Late last month, MEPs on the European Parliament committee responsible for health voted to include sales of pharmaceuticals over the internet in the European Commission’s draft directive on falsified medicines. With some surveys suggesting that more than 60% of drugs purchased online are fake, bringing internet sales under new mandatory safety rules for pharmaceuticals is aimed at reducing the supply of ‘potentially lethal’ fake medicines in the European Union. Read more »

A committee of the European Parliament voted yesterday to regulate online pharmacies to prevent falsified medicines from entering the legal supply chain. The committee agreed that the provision should be included in new draft EU legislation regarding falsified medicines and pharmacovigilance. Read more »

The European debate about combating counterfeit medicines is generating a lot of heat in Brussels as it comes to a head. In March the European Parliament is starting to tackle the detail of the European Commission’s proposal to stop falsified products getting into the legal supply chain – about the same time as officials from the EU member countries are nearing some sort of view on the technicalities. Read more »

When most of us look at taking a new medicine we tend to think it will make us better. Some of us may think about possible side effects but few of us expect the medicines we take to actually be dangerous. Recently, the public and policymakers have become more aware of the issue of counterfeit medicines — especially as patients increasingly learn about how to shop safely online for pharmaceuticals. But scant attention has been paid to a safety issue that is also important to patients — the problem of substandard medicines. Read more »

The Organization for Professionals in Regulatory Affairs (TOPRA) is a non-profit, non-political organization that seeks to advance the status of the regulatory profession through education and the provision of information to its members. Its members are drawn from industry, regulatory agencies and consultancies from over 40 countries. Pharm. Exec. Europe (PEE) spoke to TOPRA’s president-elect, Dr Zubair Hussain, head of regulatory affairs for Pfizer UK and Ireland, about what he sees as pharma’s key regulatory challenges for 2010 and beyond. Read more »

Technology is not the answer, at least not for tackling pharmaceutical counterfeiting. Instead, increasing criminal sanctions and encouraging relevant parties to work with “certified and reliable partners” are the real solutions. Read more »

The US Agency for International Development (USAID) and the US Pharmacopeial Convention (USP) recently announced a new program designed to fight the growing problem of substandard and counterfeit drugs in developing countries. Read more »

Last week, Alexis Pellek of Pharmaceutical Technology wrote about a pilot project launched by the European Federation of Pharmaceutical Industries and Associations to test a new system designed to battle counterfeit drugs (See the blog post.) The system involved using DataMatrix 2D barcodes, which enable pharmacists to test the legitimacy of each packet.

We spoke with Mark Beauchamp, European Marketing Manager of Citizens Systems Europe, a firm that specializes in barcode technology, to better understand how barcoding can help the pharmaceutical industry to clamp down on counterfeit drugs. Read more »

This week, the European Federation of Pharmaceutical Industries and
Associations (EFPIA) launched a two-month pilot project in Sweden designed to test a serialization and verification system in pharmacies that would fight counterfeit drugs. Read more »

Pharmaceutical brands face an increased threat online, according to a new report by the brand-protection firm MarkMonitor. The study, Brandjacking Index: Summer 2009, focused on six leading drug brands and examined these key areas of pharmaceutical brand abuse online: illicit pharmacies, listings on B2B exchange sites, and cybersquatting, or the abuse of a trademark within a domain name. Read more »