Generic Medicines Day

EVENT REGISTRATION: Generic medicines – reducing costs and improving patient access to medicines in Ireland

Medicines for Ireland, the Irish pharmaceutical trade association and the supplier of the majority of medicines in Ireland, is proud to introduce Generic Medicines Day

 

It is well recognised by the HSE and the Department of Health that the increased use of generic medicines has delivered €1.6 billion in savings to the Irish health system since 2013. These savings have been delivered by the members of MFI who supply the majority of medicines to the HSE and to patients directly.

 

The important role of generics is set out in the Programme for Government which has commitments about reducing the cost of medicines, including via generic prescription. This is recognition from the Government that over the last decade, the increased use of generic medicines in Ireland has helped dramatically reduce the cost of everyday health care. These reductions have helped families across the county access a greater range of medicines due to generic competition. While this has resulted in the era of the big brand being dealt a blow, an increased use of generic medicines will help protect public finances and the HSE budget, with the possibility of redirecting savings into other much needed HSE resources.

 

Failure to address the high cost of medicines, with more sustainable generic options, will ensure that funding constraints remain a millstone around the neck of an already overstretched healthcare system. Generic medicines are central to the plans to continue to reduce costs while also improving patient access to medicines in Ireland. In the last 12 months, the average reimbursed price of generic medicines was six times less expensive when compared with non-generic medicines, illustrating the very significant savings that can be availed of at both national and local level.

 

Event:

Medicines for Ireland is delighted to invite members of the public to its first Generic Medicines Day event, a virtual conference with a range of excellent speakers and panellists as part of the inaugural Generic Medicines Day in Ireland. This conference is an opportunity to hear leading national and international experts discuss how generic medicines can contribute to reducing costs and improving patient access to medicines in Ireland. You can register for the event via the link below.

https://www.eventbrite.ie/e/generic-medicines-reducing-costs-and-improving-patient-access-to-medicine-tickets-153510781881


Filling the Gap: How off patent medicines can improve the equity and quality of cancer care”

We are pleased to publish our new report, ‘Filling the Gap: How off patent medicines can improve the equity and quality of cancer care” which has been produced in conjunction with our sister organisation, Medicines for Europe.

This report outlines a range of important national and European policy recommendations that illustrate the important role of generic, biosimilar and value-added medicines plays in ensuring equitable access to cancer care. This is especially the case in Ireland, where increased competition for resources within the Health Service Executive, means that smarter use of off-patent medicines can improve the equity and quality of cancer care for patients.

Availability of affordable off-patent cancer treatment is one of the greatest assets to efficient cancer care in Europe. They offer an opportunity to deliver on equitable patient access to the pharmaceutical standards of care and to better cancer care pathways. In Ireland, the Covid-19 pandemic has caused delays in cancer care that have been articulated by leading organisations such as the Irish Cancer Society.

We all know that cancer is one of the most burdensome health challenges of our time and while we have made incredible scientific advances in our understanding and treatment of cancer, there are gaps in equity of access to existing treatments. The generic, biosimilar and value-added medicines industries directly and indirectly contribute to tackling uneven access to preventive measures, screening and diagnostics, treatment and life-long care.

An important checklist of key policies that must be implemented to ensure equity and quality of cancer care is achieved has been established by Medicines for Europe. They are:

  • Finding synergies and sharing best practices
  • Comprehensive uptake policies for off-patent medicines
  • EU and national cancer strategies promoting the use of off-patent medicines.
  • Removing barriers after expiry of Intellectual Property (IP)
  • Adapting EU framework to develop value added medicines.

 


Brexit Impact on Imports and Exports of medicines and medical devices in Ireland

Question mark hangs over long term patient access to medicines due to import and export delays hitting the island of Ireland

Keeping an eye on trends impacting medicines supply to Irish families, Medicines for Ireland (MFI), the Irish pharmaceutical trade association and the supplier of the majority of medicine in Ireland to the HSE and patients directly, has published its most recent report, entitled Brexit Impact on Imports and Exports of medicines and medical devices in Ireland”.

According to Medicines for Ireland (MFI) Chairperson, David Delaney;

  • ‘’The good news however is that following continuous consultation with our members we don’t currently anticipate any issues with regard the supply of medicines in Ireland despite experiencing increase in demand.’’
  •  ‘’We are, however, concerned that the temporary nature of some of the current measures employed by the Government need to be addressed, as they are not sustainable moving forward and they threaten to undermine our ability to supply medicines to those who need them the most.” 
  • ‘’Further shocks to the supply chain, such as a new variant of Covid-19, could render the current patchwork Government policy inadequate to support our efforts in this regard.”

