Irish patients missing out on affordable medicines as outdated purchasing systems resulting in State overpaying for many medicines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

Promised reforms abandoned as State misses out on opportunity to save almost €140 million annually on medicine costs

Generics@5 Report

July 2018

View report

A representative body for Ireland’s largest medicine suppliers has warned that medicine costs for the HSE and patients will continue to increase over the period ahead unless further reforms are prioritised.

Medicines for Ireland (MFI), the representative body for the generics, biosimilar and value-added industry, whose members are the largest supplier of medicines to the HSE, has cautioned that the Government’s failure to reform key areas of our medicines market is resulting in increased medicine costs and leading the State to lose out on savings of at least €138 million annually.

MFI today, (Thursday, 12 July) published its new policy document — ‘Generics@5 – Affordable, Accessible for All’—which marks five years since the introduction of generic substitution and reference pricing in 2013.

At that time, the Health (Pricing and Supply of Medical Goods) Act 2013 changed Irish law to make it mandatory for pharmacists to substitute costlier branded medicines for more affordable generic medicines, in most cases, once the medicine’s patent protection had fallen.

The Act, for the first time, allowed both the HSE and private patients to opt for equally effective but more affordable generic alternatives.

Key achievements derived from generic substitution over the period have included:

  • €1.6 billion in savings delivered to the Irish State since 2013
  • The average wholesale price per pack of medicines has fallen from €18 in 2012 to €6 by 2018
  • For example, overall spend on Ireland’s most used medicine, statins—used to lower cholesterol—has fallen from €160 million to €36 million per annum

While the 2013 Act delivered significant savings to the Exchequer, our health service and patients, MFI in its policy document warns that this flow of savings is now at an end. MFI asserts that the failure of the Minister for Health to continue this programme of reforms beyond the 2013 Act has meant that medicine spend in areas such as the High-Tech Scheme have accelerated rapidly in recent years. For example, spend on this scheme has almost doubled from €337 million in 2009 to €662 million in 2017.

The lack of focus on further reforms comes at a time, when the HSE faces a potential budget overrun of €600 million by end 2018.

“Our population is ageing. Despite living longer, we are now impacted by a greater incidence of chronic disease. That brings with it an increased need for medicines—but sadly, today, access to them is no longer guaranteed,” said Owen McKeon, Chairperson of Medicines for Ireland and Country Manager of Mylan.

“The challenge for our Government now is how to maintain affordable access in the years ahead.  The priority has to be to continue to reform,” he said.

MFI has set out a number of immediate reform proposals, which it estimates can deliver almost €140 million in savings per annum. These include:

  • A new National Medicine Pricing Agreement with the generics industry to drive further reforms;
  • Increasing competition in Ireland’s medicine market, particularly in the low-volume, low value medicines market, which would deliver at least €75 million in savings;
  • Immediate publication of a National Biosimilar Strategy, which was first promised in February 2017 and which has the potential to deliver €25 million in savings;
  • Changing existing legislation to provide all new patients with generic medicines would yield €18 million in savings;
  • Reform of the High-Tech Scheme to provide €20 million in savings.

Mr. McKeon further added: “Today’s policy document shows that when reforms such as generic substitution were implemented in 2013, they yielded €1.6 billion in savings for our healthcare system and patients.

“Since then, the pace of reform has stalled and our medicine spend is now beginning to escalate again. Just one example of how to stop this upward trajectory is a National Biosimilar Strategy. This would stimulate increased uptake of more affordable biosimilar medicines. Unfortunately, it has now been delayed by the Minister for Health for over a year.

“The lack of a dynamic and competitive medicines market in Ireland, threatens not only the State’s capacity to meet patient needs, but also undermines continuity of supply. Medicines for Ireland is calling on the Minister for Health to implement our proposals to safeguard patient well-being.”

Urgent reforms needed to prevent increased medicine shortages post-Brexit, according to leading pharma body

As healthcare stakeholders gather together today (Monday) as part of a Health Products Regulatory Authority (HPRA) initiative to develop solutions to the growing problem of medicine shortages in the Irish market, a leading pharm body has warned that unless urgent reforms are introduced the problem will worsen post-Brexit.

Medicines for Ireland, the representative body for the generic medicine industry in Ireland, voiced its concerns that medicines shortages which have been growing in Ireland are likely to increase further once the UK leaves the EU.

Currently there are over 120 medicines which are out of stock. These medicines cover a wide range of conditions, which impact upon tens of thousands of Irish patients, including asthma, thyroid conditions, oral contraception, angina and schizophrenia.

Medicines shortages have become a growing feature of the Irish healthcare landscape in recent years, prompting bodies such as the HPRA to now move to develop solutions to the problem.

However, industry groups such as Medicines for Ireland point out that the unsustainably low reimbursement price set by the HSE for many of these medicines is often a major driver for shortages.

Many generic medicines are now priced so low as to render them unattractive to global suppliers, who direct these products away from Ireland to higher priced markets.

