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HPRA Stakeholder Brexit Event Update 2017-09-28

HPRA Stakeholder Event Update

Meeting: 31st August 2017

Meeting update is provided by Nicholas Littlebury, Deputy Managing Director of Diamond BioPharm Limited. The meeting update is provided based on the authors summary interpretation only and is not necessarily representative of the views of Diamond BioPharm Limited or wider industry.

On the 31st August the Irish Healthcare Products Regulatory Agency (HPRA), formerly the Irish Medicines Board (IMB) held an open stakeholder meeting to discuss the potential impact of Brexit with industry and associated organisations including speakers from:

  • Medicines for Europe
  • IPHA
  • Biopharmachem Ireland
  • Medicines for Ireland
  • APHA
  • IDA
  • IBEC
  • IPHA

The meeting date was timely as it occurred soon after the release of the UK ‘Continuity in the availability of goods for the EU and UK’ position paper1. The tone of the UK government position paper appeared to be in contrast to previous European Medicines Agency (EMA)2 & CMDh notice3 correspondence and associated Q&A4.

The meeting began in earnest with Lorraine Nolan, Chief Executive of the HPRA welcoming industry and associated organisations. Lorraine informed industry that the Irish government was fully behind the countries European Medicines Agency (EMA) bid and that regardless of of the EMA location, the HPRA would be increasing capacity in the coming months and years due to the likely increase in their European workload following Brexit. The HPRA’s theme during the meeting was that of ‘pragmatism’ to ensure opportunities for Ireland and a strong relationship with the UK and Medicines and Healthcare Products Regulatory Agency (MHRA) post Brexit.

Sergio Napolitano, Director for legal and External Affairs, Medicines for Europe (a medicines group for generics working between the EU and UK) spoke candidly about the current expected legal position following discussions with both EU and UK representative bodies. Following those discussions, Sergio was clear, that in his opinion the UK would become a third country. In a best-case scenario, this could include a Mutual Recognition Agreement (MRA). Sergio mentioned that much of the detail is still to be worked out on a technical level but a long transition period is likely inevitable.

Loretto Callaghan speaking on behalf of the Irish Pharmaceutical Healthcare Associations (IPHA) Regulatory Affairs Advisory forum spoke about the challenges faced by industry and welcomed the openness of the HPRA to discuss industry needs. Planning was stated as critical due to the potentially long lead times faced by industry in transferring licenses, supply chain impacts and staff EU location requirements for key roles such as QPPV and QP in pharmacovigilance and compliance respectively. Loretto also called for a critical list of products to be drawn up by industry and ratified by HPRA to enable continuity of supply for patients for the most important medicines. Continuity of access to medicines was a major theme running across speakers and industry throughout the day.

Sandra Gannon speaking on behalf of Medicines for Ireland shared several industry concerns to ensure that the HPRA was aware of potential issues ahead of time. Sandra discussed industry concerns around shared UK/IE packaging in medicines. At present, there is often a common pack used for products across UK and Ireland. This may not be the case in the future if the UK becomes a third country with separate regulations and legislation. Any requirement for separate packaging for Ireland and separate packaging for the United Kingdom is likely to increase costs significantly for certain medicines. To save costs companies tend to manufacture one large batch to share between UK and Ireland (traditionally proportionally more to the UK on average) and this will may no longer be viable.

Matt Moran, director of Biopharmchem Ireland, spoke about the manufacturing supply chain. The key ingredient being the level of UK exposure in a company’s supply chain for any given product. The more exposure, potentially the greater risk. Companies with UK exposure are already undertaking preliminary discussions with Ireland supply chain sites (quality control, batch release etc) with a large increase in enquiries post Brexit. Matt also discussed the potential impact on the unitary patent process and the possible impact of a UK exit and patent protection for products. This is still largely an unknown entity at present. The legal and procedural ramifications of the European Directorate for the Quality of Medicines (EDQM) Certification of European Products (CEP) process for existing and new certificates going forward without the UK would also potentially have a very large impact on pharmaceutical company supply chains. Matt raised the impact on research and talent sharing as the UK and Ireland are often joint beneficiaries in EU funding. Lastly Matt mentioned that the UK could become an aggressive competitor to Ireland in an uncertain political landscape and Ireland should continue to work on becoming a ‘go to’ place to do business in its own right.

Eugene Smith, Chairman of the Animal and Plant Health Association (APHA) spoke candidly about the industries concerns over future animal welfare. The UK acts as a reference member state in over 30% of EU license registrations. Of these applications, many lists just one other concerned member state; Ireland. Of these UK/IE EU applications, 75% have joint/shared packs with the UK by far on average being the largest market. Should pack sharing not be allowed or IE not considered with the UK in EU procedures then there is real market concern over continuity of supply with a directimpact on animal welfare. This could include reduced choice or absence of core medicines. Eugene also mentioned that the industry has many shared platforms with the UK and uncertainty over this could lead to further difficulties with animal welfare. The APHA welcomes a ‘soft’ Brexit and stated throughout that animal welfare is critical in the decision-making process and for Ireland.

Tommy Fanning, Head of BioPharm and Food for the Industrial Development Authority (IDA) responsible for the attraction and of foreign direct investment in Ireland spoke positively about Ireland as a place to do business. Tommy said that many companies continue to invest in Ireland, that the regulatory environment is second to none and that there have been many enquiries regarding the UK supply chain exposure and possibility of Irish businesses bridging this gap in the future if required with a 400% increase in enquiries in the last six months alone. The theme of the discussion was very much that Ireland is open for business and should grasp the opportunities associated with Brexit.

Arnold Dillon, Brexit Campaign lead, Irish Business & Employers Confederation (IBEC) discussed the requirements and considerations of Irish business now and post Brexit. There is a new cost pressure for Irish licenses due to the fall in the pound. Irish business and government should ensure current and future tax competitiveness compared to the UK with a potential need to reinvent the economic model to ensure Ireland is best positioned. Arnold also stated that significant transitional arrangements would be needed. Ireland remains a great place to live and work and companies should ensure this remains the case in the future.

Rita Purcell speaking on behalf of the HPRA said that uncertainty can be a worry and that there are three possible options. A third country arrangement for UK with or without transitional arrangements, a possible carve out (which is thought unlikely) or business as usual with the UK being a third country and the HPRA already having established procedures for dealing with third countries. Rita said that the HPRA is a gateway to Europe but industry has so far been quite silent with planning. Due to uncertainty, many companies were still using the UK Medicines and Healthcare Regulatory Agency (MHRA) as reference member state for procedures up until March this year. More feedback is required from industry and a two-way communication channel is important between regulators and industry. The HPRA confirmed that they will be pragmatic where regulation allows with regard to pack sharing/batch sharing solutions. The HPRA confirmed they would be happy to take on the role of RMS where Ireland is a CMS for within a European procedure and will not charge a fee for this service. Finally, the HPRA stated that the MHRA is a trusted regulatory partner with reference to an ongoing project on closer collaboration with third parties initiated even prior to Brexit. There is a strong commonality and history with the UK and the HPRA believes it will be a strong partner in dealing with Brexit. 

Links:

  1. https://www.gov.uk/government/publications/continuity-in-the-availability-of-goods-for-the-eu-and-the-uk-position-paper
  2. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500226603.pdf
  3. http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/BREXIT/CMDh_360_2017.pdf
  4. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500228739.pdf
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