The report highlights the direct impact that Brexit has had on the imports and exports of medicines and medical devices in Ireland, with 90% of Medicines for Ireland member companies reporting delays in importing and exporting since January 1. All member companies are experiencing increased pressure on the supply chain, putting patient access to medicines in jeopardy on the island of Ireland, unless all stakeholders organise sustainable solutions quickly.

Speaking about the report, Medicines for Ireland (MFI) Chairperson David Delaney said, “let’s put on record our industry’s thanks for the hard work of officials in the Irish and UK public services leading up to the end of the Transition period. But we need to build on those temporary fixes now to overcome the considerable challenges for Medicines for Ireland (MFI) members who are on the front line of dealing with the impact of new trading routes and procedures and ensuring no impact for patients in relation to access to medicines. Some of the findings of the report speak for themselves and illustrate the direct impact that the new trading systems has had on imports and exports, with 56% of our members having experienced delays of up to 2-3 days, since the start of the year. Another 22% of companies have experienced delays of up to 5 days. Let’s also re-double our work with the logistics sector to ensure they continue to invest to make the new routes and systems work.”

“Nevertheless, our mission statement remains the same, to keep patients and their families front and centre of our efforts, and this report indicates that MFI member companies have reacted by changing distribution routes to ensure the continued supply of medicines (73% of respondents have had to change distribution routes into or out of Ireland since 1st January). This disruption to transport routes and changes from the impact of Covid-19 on business operations have led to increased pressures with 91% of respondents having experienced increased costs associated with importing and exporting.”

“MFI are continuing to work pro-actively with Government and key policy makers on aspects of policy to ensure round the clock continuity of supply in Ireland. We’re also communicating with the Department of Health and the Health Products Regulatory Authority (HPRA) as well as the HSE, EU Commission and all relevant EU institutions and officials North and South of the border to ensure a solution focused approach is taken to secure a stable supply of medicines to the Irish market.”

MFI member companies which include Accord Healthcare; Clonmel Healthcare; Consilient Health; Celltrion; Fannin; Fresenius-Kabi; Nasal Medical; Pinewood; Rowa; Teva and Viatris, contribute significantly to Ireland’s €40 billion annual pharmaceutical industry.

 


Generic and biosimilar medicines set to free up €1 billion in HSE resources over the next five years

Medicines for Ireland (MFI), the Irish pharmaceutical trade association and the supplier of the majority of medicines in Ireland, have launched ‘Reductions in the Cost of Medicines’, a report outlining how the Government can achieve a national saving of up to €1 billion over the next five years by switching to generic and biosimilar medicines. To put into context, €200 million of additional saving per annum could be redirected towards additional HSE resources, paying for 6,000 additional nurses or 3,500 extra nursing home beds.

Commenting on the report which was shared with Oireachtas members, Chair of Medicines for Ireland, David Delaney said: “It is well recognised by the HSE and the Department of Health that the increased use of generic medicines has delivered €1.6 billion in savings to the Irish health system since 2013. These savings have been delivered by the members of MFI who supply the majority of medicines to the HSE and to patients directly.

“Covid-19 has placed added pressure on an already over-stretched health system. The policy proposals set out in this report outline the opportunity for Government to free up significant HSE resources by avoiding an annual spend of hundreds of millions of euro on high cost patented medicines. Over the last decade, the increased use of generic medicines in Ireland has helped dramatically reduce the cost of everyday health care. These reductions have helped families across the county access a greater range of medicines due to generic competition. While this has resulted in the era of the big brand being dealt a blow, an increased use of generic and biosimilar medicines will help protect public finances and the HSE budget, with the possibility of redirecting savings into other much needed HSE resources.”

Mr Delaney added: “In the last 12 months the average reimbursed price of generic medicines was six times less expensive when compared with non-generic medicines, illustrating the very significant savings that can be availed of at both national and local level. Significantly, an increase in biosimilar medicines usage will lead to an increase in savings, greater patient access and better security of supply - thereby freeing money up for the funding of frontline services such as hospital beds as well as provide for much needed specialist staff.

“Failure to address the high cost of medicines, with more sustainable generic or biosimilar options, will ensure that funding constraints remain a millstone around the neck of an already overstretched healthcare system. The current penetration rate for biosimilars medicine in Ireland is below 50 per cent while the average across other EU countries is in the range of 80 – 90 per cent, demonstrating the immense opportunity for further savings in this area.

