MEPs back Fake Medicines Directive

A new law to protect patients from fake medicines has been approved by the European Parliament.

It covers internet sales and paves the way for new safety and traceability measures on drug packaging.

The directive – which still requires approval from the EU Council of Ministers – also says European countries must establish recall systems preventing identified dangerous fakes from being supplied to patients, with alerts being sent across the EU.

An estimated that 1% of medicines sold in Europe through legal channels are fakes.

Portuguese MEP Marisa Matias said falsified medicines are ‘silent killers’, either because they do not work or because they contain harmful substances that could kill.

The initiative was adopted with 569 votes in favour, 12 against and 7 abstentions.

The 27 EU governments will now study the directive and they can make amendments before it becomes law. The final text will then be incorporated into the national laws of EU member states within two years.

According to Guy Villax, chief executive of Portuguese API manufacturer Hovione, the directive is a major step forward in reducing patient risk.

‘The industry has been arguing that the playing field is not level, and that regulators inspect on proximity and not risk causing unfair competition,’ he said.

For suppliers of APIs, the directive will mean that:

• Shipments of APIs imported into the EU will be accompanied by a statement from the health authorities of the country of origin that API manufacture was performed under EU/GMP (ICH/Q7) or at least an equivalent standard and was/is regularly inspected according to this standard.
• Non-EU countries can apply to be included in an official list of countries that are equivalent to the EU in terms of GMP standards inspections/enforcement and sanctions, which is being compiled. Audits of listed countries will be repeated every 3 years.
• The EU will regularly inspect GMP and regulatory compliance of all API manufacture within the EU, and may also inspect European API traders and manufacturers of excipients
• Manufacturers, importers and traders of APIs, located in the EU, shall register their activities with their national health authorities
• Regular on-site GMP auditing of API manufacturers and of any involved API traders by dosage form manufacturers (or by a third party) becomes mandatory
• APIs to be exported from the EU should also be GMP compliant
• API sites that have passed European inspections and have received a European GMP Certificate are already available in a public EU database
• Severe penalties will be applied for any API falsification activities.

Villax said another major step forward in terms of compliance and transparency is the public availability of the European Medicines Agency’s EudraGMP database. This provides a complete list of all GMP certificates issued by any EU agency in the last 3 years anywhere in the world.

Certificates for both finished dosage forms and APIs are covered, addressing separately commercial use from clinical trial purposes. The database allows individuals to quantify the EU GMP certificates that are currently valid for each site inspected by an EU agency in any particular country.

Villax says a number of other events make it clear that the issue of intentionally substandard medicines and APIs is no longer just a concern of the pharmaceutical industry. ABC’s 60 Minutes, for example, is making programmes on it, the US congress is discussing similar legislation, the Council of Europe's Medicrime Convention is now a reality, and think-tanks such as Chatham House in London and the Council of Foreign Relations in New York are debating the issue.

A Pew Trust report will be announced on 14 March, which will provides details of all known API GMP fraud cases and recommendations on what should be done. Copies will be available from Hovione.

The issue of sub-standard food and medicines and the need for regulators globally to collaborate is also likely to end up in the G-20 agenda next year, said Villax.