The alarming increase in the falsification of medicines for human use in the Eurozone over the last several years has the national and European healthcare authorities against the wall. Conscious of the serious risk which this practice represents for consumers' health and the importance of having harmonised regulations, the European Union (EU) has approved measures to guarantee the reliability and safety of the legal supply of medicines in Europe. One of the most recent is Directive 2011/62/EU of the European Parliament and the Council, of June 8, 2011 (Directive 2011/62/EU), which amends Directive 2001/83/EC (of November 6, 2001, which established a Community-wide code for medicines for human use). In its preamble, Directive 2011/62/EU states patently that its spirit is to make the control of EU market access tougher. In order to do so, the European Parliament has concentrated on four different areas:

  1. reinforcement of the distribution channel;
  2. increase in control of the chain of production and the importation of active principles;
  3. detection of falsified medicines through the use of security devices; and
  4. increased control of the sale of medicines through the Internet.

This article analyses making the entrance of active principles for the manufacture of medicines for human use dependent on the manufacturer/importer complying with the requirements established in Directive 2011/62/EU.

Following its logic, first, Article 1.1 of Directive 2011/62/EU sets forth the scope of application of its measures, defining terms such as "active principle" and "falsified medicine". The questions-and-answers document prepared by the European Commission clarifies that Directive 2011/62/EU does not apply to active principles for veterinary use or for research, to "introduced" active principles, to active principles in imported finished medicines, or to imported active principles mixed with excipients.

Once the turf has been established, Directive 2011/62/EU introduces new measures to the current Community-wide code on medicines for human use.

Starting on July 2, 2013, when these regulations come into effect, active principles for the manufacture of medicines for human use may be imported only if they meet the following requirements. First, they must have been manufactured in accordance with rules of good manufacturing that are at least similar to those of the EU; that is, those of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Q7). Furthermore, pursuant to Article 46(2), the manufacturer of the finished product or the importer of the active principle must verify that the active principle comes with a written confirmation from the competent authority of the country of export (as determined by that country) that corroborates the following:

  1. the good-practice manufacturing standards for the active principle are equivalent to those used in the EU;
  2. there are periodic controls which are strict and transparent in the manufacturing facility in question and the good manufacturing practices are effectively applied, with repeated unannounced inspections; and
  3. on detecting a breach, the country will inform the European Medicines Agency. The written confirmation is necessary even if there is a "mutual acknowledgement agreement" between the country of the manufacturer and the EU.

Nevertheless, Article 46(3) establishes that the written confirmation will not be necessary if the country of export is included on the European Commission's list. The list will include a catalogue of those countries that, after the Commission evaluates each country's request, meet the requirements of the good manufacturing rules equivalent to those of the EU.

Directive 2011/62/EU provides that, in some cases, Member States may dispense with the above requirements. In effect, Article 46(4) provides that, in exceptional circumstances, if there is a need to guarantee the availability of medicines and one Member State has verified that a manufacturing facility for the active principle to be exported complies with the principles and guidelines of the EU's good manufacturing rules, any other Member State may then exempt the manufacturer from observing the above requirements, though it can only be for a period not longer than the validity of the certificate of the good practice rules.

Finally, these new regulations will have enormous impact for exporting countries that want to continue to market their active principles in the Eurozone. Thus, these countries must be included on the European Commission's list or have a written confirmation. To date, the countries which have submitted applications to the European Commission are Switzerland, Japan, the United States, Israel, Australia, Singapore, and Brazil. Switzerland is the only country which has been satisfactorily evaluated and therefore included on the list. On the other hand, India, one of the largest exporters of active principles to the EU, has begun to move and has informed the European Commission what agency will issue its written confirmation.