“Medicines for Ireland (MFI) members are at the forefront of national efforts to ensure that patients continue to access medicines despite the multitude of challenges that the Covid-19 pandemic introduced to the global medicine supply chain. This report is a result of a detailed analysis carried out by MFI to support its work and help stakeholders across Ireland optimally modernise public policy to ensure there is a sustainable supply of medicine to patients in Ireland. The result of all this equates to increased patient access to cost effective everyday medicines.”


Appointment of Mairead McGuinness as EU Commissioner a strong signal for Irish medicines and pharmaceutical sector

The appointment of Mairead McGuinness as EU Commissioner-designate for financial services and financial stability by EU Commission President Ursula von der Leyen is a very welcome development for the hugely important Irish medicines and pharmaceutical sector.

According to David Delaney, Chairperson of Medicines for Ireland, “the appointment of Mairead McGuinness to this hugely important role is very good news for the important medicines and pharmaceutical sector in Ireland. In her previous role as the First Vice-President of the European Parliament she has shown skill and determination in helping to ensure that the interests of Ireland have been protected at EU level. At Medicines for Ireland and through our parent organisation Medicines for Europe, we have engaged constructively with Mairead McGuinness throughout her time as an MEP. What has been remarkable has been her ability to influence policy and resolve very technical issues. Medicines for Ireland has worked with Mairead McGuinness since 2016 on the complex issue of Brexit in the context of ensuring that patients in Ireland are not impacted with the movement of medicines into Ireland. This crucial preparatory work for a ‘no trade deal’ Brexit has proven invaluable to Ireland in the context of the global Covid-19 pandemic.”

Photo via @EU_Commission


Lessons Learned from Covid-19

After several months of crisis, we can discern some of the key lessons learned from COVID-19 for the future of pharmaceutical policy in Europe. The COVID-19 outbreak in Europe has catalysed some long-standing issues in the functioning of pharmaceutical policy, as well as the impact this can have on patient access and hospital and pharmacy supply.

The off-patent medicines industry mobilised all efforts to ensure medicines continued to be developed, transported and supplied, in collaboration with the European Institutions, throughout the crisis. Our industry notably massively scaled up production and put in place cooperation mechanisms to tackle the colossal surge in demand for medicine.

Lessons learned

  • Manufacturing contingency plans enabled a dramatic increase in supply during COVID-19.
  • Government pandemic planning should exempt medicine manufacturing and logistics from lockdowns and other control measures.
  • Avoiding shortages during a pandemic requires industry coordination, demand visibility and close cooperation between governments/regulators and industry for regulatory flexibility.
  • EU and national coordination to ensure equitable supply of medicines is important for industry. Hoarding and other restrictions undermine our ability to supply patients in need.
  • Disruptions to global supply chains did not cause any critical shortages during COVID-19 because Europe has a robust medicines and API manufacturing sector. The sector should be strengthened to increase Europe's manufacturing competitiveness and resilience.
  • Repurposing of medicines was essential in securing treatment options in a crisis. A fit for purpose regulatory and market framework is needed to encourage future repurposing developments.

The full Policy Paper, detailing the lessons learned from COVID-19, is available to view here.


air freight medicines

Dedicated air freight hubs required across the EU to secure pharmaceutical supply chain

Medicines for Ireland (MFI), the Irish pharmaceutical trade association and the supplier of the majority of medicine in Ireland to the HSE and patients directly, has called for the creation of dedicated air freight hubs across the European Union (EU) to act as primary import and export points for medicines, active pharmaceutical ingredients, intermediates, key starting materials and medical equipment.

Commenting after a Dáil discussion on health and COVID-19, MFI chairperson, David Delaney said: “Pharmaceutical manufacturers rely on capacity in passenger flights to move medicines and ingredients rapidly and securely. With the spread of COVID-19, we’ve seen a dramatic reduction in passenger flights that normally carry pharmaceutical goods. We are recommending that EU authorities create dedicated air freight hubs to ensure there is enough capacity to cover the needs of the supply chain across Europe to mitigate the dramatic reduction of passenger flights.

“Similar provision is required in countries such as India and China which are major exporters of medicines to the EU and due to the global nature of the medicines supply chain, it is vital that an integrated international approach is taken to air freight for essential medicines. We’re asking the Irish Government and policy makers to proactively engage with their European counterparts to secure viable and affordable air freight access for medicines in and out of Europe.

“We’re continuing to work pro-actively with Government and key policy makers on aspects of policy to ensure round the clock continuity of supply in Ireland. We’re also communicating on   daily basis with the Department of Health and the Health Products Regulatory Authority (HPRA) as well as the HSE, EU Commission and all relevant EU institutions to ensure a solution focused approach is taken to secure a stable supply of medicines to the Irish market.”

