TheSocialMedwork is making a mission statement by its pledge to make medicines accessible to people around the world, at the same time, wherever they live.
The social enterprise and regulated medicines intermediary called TheSocialMedwork is offering new hope to patients concerned that Brexit could cause delays in essential drugs by using existing personal importation laws to access approved medicines which are not available in the UK.
The process of leaving the European Union could have profound consequences for health and the National Health Service. Doctors, NHS bosses and pharmaceutical companies have all warned that patients could face interruptions in access to medicines as a result of no-deal Brexit. But TheSocialMedwork has developed a system designed to help UK and EU patients overcome access issues perfectly legally.
Pharmaceutical companies, like AstraZeneca, have already publicly disclosed their concerns about the lack of clear processes between EU and UK regarding the manufacture, cross-border distribution and differing production controls of medicines. For patients undergoing treatment with imported, new, medicines for serious conditions these problems cause a real threat to health and successful treatment outcomes.
Working in accordance with the UK Government’s Medicines & Healthcare products Regulatory Agency (MHRA) TheSocialMedwork can legally help individual patients buy the latest innovative medicines without needing to travel to another country for treatment.
TheSocialMedwork has a new type of licence - the medicine intermediary licence which enables them to source medicines within the EU for personal use. This was created in Netherlands by law in 2012, from an EU directive and Dutch company TheSocialMedwork is said to be the first ever holder of this licence to help patients directly.
Typically, wholesalers, who currently act as the main suppliers of clinics, hospitals and other medical care providers, and pharmaceutical companies are not allowed to sell medicines to individuals and this is where TheSocialMedwork fills a gap in the market.
According to the Medicines & Healthcare products Regulatory Agency (MHRA) there is no requirement for a member of the public to notify them of the importation of medicines for serious or life-debilitating conditions on individual patient basis and does not restrict such importation.
Consequently, no licence, certificate or further authorisation is issued to or needed by recipients. The person receiving the medication needs to have only a prescription from a resident specialist and a doctor’s letter stating the name of the patient and the intended use and for how long the medicine supply will last.
The MHRA considers ‘individual patient use’ to involve the use of three-months supply of a medicine by an individual or family member.
TheSocialMedwork is a fully licensed, regulated medicines intermediary and social enterprise whose mission is to make newly developed medicines for serious and life-debilitating conditions available as soon as they are approved by the first authority.
It is the brainchild of Dutch entrepreneur Sjaak Vink (pictured), joined by Jamie Heywood (founder and chairman of the largest online patient community in the world - Patients Like Me) and Bernard Muller (co-founder of Project MinE and ALS patient himself).
Sjaak Vink said: “I've experienced first-hand the problems caused by delays in access to new medicines. With a Hard Brexit there is a chance that certain medicines may be unavailable, causing problems for patients undergoing treatments.
"This is when we can help, the founders have all experienced the impact of this and our pledge is to make new medicines accessible to all people around the world at the same time. We believe that health is the most critical human right, and this is something we’ll continue to champion.”
TheSocialMedwork sources medicines from GDP compliant suppliers across the world but tends to work with new medicines that hold the most value for patients. However, it can work to source any medicine (as long as it's not a generic) that a patient needs and cannot yet access in the UK on request.
A current topical example of this is the migraine prevention drug; erenumab (trade name Aimovig). Erenumab is not expected to be made available on the NHS until 2019, but patients can order today via TheSocialMedwork if they have a prescription from their doctor. The medication would be delivered in around 12 days. Other relevant UK examples include lumacaftor/ivacaftor (Orkambi) for cystic fibrosis and ocrelizumab (Ocrevus) for primary progressive multiple sclerosis.
The old process was very confusing for patients and their families, as they had to try to find a trustworthy supplier and then figure out what documentation is required for legal import, get a prescription and find a place that would administer the medicine and then organise the delivery themselves - often requiring specialist transport conditions such as refrigeration, or unbroken cold chain, which means ensuring the temperature never exceeds 3–8 degrees Celsius during the entire international delivery process.
TheSocialMedwork says it guarantees delivery in accordance with regulations and with the highest medical standards so that the patient, their family and the treating doctors can focus on medical care.
