Director General of the ABPI Dr Richard Barker said:
“This vote clears the way for concrete measures to help protect patients in Europe from counterfeit medicines which endanger the health and lives of patients. Implementation of the Directive will require the involvement of all key stakeholders – manufacturers, pharmacists and wholesalers but also patients – to ensure success. With their involvement in the design, implementation and running of systems, we can deliver the highest possible level of patient safety, the fastest rollout in member states at optimal possible cost.”
The vote follows months of intensive negotiations between the Parliament and Member States. The next step will be for the Council to approve formally the final text before it can come into force
One key element of the directive is the introduction of a pan-European system to provide unique serial numbers (such as two-dimensional bar codes) on each genuine medicine pack. This will allow pharmacists to check whether a pack with that serial number has previously been dispensed, alerting them to any risk of counterfeiting
The Directive also sets out provisions covering internet sales. The planned measures will protect patients purchasing online in those countries where it is legal to do so, and will better inform patients about the dangers of purchasing from illegal online sources. However, EFPIA remains convinced that a more comprehensive approach to illegal online sales of medicines is needed, and looks forward to further work in this area by the European Commission
This Directive allows for the introduction of several measures to secure pharmaceutical supply chains in Europe, from the original manufacturer to the dispensing pharmacy
The vote of the European Parliament is an important move in achieving greater protection for patients from counterfeit medicines
The next step will be for the Council to formally approve the final text before it can come into force
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About the ABPI
We represent innovative research-based biopharmaceutical companies, both large and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing 90 per cent of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
We are the Government recognised body negotiating the pricing of branded medicines on behalf of the entire industry. Working with our Research Affiliate Members, we promote the UK as a destination of choice for international life sciences investment.