MFI member companies which include Accord Healthcare; Aribamed; Clonmel Healthcare; Consilient Health; Fannin; Fresenius-Kabi; Mylan; Pinewood; Rowa; and Teva, contribute significantly to Ireland’s €40 billion annual pharmaceutical and device exports.

Mr Delany added: “Following continuous consultation with our members, we don’t currently anticipate any issues regarding the supply of medicines in Ireland as a result of the COVID-19 virus despite experiencing increase in demand. We very much welcome the measures the Government has taken to date to secure medicines supply, including the inclusion of pharmaceutical production and distribution in the list of essential services as well as the creation of virtual Green Lanes by the Revenue Commissioners to allow for a seamless flow of medicines in and out of the country. Such measures ensure that as an industry we are able to respond to this global health challenge.”

“It’s also important to recognise the significant lengths the staff personnel of our member companies are taking to keep all facilities operating at full capacity during this period. With great support from their families and employers, with increased protections and social distancing measures, they are working around the clock to maintain production and supply levels.”


Irish medicine supplies remain strong despite COVID-19

Medicines for Ireland (MFI), the Irish pharmaceutical trade association and the supplier of the majority of medicine in Ireland to the HSE and patients directly has confirmed while experiencing an increase in demand, its members don’t currently anticipate any issues with regard to the supply of medicines as a result of the COVID-19 virus.

Commenting, chairperson of Medicines for Ireland, David Delaney said: “Having consulted with all MFI members, we’re in a strong position to meet additional demands as a result of COVID-19. Our members have been working hard over the past number of years to ensure adequate stocks are in place as part of their Brexit planning and as a result there is little evidence to suggest that Ireland is likely to face general medicines supply issues. Irish consumers can be reassured that additional stocks of medicines are routinely built into the Irish supply chain, which will allow us to meet any increase in demand.”

MFI, which comprises of ten member companies employing over 5,000 staff across Ireland, is continuing to work directly with the Health Products Regulatory Authority (HPRA), community pharmacists, wholesalers, the Government, the Department of Health and other key stakeholders to address challenges arising from COVID-19.

Mr Delaney added: “I commend the Department, the HPRA and our members on their solution focused approach, which is significantly strengthening the stable supply of medicines to our friends, families and communities. I would like to congratulate the Government on its decision over the weekend to give critical pharmaceutical products Customs ‘green routing’ to facilitate uninterrupted importation and supply. Furthermore, we’re very grateful to the thousands of staff employed by MFI members all over Ireland, who are working around the clock to ensure continuity in the supply of medicines during this period, ensuring consumer access as well as maintaining a strong pharmaceutical export economy.

“As an organisation we will continue to work directly with the Government and all relevant State agencies to ensure that there is no disruption to supply of medicines. Because of the global nature of our industry MFI has welcomed the coordinated approach agreed by European Union leaders for the procurement of medicines, medical devices and protective equipment in light of the growing number of COVID-19 cases around Europe.

“It is important to emphasise that all stakeholders need to act responsibly, particularly those who procure stock and that they share contingency plans so MFI members can plan rather than react. For example, we are encouraging consumers to talk to their pharmacists and GPs and not to seek supplies of medicines over and above their normal requirements. Doing so will disrupt existing stock levels and hamper the supply of medicines for others.”


Medicines for Ireland welcomes EU coordinated approach on medicine supply as Covid-19 cases rise

Medicines for Ireland (MFI), the Irish pharmaceutical trade association, has welcomed the coordinated approach agreed by European Union leaders for the procurement of medicines, medical devices and protective equipment in light of the growing number of Covid-19 cases around Europe.

Commenting, chairperson of Medicines for Ireland, David Delaney said: “The focus by EU leaders to coordinate their public health responses better, including medicine supply, is hugely welcomed by the MFI members. As the coronavirus has no boundaries and is not restricted by boarders, it is important that not only a national, but a transnational approach is taken to ensure the continued supply of medicines and medical devices. This will help ensure patient access and should include joined up thinking by national Governments across Europe, European Union leaders and the EU Commission.”

The discussion around medicine supply formed part of wider emergency talks by European Union leaders via video conference yesterday, as they worked to coordinate a Europe-wide response to the coronavirus epidemic.

Mr Delaney continued: “As the supplier of the majority of medicine in Ireland to the HSE and patients directly, we welcome the coordinated approach led by the Department of Health. MFI is continuing to work directly with the Health Products Regulatory Authority (HPRA), community pharmacists, wholesalers, the Government, the Department of Health and other key stakeholders to address challenges arising from Covid-19. Our members are committed to working within their own companies to ensure stability of supply to all patients and are engaged directly with the Government and State agencies to ensure continuity of supply for medicines to patients in Ireland. This remains the current twin-track focus for MFI.

