Impact of decision to move European Medicines Agency to Amsterdam

As one of many consequences of Brexit, following a very close vote by member states on Monday 20th November, Amsterdam has been confirmed as the new home for the European Medicines Agency. On current plans, the EMA will be operating in Amsterdam from April 2019, following a likely shadow hosting of the EMA there for some months before the formal date for completing the move of the agency.

The EMA's Patients and Consumers Working Party annual meeting

Meantime the EMA's Patients and Consumers Working Party (PCWP) is holding its annual meeting with all EMA eligible patient/consumer consumer organisations to consider relocation preparedness, patient and consumer involvement in EMA activities, highlights from major EMA committees and updates on pharmacovigilance, information on medicines and future work programmes in 2018 and 2019 for the PCWP and the EMA's Healthcare Professionals Working Party.

Effective medicines have both powerful therapeutic actions as well as the potential for serious unwanted adverse effects. The EMA was founded in 1995 with initial funding from the European Union and the pharmaceutical industry, and further support from EU member states. The European Medicines Agency is concerned with regulation, supply chain and pharmacovigilance for medicines and other advanced therapies for 28 countries across the European Union - from the Baltic countries to Ireland and from Scandinavia to the Balkans and the Mediterranean. All these roles concern balancing benefits and risks when it comes to patient safety with regard to medicines.

The EMA has established mechanisms for involving patients in regulatory assessment: patients’ value perception and value systems. The EMA also has an increasing remit to engage with stakeholder organisations and to improve transparency in its activities for the ~510 million citizens of the European Union. Furthermore the EMA has a major role in educating patients, carers and health care professionals about medicines. There have for example been recent workshops on

• combating antibiotic resistance: a partnership with the European Centre for Disease Control 
• biosimilars
• personalised medicine initiatives
• applying big data to improved regulation of medicines in Europe which raises important questions about clinical utility, quality, accessibility and systems for data mining

There remain many decisions and actions for the coming months needed to ensure continuity of the EMA's business. These involve the smooth relocation of the EMA to Amsterdam and either developing systems to retain UK expertise for the EMA or replacing that expertise from other EU member states. For the EMA, priorities include:

• minimising the impact on staff of the move to maximise staff retention
• maintaining capacity to continue the work of the EMA 
• the resulting need to prioritise EMA core and planned further activities
• continuing productive engagement with stakeholder groups: patients, carers, healthcare professionals ...
• maintaining the capacity of the EMA to engage with the public

For the UK, there are pressing questions regarding the future regulation of medicines in the UK post-Brexit, the impact of loss of international influence of UK regulators and other experts on medicines and the impact of loss of biotech and pharmaceutical companies from London to Amsterdam.

The EMA has been based in London for over 20 years. Many staff have strong family and other personal ties in the UK - for example partners' work, children at school, dependent relatives ...  Adapting to a new country is no simple matter. The working language of the EMA is currently English however full integration within Amsterdam will need competency in the native language in the Netherlands. There will also be practical challenges arising from the simultaneous impact of the arrival of up to 800 families on the Amsterdam housing market and schools system.

© Donald Singer 

US - European perspectives on potential impact of promoting cycling

As a response to my summer notes on 'city cycling', I was sent a link by @jenicarhee to a graphic (see below) on potential impact of regional schemes to promote cycling. Projected advantages include for health, environment and financial benefit. This approach lends itself to regular update on actual outcomes and imaginative ways to assess impact. See for yourself via: 'How bikes can save us [infographic]'.

City cycling: beyond the obvious benefits

Cycling sounds an attractive approach to better personal health, reduced carbon footprint and therefore a generally healthier urban environment. Rojas-Rueda and colleagues in a British Medical Journal paper have recently modeled the health risks and benefits of the Barcelona bike sharing scheme (Bicing), based on the over 180,000 Barcelona residents using the Bicing scheme.  They conclude there are greater health benefits than risks in Barcelona, and a large reduction in annual carbon dioxide emissions.
For Barcelona and elsewhere, bike-sharing appears to offer the opportunity to introduce regular cycling as a way for many in the population to return to, or increase exercise, on a sufficient scale for both public health and environmental benefits.
After Milan's earlier efforts to provide affordable and enjoyable city centre cycling - yellow bikes disappearing around Europe to Geneva and beyond - Paris (launched 2007) and London (launched July 2010) are also addressing the challenge of encouraging exercise and reducing car travel on city centre streets - with some extra effects on healthy mind and body. This includes 'water-cooler' bonding as initiates explain how to use the cycle pay columns or how to free a tricky bike. And more than intended exercise in several forms. Cyclists often need to return for a fresh hire after realising too late that their chosen cycle is faulty - punctured, chain off, saddle collapse syndrome, sticky wheels and so on (a Paris code is to reverse the saddle and or collapse the saddle support on a faulty bike); or moving from full cycle rack to next cycle station looking for a post at which to return a cycle at busier city locations. For the less pressed, this is another opportunity to meet fellow cyclists while waiting, and to compare notes on nearby velib station options. A peak time problem at busier sites is of course there being no bike available; more exercise, locating then walking to the next available station. Paris is trying hard - from the velib website at the end of August, 1233 locations were declared - enough hire and return capacity for this to be more than a tourist or freetime gimmick. The Paris website includes a colour-coded webmap: green for stations with available spaces, red for full cycle stations. The Paris Velib system leads the way globally in number of sites and available cycles. Paris also has the advantage of many wide pavements, and, in some areas, proper cycle lanes - although partnering these with buses and taxis is a source of recurrent adrenaline surge.
A reporting option on the booking terminal at cycle stations would be a good addition, so that the next hirer does not have the same problem; also helpful would be a less sticky webmap for locating alternative Velib stations: not a very mobile phone friendly website. And a review in Paris is planned of the economics of the scheme, with 80-90% of cycles reported in need of repair or replacement due to damage or theft; much less respected than the earlier  Lyon scheme (established May 2005, now with around 340 bike stations, and as for Paris, run as a partnership with advertising company JCDecaux).

© DRJ Singer