UK, EU medicines trade groups lobby Barnier, Davis for medicines alignment
Politico Europe,  Helen Collis, 12 July 2017

Eight life sciences trade associations from the United Kingdom and the European Union have hammered home the importance of maintaining ongoing cooperation between EU and UK authorities on medicines rules. The trade group, which includes ABPI, called for “as much certainty as possible, as soon as possible”. They also called for a reasonable implementation period, so that any changes arising from Brexit could be properly discussed and adhered to. They also expressed concern on the workload to be placed on regulators in the event of a wide divergence in regulatory frameworks between the UK and the EU.

Letter to Michael Barnier and David Davis
ABPI et al., 12 July 2017

The letter reported by Politico also included support for the letter signed by Jeremy Hunt and Greg Clark that appeared in the Financial Times and encourage a close relationship between EU and UK regulators. The trade group, which includes ABPI and the European Foundation of Pharmaceutical Industries and Associations (EFPIA), insisted that cooperation would be “in the best interest of public health and patient safety”. Further, they warned that any unnecessary disruptions would lead to “potential supply disruptions for life changing medicines”. They firmly placed the ball in the negotiators court, saying that “we are confident that, with your support, an agreement can be reached”.

‘The EU medicines scanning law convinced me we need Brexit’
Chemist and Druggist, John D’Arcy, 12 July 2017

In an opinion piece, John D’Arcy roundly criticized the falsified medicines directive (FMD) for failing to take into account the pecularities of national pharmaceutical networks and the slow pace of implementation. He notes that a scanner provider has not been appointed yet, despite the fact that scanning of medicines will be a cornerstone of the FMD. Because of the confusion, he argued that pharmacy is “nowhere near an understanding of how it will be able to fufill its obligations under the directive”. All in all, he said, the implementation of the FMD thus far has been a “dogs breakfast”, and implementation will be largely “incompatible with community pharmacy practice”.


There is no parliamentary coverage.


UK, EU medicines trade groups lobby Barnier, Davis for medicines alignment
Politico Europe,  Helen Collis, 12 July 2017

LONDON — Eight life sciences trade associations from the U.K. and Europe Wednesday wrote to the chief Brexit negotiators for the EU and U.K. to hammer home the importance of ongoing cooperation on medicines rules after March 2019.

Such an agreement would be the “best way” of ensuring that patients on both sides of the Channel maintain access to safe medicines and avoiding any harm to public health, they wrote, according to a copy viewed by POLITICO.

In the letter to David Davis and Michel Barnier, the trade groups acknowledge the phased approach to negotiations — leaving technical details like medicines regulations until after the divorce agreement has been settled — but stress the importance of setting out a position early given the “significant time pressure.”

They call for “as much certainty as possible, as early as possible” around pharmaceutical regulations and highlight the recent support by Health Secretary Jeremy Hunt and Business Secretary Greg Clark for regulatory cooperation.

Medicines marketing authorizations across the U.K. and Europe should stay in place after Brexit, they urge. They also call for a reasonable implementation period so the sector has time to adjust to the new framework, not to mention the added workload for EU regulators once U.K. experts are no longer helping out.

The letter’s signers include heads of the Association of the British Pharmaceutical Industry, the European Federation of Pharmaceutical Industries and Associations, EuropaBio, Medicines for Europe and others.

Letter to Michael Barnier and David Davis
ABPI et al., 12 July 2017

Dear Mr Barnier and Dear Secretary of State, We are writing to you as the associations representing the European and British pharmaceutical and life science industry (AESGP, EFPIA, EuropaBio, Medicines for Europe, ABPI, BGMA, BIA and PAGB) to underline the importance of securing ongoing cooperation between the UK and EU on medicines as part of the negotiations to agree a new relationship between the UK and the EU.

Securing such an agreement is the best way of ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines and to ensure that there is no adverse impact on public health.

We take note of the phased approach of the negotiations as agreed at your first meeting. However, we feel that it is important to set out our position at this early stage given the significant time pressure to ensure that the necessary arrangements are in place to secure patient access to medicines, and avoid any adverse impact on public health and patient safety in both the EU-27 and UK after the UK leaves the EU.

As you will be aware, our industry is highly integrated across Europe, and regulated under EU law through a sophisticated system of legal and regulatory arrangements between EU institutions, Member States and national competent authorities. It is important that there is as much certainty as possible, as early as possible, to enable the pharmaceutical and life science industry to transition smoothly into the new framework, ensuring there is no disruption to patient access to medicines.

The recent letter published by the UK Business Secretary, Greg Clark MP and the Health Secretary, Jeremy Hunt MP, signalled an opportunity to secure cooperation on the regulation of medicines as part of the negotiations. We would like to explore this possibility to maintain close regulatory ties between the EU and the UK and to begin these discussions immediately.

The maintenance of previously granted European marketing authorisations both in the UK and the EU, and the continued cooperation between national competent authorities as facilitated by the EMA and European Commission, will be important in achieving this. Similarly, any changes to the EU-UK trading relationship should not adversely affect the research, development, manufacture and supply of medicines across Europe, including for clinical trials.

Securing such a cooperation agreement would be in the best interest of public health and patient safety. The UK’s MHRA currently makes a significant contribution to the work of the  European regulatory network (EMA, HMA, CHMP, CMDh), and its withdrawal would mean a loss of capacity and expertise for the network for the review of medicines as well as the capacity across Europe for the surveillance and safety supervision of products. A capacity building exercise would be needed leading to duplication of assessment work at EU and national level. UK based Qualified Persons Responsible for Pharmacovigilance (QPPV) would need to be relocated, trained or replaced. This would have an overall impact on the running of the systems that ensure the safety and efficacy of medicines treating EU patients.

More importantly, in the case of an unorderly withdrawal there is a risk that all goods due to be moved between the UK and EU could be held either at border checks, in warehouses or manufacturing and/or subject to extensive retesting requirements. In fact, this would lead to a severe disruption of most companies’ supply chains, which would lead to potential supply disruptions of life-saving medicines.

Implementation period An implementation period that adequately reflects the time needed by pharmaceutical and biotech companies to transition to a new framework should be agreed on by negotiators. This will allow companies time to make the necessary arrangements to avoid any unintended consequences on the availability of the medicines that patient rely on, both in the UK and the EU-27. For example, pharmaceutical and biotech companies may need to submit applications for the transfer of marketing authorisation for specific products, move batch release for products or move personnel into the EU-27 from the UK, all of which would take a significant amount of time.

An implementation period will also be necessary for national competent authorities who need to ensure they are adequately resourced to deliver the procedures and maintenance activities associated with the new regulatory framework. We are confident that, with your support, an agreement can be reached which provides for an EU-UK partnership on the regulation and supply of medicines. Alongside an adequate implementation period, this will ensure that patients continue to have access medicines after 29 March 2019.

As stated above, our organisations are committed to a continued and open dialogue with you and your officials and are ready to contribute our expertise to the negotiations in order to ensure patients are able to continue to access the medicines they need, and avoid adverse impact on public health across Europe. We also continue to engage in constructive conversations with EU and UK regulators to ensure that there can be a successful transition to new arrangements as determined by the negotiations. A continuing role for the MHRA in the EMA’s committees and processes during this transition would be valuable for the continuity of the EMA’s operations.

We look forward to hearing from you and would very much welcome the opportunity to set up meetings with your services for in-depth discussions around our priority issues, given our sector’s technicality and complexity


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