“It’s important to emphasize that no medicine shortages currently impacting on the Irish market are a result of Covid-19. Irish consumers should be reassured that there will be a continuity of supply of medicines and should be encouraged to talk to their pharmacists and GPs, and not to seek supplies of medicines over and above their normal requirements.”


Irish patients missing out on affordable medicines as outdated purchasing systems resulting in State overpaying for many medicines

The Government continues to overspend millions on expensive big brand medicines despite the availability of more affordable, equally effective generic and biosimilar alternatives.

  • State losing out on €40 million in savings per annum on just two medicines
  • Ireland at bottom of European league table in access to affordable biologic medicines
  • Event speakers include Robert Watt, Sec. Gen. of Department of Public Expenditure; John Given, Chief Pharmacist at University College Hospital Galway; and Averil Power, Irish Cancer Society CEO
  • Medicines for Ireland will publish a set of solutions in its new manifesto, A Vision for Health.

Irish healthcare leaders will meet to discuss new strategies for medicine pricing and procurement reform at an event in Dublin on Wednesday. A key message will be that while Ireland is well behind our European neighbours in procuring the most affordable medicines, that immediate reform can reverse this position.

The event will also mark the publication of Medicines for Ireland’s new manifesto, A Vision for Health, which sets out clear and proven solutions s for medicines policy, pricing and procurement, including:

  • Fast-tracking the publication of the Government’s long-promised National Biosimilars Policy;
  • Developing a national supply and pricing agreement that creates a level playing field for all pharmaceutical companies;
  • Government quotas mandating minimum generic and biosimilar medicine usage;
  • Ensuring that the HSE’s procurement system prioritises use of the most cost-effective medicines;
  • Overhauling the HSE’s High-Tech Medicines Scheme, including a framework for interchangeability and expansion of medicines on the list; and
  • An information campaign to raise public understanding of their medication options, the development of medicines policies, and the impact of policy on pricing and supply.

Medicines for Ireland, which represents Ireland’s generic, biosimilar and value added medicines sector, believes that the Government’s lack of clear medicines policy is still too heavily dependent on expensive branded medicines limiting the HSE’s ability to procure more affordable drugs, thereby limiting patient access to other life-enhancing treatments and continuing the HSE’s unnecessarily high level of expenditure on medicines.

For example, the Government spends more than €450 million a year on branded biologic medicines, despite the widespread availability of more affordable but equally effective biosimilar alternatives.

Humira, a treatment for rheumatoid arthritis, costs the HSE over €120 million per annum. The patent for this medicine’s molecule, adalimumab, expired last October, opening the market to less expensive biosimilar alternatives. However, because of a lack of Government procurement policy, the uptake of a biosimilar alternative has been negligible, resulting in €25 million in missed savings each year.

In respect of generic medicines, there is also an issue in implementing reference pricing. Delays in implementing mandatory price reductions once the patent expires on a branded medicine is costing the Health Services millions each year. In the case of one branded inhaler, on which the State currently spends €30 million per annum, the failure to reduce the price of this medicine by 50% post patent expiry, as required under law, is costing taxpayers €15 million. There are many other similar examples.

A Vision for Health

Speakers at Wednesday’s event will include Robert Watt, the Secretary General of the Department of Public Expenditure; John Given, Chief Pharmacist at the University College Hospital Galway (who has successfully implemented a medicine cost saving programme); Averil Power, CEO of the Irish Cancer Society; and Owen McKeon, Chair of Medicines for Ireland and Country Manager at Mylan.

Commenting ahead of the event, Owen McKeon said:

“Ireland’s medicines budget is unsustainable. Our population is ageing and living longer, all of which is places huge pressures on our medicines bill. Yet, the Government continues to overspend millions on expensive big brand medicines despite the availability of more affordable, equally effective generic and biosimilar alternatives.

“Opting for generics and biosimilars provide a clear-cut way of containing the HSE’s medicines spend while ensuring the same quality of care for patients.

“This is not a revelation. The use of biosimilars, for example, is standard practice in the EU. The Government has itself acknowledged the benefits of biosimilar dispensing and committed, in 2017, to publishing a National Biosimilars Policy.

“Equally, in 2013 the Department of Health committed to using best value generics to ensure the greatest number of patients get timely access to medicines. Six years on, key aspects of this objective have yet to be implemented. As a result, the State continues to lose out on tens of millions of savings. Until further reforms are implemented, Irish patients will miss out on access to affordable medicines, with outdated purchasing systems resulting in the State continuing to overpay for many medicines”.