To guarantee a high level of public health and to secure the availability of medicinal products to citizens across the European Union, all medicinal products for human use have to be authorised either at Member State or Community level before they can be placed on the EU market. Special rules exist for the authorisation of medicinal products for paediatric use, orphan medicines, traditional herbal medicines, vaccines and clinical trials.
Once a medicinal product has been authorised in the Union and placed on the market, its safety is monitored throughout its entire lifespan to ensure that, in the event of adverse reactions that present an unacceptable level of risk under normal conditions of use, it is rapidly withdrawn from the market. This is done through the EU system of pharmacovigilance.
Even though the rules on pharmacovigilance were improved in 2010, potential weaknesses were brought to light in 2011. Therefore, the Commission ran a "stress-test" of the rules and proposed further amendments to the legislation and new EU rules aimed at strengthening the existing legislation were agreed.
The new rules came into force at the end of 2013, leading to strengthened monitoring of additional categories of medicinal products. Patients and health professionals will recognise these medicines thanks to a standard black symbol, and an explanatory statement about the product's characteristics. That statement encourages all users to report suspected adverse reactions to these medicinal products. In addition, marketing authorisation holders are required to clearly justify all withdrawals, suspensions or non-renewals of the marketing authorisations, so that no product falls through the net and escapes scrutiny where safety concerns are identified.
On 7 March 2013, the European Commission adopted a new Regulation implementing these rules. The Regulation requires the introduction of an inverted black triangle to identify medicinal products subject to additional monitoring and from September 2013, the inverted black triangle has been used to identify the following pharmaceutical products:
- All medicinal products authorised after 1 January 2011 that contain a new active substance
- Biological medicinal products, such as vaccines or plasma derived products, authorised after 1 January 2011
- Products for which certain additional information is required post-authorisation, or for which authorisation is subject to conditions or restrictions on their safe and effective use.
Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. Falsified medicines might contain ingredients, including active ingredients, which are of bad quality or in the wrong dose and as such, are a major threat to public health.
New EU legislation on falsified medicines was adopted in Summer 2011. The new legislation introduced tougher rules to improve the protection of public health with new harmonised, pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. To this end, these new measures include:
- An obligatory authenticity feature on the outer packaging of the medicines;
- A common, EU-wide logo to identify legal online pharmacies. This would make it easier to distinguish between legal and illegal online pharmacies throughout the European Union (see below);
- Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and
- Strengthened record-keeping requirements for wholesale distributors
Following the adoption of this Directive, the European Commission worked on a number of implementing measures and ran consultations to this end. The NHS European Office engaged with this process, submitting responses to various consultations, making it clear that while it fully supports initiatives to safeguard the protection of patients, it is important that new measures do not interfere with effective dispensing procedures already in place in the NHS.
Safety features for medicinal products
As part of the implementation process of the Falsified Medicines Directive, on 9 February 2016 an EU Delegated Regulation laying down detailed rules for the safety features appearing on the packaging of medicinal products was published in the Official Journal of the EU.
The rules introduce a unique identifier system for medicinal products, which will allow drugs to be tracked from the manufacturer to the patient, and to identify whether any falsified drug has entered the European supply chain. Practically, they will require community and hospital pharmacies to conduct a verification of prescription medicinal products before they are dispensed to patients. This will be done through scanning each pack of medicine to verify the unique identifier and thus making sure that the drug is not falsified.
Given the significant implications for the NHS emerging from these rules, we engaged extensively with the European Commission when they were drafting the proposals, pushing for flexibility on when and how the verification is conducted.
We successfully made the case for certain healthcare professionals who dispense medicines to be exempted from the requirements in certain circumstances, and for hospital pharmacies to have flexibility to decide when to perform the verification scan, rather than be compelled to scan at the point of dispensing.
The UK, as the other member states of the EU, will have three years to ensure domestic implementation/compliance with the rules. We will engage with this process to ensure that the NHS can make the best possible use of the flexibilities in the rules on when and how the verification system is conducted.
Common logo for websites of legally-operating online pharmacies/retailers
On 24 June 2014, the European Commission adopted the common logo that will ensure the authenticity of medicines sold by on-line pharmacies and help protect patients from the possible harmful effects of falsified medicines. The logo links to the national regulatory authority’s website, where consumers can check if an on-line pharmacy is listed as an authorised retailer of a particular medicine. More details in the Commission's press release.