring “the EU’s role as the natural home for pharmaceutical innovation” and intensifying collaboration with major partners in pharmaceuticals, such as the USA. The communication also reiterates the EU’s objective of progressing towards a single, sustainable single market in pharmaceuticals. The legislative proposals for information to patients on prescription-only medicinal products come in light of internet access to information, and indeed the online purchase of medicines, by health care consumers.
The legislative proposals on pharmacovigilance – the science and activities relating to the detection, assessment, understanding and prevention of adverse drug reactions – contemplates the legal set-up of a proper management and recording of Adverse Drug Reactions (ADRs). This is a critical public health tool in identifying unexpected side effects and indicating whether certain side effects occur more frequently than previously known, and whether some patients are more susceptible to ADRs than others.
The reform is estimated to decrease procedural, bureaucratic and administrative expenditure by approximately €145 billion per annum. The findings derived from pharmacovigilance can lead to changes in the marketing authorisation of the medicine (e.g. restrictions in use, changes in dosage, introduction of specific warnings). The strengthening of the Eurdravigilance database, the broadening of the definition of ADRs and the strengthening of patients’ involvement through direct patient reporting are expected to be useful in the detection of potential medication errors associated with medicinal products by member states. The proposal for a European directive on the protection of the legal supply chain against counterfeit medicines was tabled in response to the astronomical increase in counterfeit medicinal products, as countless websites lure unsuspecting patients looking to save on medicines they might not otherwise afford. An even greater fear is that counterfeit medicines might make it to the pharmacy shelves despite the continuous inspections and robust safety measures in place.
In fact 2008 saw a 118 per cent increase in the number of counterfeit medicinal products detained by customs authorities, making medicines the third largest specific product category in terms of quantities of intercepted counterfeit articles. The proposed European directive intends to establish a legal basis for rendering safety-features (such as a serialisation number or seal) on prescription drug packaging mandatory, while also ensuring the possibility of re-packaging. Other proposed amendments include added stakeholder obligations, the prohibition of safety-feature manipulation (e.g. removing or tampering with product packaging, over-labelling) throughout the distribution chain, compulsory auditing of wholesale distributors, strengthened requirements for the importation of active pharmaceutical ingredients and increased transparency of inspection results.
Issues of pricing and reimbursement, diminishing research and development, and the critical concerns of medicines access and availability, continue to dominate the European debate on pharmaceuticals for human use, making the upcoming pharmaceutical package a welcome development in European pharmaceutical reform.
On September 22, the European Parliament adopted the Pharmacovigilance legislative proposal, which is expected to enter into force by the end of 2010 or early 2011, and must be put into effect by member states within 18 months of its publication in the EU Official Journal. While details of the remaining legislative proposals are being discussed at the drawing board, new creative, legal solutions must be found that take into account the profit-driven nature of the pharmaceutical industry and the challenge of protecting the health of consumers.