Medicines for Ireland are delighted to announce the publication of new Code of Practice

Medicines for Ireland are delighted to announce the publication of the MFI, Code of Practice V2.0. Which is now available on the Medicines for Ireland website:

https://www.medicinesforireland.ie/wp-content/uploads/2022/05/Medicines-for-Ireland-Code-of-Practice-V2.0.pdf

Medicines for Ireland are committed to ensure that all members advertising medicinal products aimed at both healthcare professionals and the public is conducted in a responsible, ethical, compliant and professional manner.

The Codes set out specific standards for pharmaceutical companies with regard to ethical and regulatory advertising, and promotional interactions with the Healthcare Community.

A sincere thanks to Sarah ONeill, Chairperson of the MFI Regulatory Affairs Sub-Committee for the leadership she has played in ensuring the publication of this updated Code of Practice.

 


Value Added Medicines: Advancing Medicines Repurposing in the EU report

PRESS RELEASE

5 May 2022

 

 

Value Added Medicines (VAMs) are medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients and healthcare professionals. VAMs are key drivers for access to medicines and are increasing patient quality of life for chronic diseases, while offering significant benefits to the healthcare community.

 

VAMs offer a wide range of benefits from ensuring better adherence and compliance, to keeping healthcare costs down by reducing the need for patients to be moved to expensive next line therapies. The importance of using VAMs to address unmet medical needs in a timely and cost-effective manner has been highlighted during the Covid 19 pandemic.

 

We are pleased to publish our new report focused on the benefits of using VAMs in an EU context. ‘Value Added Medicines: Advancing Medicine Repurposing in the EU’ builds on the 2021 published report ‘Discussion Document on the Contribution of Value Added Medicines (VAMs) in Ireland’. It has been produced in conjunction with our sister organisation, Medicines for Europe.

 

The 2022 report stresses that in order to make medicine repurposing a success on an EU level we need to employ all resources at hand to connect different actors. One such connection which can uniquely be addressed by the EU is to assist academia and non-commercial stakeholders in conducting research, as well as facilitating their partnering with the industry in making repurposed medicines available to patients.

 

The early involvement of industry in repurposing projects opens a range of opportunities like new indications, different/adjusted delivery forms, changing dosage and combining different therapies to meet the needs of the patient community and to bring to market new treatment options in an accessible and affordable way.

 

Furthermore, for more repurposing projects to come to fruition, we need to adapt the EU pharmaceutical ecosystem, starting with recognising the need for a tailored development approach for VAMs, including repurposed medicines. VAMs should be acknowledged as a separate group of medicines in EU legislation.

 

“Ireland can learn a lot from our EU peers. The industry needs to continually innovate, meanwhile, the state and regulators still have an important role to play,” said Padraic O’Brien, Chairperson of MFI. “We need a system that rewards innovation with appropriate incentives, whilst recognising the potential long-term value and savings that VAMs can bring to the State.”

 

“At MFI, we are committed to improving patient care and delivering value to the HSE and are proud to drive stakeholder engagement on this important topic,” said Clodagh Kevans, Chair of the MFI VAM Committee. “We believe that we need a new and simplified regulatory pathway for VAMs in Ireland, which would bring us into line with other major European countries to ensure that our patients and healthcare system is not left behind.”

 

“We also need a shift in mindset from one that focuses purely on cost to an outlook that is centred around better outcomes for patients taking a holistic look at the whole patient journey,” Kevans continued.

 

Read the 2022 Report here: https://www.medicinesforireland.ie/wp-content/uploads/2022/05/Value-Added-Medicines-Advancing-Medicines-Repurposing-in-the-EU-MFE-MFI-report-.pdf

 


EU ensures uninterrupted supply of medicines between Ireland and the UK

PRESS RELEASE

13th April 2022

 

EU ensures uninterrupted supply of medicines between Ireland and the UK

New measures ensure sustained supply of medicines from Great Britain to Ireland in light of challenges experienced post Brexit

 

Yesterday (12.04.2022), the European Union Council adopted two European Commission proposals to ensure legal certainty and predictability for the long-term supply of medicinal products and investigational medicinal products from the United Kingdom to Ireland, Northern Ireland, Cyprus and Malta. This follows a sizable majority vote in the European Parliament last week in favour of implementing these measures.

Commenting, Chairperson of Medicines for Ireland, Padraic O’Brien, said: “MFI welcomes the endorsement of measures to continue the supply of medicines from Great Britain to Northern Ireland, Cyprus, Ireland, and Malta, as proposed by the European Commission late last year. These new procedures will help to safeguard the supply of medicines across the island of Ireland, following challenges experienced post- Brexit.”

