Medicines Authority should NOT be part of new consumer affairs body

The Kamra ta’ l-Ispizjara ta’ Malta/Malta Chamber of Pharmacists expresses its surprise and serious concerns at the declarations in parliament by the opposition spokesman on Consumer protection, Hon. Silvio Parnis and Opposition spokesman on health, Hon. Anthony Zammit calling for the inclusion of the Medicines Authority to be part of the new Malta Competition and Consumers Affairs Authority, during the debate on the Bill proposing the setting up of latter, as reported in the Times, dated Thursday 20 January and Wednesday 26 January 2011, respectively.

The Chamber had participated consistently and proactively in the legislative developments which brought about the enactment of the Medicines Act, which came into effect in 2003, in the run up to Malta’s EU membership in 2004.

The Medicines Act 2003 provided for the establishment of an autonomous Medicines Authority to regulate medicinal products and pharmaceutical activities, on the premise that medicines are not ordinary items of commerce and pharmaceutical activities include the practices of health care professionals.

This Chamber reiterates that it has always expressed itself with no unsure terms on the significance of Pharmacy, Pharmacists, medicines, and health to Maltese society; and has, through its representations in connection with the enactment of the Medicines Act , striven to ensure that the legislation providing for the Medicines Authority should be robust, guaranteeing its autonomy – financial, administrative and professional.
The Medicines Authority is not only concerned with the registration of medicines, to ensure their quality, efficacy and safety, which is a significant feat in itself requiring by its very nature full autonomy. In fact, the Medicines Authority regulates the activities of the whole pharmaceutical sector and the pharmacy profession.

It has developed into a credible institution, nationally and internationally, importantly at European Union level. This credibility has been attained through the professionalism and expertise of the pharmacists practising at the Medicines Authority. It has undoubtedly also been attained through the implementation of the Medicines Act as enacted. Moreover, it is very important that this credibility has been attained, in view of the registration needs of Malta’s rapidly developing export-oriented pharmaceutical industry, which is such an important asset to our economy.

On the EU level, the Chamber independently and through its affiliation in the Pharmaceutical Group of the European Union (PGEU) supported the thrusts to retain pharmacy and health care services out of the scope of the Services Directive. Indeed, in the context of the EU, the present proposal would also go in the opposing direction of the recent widely acclaimed and welcomed updating of the EU Commission’s Commissioners’ portfolios. This moved medicinal products for human use from DG Enterprise to DG SANCO (Section C8 Under Public Health and Risk Assessment).

In the Chamber’s opinion, this move, if the Bill is amended to include the Medicines Authority, is a regressive one. Moreover the regulation of the Pharmacy profession should not be lumped in what appears prima facie to be a conflicting situation in this regard with consumer affairs, competition, etc where there is also provision for an Appeals tribunal. This, when the consumer already has means of redress through the statutory Pharmacy Council and the Civil Courts. This would introduce a possibly anomalous situation of triple jeopardy.

The Chamber insists that the Hon. Members of the Opposition consider to leave the Medicines Authority out of the new ‘Consumers Affairs body’ in the best interest of public health and consumer protection.