Major progress has been made on two elements of the European Commission’s Pharma Package proposals (see ECHAMP E-news March 2010 ): pharmacovigilance and counterfeit medicines. On 27 April, amendments to both elements were adopted by a large majority in the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI Committee).

270 amendments were tabled in relation to pharmacovigilance  (Rapporteur: Linda McAvan MEP, UK-S&D) and 374 amendments for counterfeit medicines(Rapporteur: Marisa Matias, P – GUE/NGL). After intensive discussions a small number of amendments and compromise amendments have been adopted and will be put for voting in the European Parliament plenary session in the middle of June.  Under certain strict rules, additional amendments can be tabled for the plenary voting as well. Further contact between Members of the European Parliament, the European Commission and stakeholders might still bring additional points of view and some new amendments.

There are a number of points of specific relevance to homeopathic medicinal products, some of which will require further advocacy work to ensure additional amendments. As a stakeholder, ECHAMP will continue to advocate its major concerns.

Pharmacovigilance

As regards pharmacovigilance, simplified registered homeopathic medicinal products (Article 14) are exempt from the obligation for Periodic Safety Update Reports (PSUR); however as the legislation stands at the moment, homeopathic medicinal products which have a national marketing authorisation (Article 16.2) will have to submit regular PSUR reports. This is a particular problem for those products which have been safely on the market for many years. ECHAMP will continue to advise MEPs of the need for a further amendments to allow these products an exemption.

An amendment on the reporting of non-serious suspected adverse reactions has been adopted; it intends to make all homeopathic medicinal products exempt from that obligation. However, this amendment needs further discussion because it does not differentiate correctly between those homeopathic medicinal products which are subject to marketing authorisation and those which are subject to registration.

In addition, a very difficult situation could occur if the following amendment (in bold) is adopted:

‘After the granting of a marketing authorisation, the Agency may require a marketing authorisation holder to conduct post-authorisation safety and efficacy studies, where important questions relating to the efficacy of a product remain or when scientific advances in the understanding of the disease or in the clinical methodology would significantly change previous efficacy evaluations. For this purpose the Commission shall provide guidelines’.

ECHAMP will need to make sure that homeopathic and anthroposophic medicinal products are exempt from this rule, which is in fact a renewal of the clinical aspect of the authorisation dossier. The tendency to give greater importance to a risk/benefit evaluation is also behind this accepted proposal.    

Counterfeit medicines

As regards the amendments voted for by the MEPs on the European Commission’s proposals on counterfeit medicines, the outcome has been quite positive for the industry for homeopathic and anthroposophic medicinal products. The hot topic of excipients has been amended in such a way that is acceptable for the industry, without imposing higher requirements than is currently the case. The assessment of excipients will be based on a risk-based approach and the creation of a list will be one of the concrete tasks of the European Commission in this respect.

So far, over the counter (OTC) medicines are exempt from the obligation to carry a safety feature. It is foreseen that the Commission will make a report (four years after the entry into force of this new legislation on counterfeit medicines) on the advisability of further extending the obligation to these products. Nevertheless marketing authorisation holders can already voluntarily put safety features on their products. However, this may not be the last word on this dossier: despite the voting by MEPs against safety features for OTC products, a large number of MEPs still insist on having safety features on all medicinal products on the market. Furthermore, the Council is in favour of safety features on all medicinal products that are at risk of being counterfeited. In this respect ECHAMP should support the original proposal of the Commission to limit safety features to prescription-only medicines.

ECHAMP intends to try and meet some key MEPs to find the best possible solutions for both items so as to ensure the bar is set at the right level (and not higher than needed) for the  patients and users of homeopathic and anthroposophic medicinal products.

Nand De Herdt
President of ECHAMP