The exceptional provisions will allow medicines authorised in the UK to be supplied to Northern Ireland through a temporary authorisation, valid for a maximum of six months or until the European Medicines Agency grants or refuses a marketing authorisation in the EU. Specific conditions would be in place to ensure that UK-authorised medicines do not enter the EU single market.

In this context, marketing authorisation holders may be established and/or located in parts of the UK other than Northern Ireland and batch testing may be carried out in parts of the UK other than Northern Ireland. Additionally, investigational medicinal products manufactured in parts of the UK other than Northern Ireland can be imported into Cyprus, Ireland, Malta and Northern Ireland, provided that certain conditions are fulfilled.

David Delaney, Chairperson of the MFI, EU Affairs Committee said: “We are very pleased that the European Parliament and EU Council have decided to adopt these proposals, which will help to significantly diminish the risk posed by Brexit to the medicines supply chain across Ireland ensuring that patients have access to the medicines they need”

These derogations will apply indefinitely to Northern Ireland, while for Cyprus, Ireland and Malta the derogations will be temporary for a period of three years, as these markets are expected to gradually be supplied through EU member states. The measures adopted by member states will apply retroactively from 1 January 2022.

 


Call on EU leaders to safeguard access to medicines and build resilience in response to Russia-Ukraine war

The supply of medicines is critical yet unstable as war continues in Ukraine.

As a key medicines supplier, our sector is doing everything possible to support Ukrainians and welcomes the recent establishment of a more coordinated EU approach to the donation of medicines to Ukraine. We are also mobilising our logistical capabilities in close coordination with EU civil protection agencies, the Ukrainian Ministry of Health and NGOs supporting Ukrainian patients in this time of need.

Given the essential role of medicines in humanitarian situations and public health, special effort and protection is needed from European Heads of State and Government.  As EU leaders meet in Brussels to discuss the evolving response to the conflict in Ukraine, we urge targeted action to facilitate safe production and transportation of medicines.

Our highest priority is to secure humanitarian corridors inside Ukraine for the safe passage of civilians and for the delivery of medicines to war-stricken cities. We deplore the military attacks on stocks of life-saving medicine and are deeply concerned about the lack of medicine for Ukrainians in the war-torn regions. We therefore plead with the EU to use all diplomatic channels with Russia to establish these vital corridors.

The EU had no choice but to apply extraordinarily strong sanctions against Russia to stop the war in Ukraine. We appreciate that medicines have been exempted for humanitarian reasons and we are working with our members to help them to comply with these important rules, notably the financial and the logistical limitations imposed by the international sanctions. There is, understandably, pressure to increase sanctions against Russia. We would therefore advise a closer dialogue between the relevant EU enforcement bodies and the medicines industry on finding the correct balance between the humanitarian need to supply medicines and the EU’s legitimate sanction policy to stop the war.

We encourage the EU Council to devote its full energy and authority to stop the war in Ukraine and to protect patients by securing access to medicines, while taking the necessary action to support our industry in achieving the same goal.

https://www.medicinesforeurope.com/news/call-on-eu-leaders-to-safeguard-access-to-medicines-and-build-resilience-in-response-to-russia-ukraine-war/

Medicines for Europe
Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.

 

 


Statement on the War in Ukraine from Medicines for Europe

Medicines for Europe is highly concerned by the impact of the war in Ukraine on the supply of medicines to patients. The priority of Medicines for Europe members is to continue to ensure that patients in Ukraine and refugees arriving in EU Member States have access to the medicines and medical materials they need.

Access to life saving generic and biosimilar medicines via humanitarian corridors is and will be essential in the coming weeks and months. These should remain available to all patients regardless of where they may be and so must continue to be exempt from sanctions.

Medicines for Europe members are engaging with authorities and NGOs on the ground to secure the supply of medicines and medical supplies. Medicines for Europe is in contact with the Ukrainian government and companies operating in Ukraine to assess what medicines are needed and to request supply from our member companies. It is critical that corridors are open for the supply of medicines to Ukraine.

In parallel, Medicines for Europe is currently monitoring the European Union supply chain and any possible disruptions in collaboration with the European Medicines Agency.

We are committed to providing access to medicines on humanitarian grounds to all those in need.

 

Medicines for Europe
Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.

 

https://www.medicinesforeurope.com/news/statement-on-the-war-in-ukraine/

 


Padraic O’ Brien of Accord Healthcare and Paul Neill of Teva Pharmaceuticals appointed Chairperson and Vice Chairperson of Medicines for Ireland

Medicines for Ireland has announced the appointment of Managing Director of Accord Healthcare Ireland, Padraic O’Brien as new Chairperson of the organisation, with Paul Neill, Director of Generic Products for Teva Pharmaceuticals Ireland, taking over the role of Vice Chairperson.

