Falsified medicines – a threat to patient safety
The term falsified medicines in EU policy refers to fake medicines that are designed to mimic real, authorised medicines. Falsified medicines might contain ingredients, including active ingredients, which are of bad quality or in the wrong dose. This is distinct from counterfeit medicines, which refers to medicines that do not comply with EU law on intellectual and industrial property rights (such as registered trademarks or patent rights). The EU Directive on falsified medicines does not deal with counterfeiting. However, for the patient community these terms can be confusing as they are often used interchangeably.
Falsified medicines present a threat for patients in particular as they:
• do not contain the proper active ingredient in the proper quantity result in the patient’s condition being untreated or sub-optimally treated.
• may contain toxic materials that result in the patient being poisoned. Treatment with such medicines will have fatal consequences for patients.
A Commissions survey amongst Member States’ competent authorities conducted in spring 2007 showed that falsifiers are increasingly targeting the licensed distribution chain, including authorised wholesalers, parallel traders and pharmacies. Thus it is important to maximize the protection of the legal supply chain in the EU against infiltration of falsified medicinal products. Patients need to be sure that the medicines they consume are what they expect them to be. Therefore EPF welcomes the new legislation. It is essential to prevent these medicines from reaching the patients by introducing harmonised, pan-European safety and control measures.
Risks of internet sales
Another issue from a patient’s perspective is Internet sales. It is a major source for falsified medicines and there are a number of concerns regarding Internet pharmacies:
• the declared physical locations of online pharmacies are often false,
• There is evidence of great discordance between the domain of registration, compared with physical and delivery location,
• Often they do not ask for a medical prescription, and sometimes advertise on the fact that there is no need to see a doctor to get the drug
• Many online pharmacies did not publish information about side effects,
• Concerns around the drugs storage and shipping conditions, fraudulent and dangerous practices.
Member States can decide whether to make Internet sales legal, and for which kind of medicines, but there are no common safety standards. As patient representatives we are worried that internet sales could perpetuate the issue of counterfeiting, as currently patients are not enabled to distinguish trustworthy legal online pharmacies from illegal ones.
Patients have various reasons to buy medicines online: Some patients with chronic diseases, immobile patients, and patients requiring care in the home, older people, working people, and those living a long way from the nearest pharmacy may find it difficult to collect medicines from public pharmacies; therefore online pharmacies can provide another avenue.
But we must remember that while this may seem convenient there is a need to maintain, strengthen and not undermine the direct relationship between the patient, doctor and pharmacist within the supply chain of medicinal products. The relationship between patients and health professionals should always remain the starting point. Patients should be educated that they need to go to a healthcare professional when considering purchasing a medicine from the internet.
Falsified medicines are a major international problem. The European Patient Forum (of which Fighting Blindness is a member representing Retina International on its Board) has worked closely with IAPO – the International Alliance of Patient Organisations – to develop a position and advocate towards the EU institutions. IAPO has extensive experience of dealing with falsification issues at the international level.
Some key points stressed by EPF and IAPO are:
1. All strategies developed to combat falsified medicines should be in line with the principles of patient-centred healthcare: they can only be effective with the involvement of patients and patient organisations.
2. This also means considering the impact of these strategies on the patients in terms of access to safe, quality and appropriate treatments and information.
3. In particular, communication to patients on falsified medicines and internet sales is essential, and patient organisations should be engaged to communicate messages to the patient communities which they know well.
4. We have also called for a quality label in order to enable the public to recognise trustworthy online pharmacies.
5. We insisted that measures to combat counterfeiting should not lead to increased medicines prices for the patient.
6. We welcome the adoption of the Directive in July 2012 on Falsified medicine, as it takes major steps towards better oversight of the manufacturing and distribution chain.
7. We strongly advocate that effective communication to patients is also key for this strategy to succeed. Therefore we welcome all provisions that lead to better information to patients, including the common logo, the public websites that each Member State will need to put in place to inform patients about the risks of purchasing medicines online, and the national information campaigns.
Falsified Medicines Directive – a first step
The Directive of 2012 is a first step, but some key elements that were advocated for have not been fully integrated:
Regrettably the Directive does not clearly state that patient organisations must be involved in the information campaigns either at EU or national level.
Another issue is that not all non-prescription medicines will be required to bear safety features. Though we recognise the practical difficulties involved and the rationale for this, nevertheless all medicines are potentially at risk of being falsified, and there should be regular re-assessment of the risk of falsification.
As regard internet sales, the directive does not put in place a mechanism to report illegal online pharmacies.
Legislation is in our view one element in a multifaceted effort to tackle the issue of falsified medicines. A strong enforcement mechanism is also needed.
Close cooperation between stakeholders at the national and international levels is key to tackling falsified medicines.
Patient groups further recommends that the reasons why patients buy medicines online need to be studied and addressed through future measures to combat sales of falsified medicines on Internet.
Involving the patient community in implementation
Involvement of patient organisations is key for successful and effective public information campaigns, particularly to avoid causing panic and ensuring that patients do not stop taking their medication. Patient organisations should be involved to communicate messages to the patient communities and, in collaboration with health professionals, to empower patients to know their medicines, to assess their quality and provenance, to be vigilant for signs of counterfeiting and to report their concerns.
Member States are required to organise meetings with patient and consumer organisations in order to communicate public information about the actions taken in the area of prevention and enforcement to combat falsification of medicines. We encourage Member States to involve patient organisations meaningfully in their communication activities.
We have also identified other areas where patient organisations can provide input proactively in the implementation of this legislation, both at the European and national level.
Involving patients in the quality and safety of their medicines
Tackling falsified medicines and ensuring patient safety also requires a broader approach Patients play a key role in improving safety and quality of care: they offer the richest source of information, about shortcomings they witness during hospital stays and other experiences of the “patient journey”.
The falsified medicines legislation was adopted in synergy with the pharmacovigilance legislation, which empowers patients to report adverse drug reactions directly to the relevant authorities. Another key element is that patients need be empowered to play a role in ensuring safety of the medicines. There are three essential and complementary strategies towards empowerment:
1. The first one is high-quality, accessible information on health, diseases, therapy options… there is a need for an overarching strategy on information to patients to empower patients and citizens.
2. The second, related, element is health literacy, i.e. having the capacity to obtain, interpret and understand health information; to make sound health decisions; and to navigate the health services. Health literacy is a central strategy to empower patients and enable them to play an active role in their health and medical care.
3. Finally, a supportive healthcare environment is essential to achieve empowerment: The patient-professional relationship is crucial in the monitoring of the quality and safety of medicines. It is essential to implement patient-centred healthcare models where patients and professionals take shared decisions in partnership, and prescribing is based on concordance.
Falsified medicines is a serious threat to patients that we can only effectively tackle if all actors involved in manufacturing, distributing, prescribing and dispensing medicines are working together and cooperating at the national, European and international levels.
Patients are an essential part of the solution: they are willing and able to contribute both individually and collectively to improving the quality and safety of medicines in Europe. Their meaningful involvement in defining and implementing strategies to tackle falsified medicines is essential to ensure we address this threat fully and effectively.