Since its foundation in 2016, Medicines for Ireland has been promoting the benefits of the increased use of generic and biosimilar medicines in Ireland. The organisation’s core objective is to improve the way Ireland procures and supplies medicines, in order to expand the patient access to affordable, lifesaving and life-enhancing treatment.

Chairperson, Padraic O’Brien previously served as MFI Vice Chairperson in 2020 and 2021. Through MFI, he has been actively engaging with policy makers on both a national and European level with respect to increasing access of affordable medicines for patients, as well as highlighting the need for safeguarding measures to be putting place to help mitigate threats to the supply of medicines to Ireland brought about by Brexit and Covid-19.

Following his appointment to the role of Chairperson, Mr O’Brien stated “I am honoured to take over the role of Chairperson after a very successful year at MFI. Our strong contribution to the recent Framework Agreements on Pricing and Supply of Medicines 2021-2025 recently agreed with the Department of Health, the Department of Public Expenditure and Reform, and the HSE, is the culmination of two years of hard work from the MFI membership and in particular outgoing Chairperson, David Delaney.

This new Framework Agreement on the supply and pricing of non-originator, generic, biosimilar, and hybrid medicines announced by Minister for Health, Stephen Donnelly in mid-December is estimated to reduce the State spend on medicines by up to €700 million, while dramatically improving access to innovative new medicines for patients nationwide.”

Newly appointed Vice Chairperson, Paul Neill is Director of Generic Medicines for Teva Pharmaceuticals, the largest supplier of prescription medicines to the State and has experience working in the pharmaceutical sector for almost twenty years.

“As we look to the future, Medicines for Ireland will continue to engage with the Minister for Health, the Department of Health, the HSE and Government on key issues, especially on expanding access and usage of generic and biosimilar medicines. In Ireland, we continue to remain well below what is the norm in most other European States, and while much progress has been made, much more can be done in this area,” said Mr Neill.

Mr O’Brien concluded “I look forward to leading Medicines for Ireland on these issues ensuring that Ireland’s approach to medicines serves the best interests of patients, their healthcare professionals and the State.”

 

 


Framework Agreement on Supply and Pricing of Medicines 2021-2025

In December 2021, Medicines for Ireland (MFI) signed a new Framework Agreement on Supply and Pricing of Medicines 2021-2025 with the Department of Health, the Department of Public Expenditure and Reform, and with the Health Service Executive (HSE).

 

The text of the 'Framework Agreement on the supply and pricing of non-originator, generic, biosimilar, and hybrid medicines' can be viewed here.


Minister for Public Expenditure and Reform welcomed new Framework Agreements on Pricing and Supply of Medicines 2021-2025

22nd December 2021

The Minister for Public Expenditure and Reform Michael McGrath TD has “welcomed the substantial cost efficiencies that have been secured as part of two new Framework Agreements on Pricing and Supply of Medicines 2021 – 2025.”

 

“This Agreement maintains a focus on patients access and the best possible outcomes while also delivering value for money for the taxpayer.”

 

https://www.gov.ie/en/press-release/6b592-minister-mcgrath-welcomes-cost-efficiencies-of-in-excess-of-600m-in-new-agreement-on-pricing-and-supply-of-medicines/

 

 


Response to new Framework Agreement on Supply and Pricing of Medicines 2021-2025

Response from Medicines for Ireland (MFI) to new Framework Agreement on Supply and Pricing of Medicines 2021-2025

 

‘We welcome the new Supply and Pricing of Medicines Framework announced by Minister Donnelly. We believe, as the representative of the companies who supply the majority of medicines in Ireland daily, this agreement will bring increased patient access to generic and biosimilar medicines in Ireland, offering patients and healthcare professionals more choice, and yielding substantial savings to the State over the years ahead.’’

Padraic O’Brien, Chairperson, Medicines for Ireland

 

“This is a transformational agreement that will ensure even greater access to generic and biosimilar medicines in Ireland. The Minister, the HSE, the Department of Health and our member companies have worked tirelessly to make this new Agreement a reality, ensuring the focus remained on patient access to medicines. The Agreement is a positive step forward, bringing patients in Ireland earlier access to best value biosimilar and generic medicines in their patient journey.’’

David Delaney, Director, Medicines for Ireland.


Medicine Pricing Agreements a boost for patients and good news for Irish Pharma Sector

15th December 2021

Medicine Pricing Agreements a boost for patients and good news for Irish Pharma Sector – Tánaiste and Minister for Enterprise

 

Tánaiste and Minister for Enterprise, Trade and Employment, Leo Varadkar TD, has said two new agreements on the supply and price of medicines are very good news for the Irish pharmaceutical sector which employs thousands of people.

 

https://enterprise.gov.ie/en/News-And-Events/Department-News/2021/December/20211215c.html