According to Owen McKeon, Chair of Medicines for Ireland and Country Manager for Mylan: “While everyone is supportive of a reduction in medicines prices from the historic high prices paid for branded medicines in the past, balance is still needed.

Ireland has now reached a tipping point whereby the price of some generic medicines has fallen to such an extent that often a month’s supply can cost less than a bar of chocolate. This is unsustainable over the longer-term. These low-cost medicines continue to be used by tens of thousands of Irish patients but are also often most vulnerable to shortages”.

“This unsustainable pricing has made the Irish market unattractive to global suppliers, who have to factor in development, production, regulatory and staffing costs before supplying the market here”, noted Mr. McKeon.

Medicines for Ireland has also pointed out that the continued long-standing practice of medicine ‘batch sharing’ with the UK is now unclear.

Under the latter system, because of the small volumes of medicines required for the market here, medicines packed in the UK are often marketed and supplied to the Irish market. However, after the UK leaves the EU, its’ medicine regulatory regime may diverge from the existing European regime and by extension Irish regime. This could mean that medicines approved for use in the UK may not be approved for use in the EU and Ireland.

“The risk of an end to batch sharing is a concern for the pharmacy sector. It has always worked in favour of Irish patients who can access medicines here marketed for the much larger UK market by availing of a smaller portion of the UK’s supply. If this practice cannot continue post-Brexit continuity of supply is threatened, leaving patient’s and our health system exposed to shortages.

Medicines for Ireland welcome the HPRA’s lead on this issue. However, we would urge both it and wider decision makers such as the HSE and Department of Health not to explore this issue in isolation from the untenable pricing of some medicines in the Irish market. This, more than anything, is exacerbating medicine shortages here. Brexit will add to the problem of medicines shortages, so we must develop comprehensive solutions which address all the root causes of shortages in advance of the UK’s departure from the EU”, added Mr. McKeon.

Ireland well positioned to secure thousands of additional jobs in pharma sector, if EU moves to reform pharma manufacturing regulations

A leading Irish pharma body, Medicines for Ireland, which represents the generics industry here, with members such as Mylan, Teva, Pinewood, Clonmel Healthcare, met with MEPs on Tuesday to discuss the current Commission proposal to amend the Supplementary Protection Certificate regulations (SPC) which forces the European generic and biosimilar medicines industry to transfer production outside of Europe.

Currently, pharmaceutical companies with patent protected medicines enjoy protection from competition through an SPC. An SPC can afford the holder additional patent protection for up to 5 years.

Under the Commission’s proposal published on 28 May last, the Commission wants to introduce an ‘export manufacturing waiver’ across the EU to allow pharmaceutical companies to manufacture and export medicines to countries outside the EU, where the patent has already fallen.

Given the size and scale of the pharmaceutical industry in Ireland if this proposal delivers its full potential, Ireland and many other European countries stand to gain a significant amount of inward investment in employment and R&D.

Independent analysis, shows that reform of the current SPC regulation has the potential to create up to 25,000 additional manufacturing jobs in the sector across Europe, with Ireland well positioned to secure many of these jobs.

With minor amendments to the Commission’s current proposal, this development could also result in more Day 1 launches, yielding quicker patient access to medicines, earlier treatment for patients and huge savings for the HSE and other European health systems, in addition to shorter, safer supply chains in Europe.

The proposal for an SPC manufacturing waiver has undergone a very rigorous assessment process starting with the Single Market Strategy, an impact assessment and several independent studies e.g. by Charles Rivers Associates and the Max Planck Institute.

Tuesday’s event took place in the European Parliament hosted by Medicines for Europe, the European-wide representative body for the generics industry across the EU and was organised to mobilise MEPs, including Ireland’s, to back the European Commission reform proposal.

Currently, European-based manufactures are protected from competition inside and outside the EU, even where the patent has expired.

The Commission’s current proposal for a waiver will only allow European based medicine manufacturers to commence production and supply of these medicines to countries outside the EU, once a patent expires.

However, Europe’s generics industry argues that its sector should also be permitted to manufacture for countries within Europe, so that patients can access more affordable medicines from the first day on which patent protection ends in Europe.  The current delay on medicine manufacturing until after patent expiry stifles industry R&D, facility expansion and recruitment.

This week’s event in the European Parliament brought together a range of stakeholders who are supportive of the waiver proposal, including officials from European Commissioner for Internal Market, Industry and Entrepreneurship Elizbieta Bienkowska’s office, the Director General of Medicines for Europe Adrian van den Hoven, representatives from the pharma manufacturing, ingredients sector and medicine regulatory sector. Medicines for Ireland were represented by the organisation’s Vice-Chairman David Delaney. Irish MEP Sean Kelly, leader of the Irish EPP Group in the Parliament attended, discussed the proposals and impact for Ireland with stakeholders.

The proposal will require the support of both the European Council and European Parliament. However, the process moved a step further last Friday (22 June) when six Member States - Slovakia, Poland, Portugal, Romania, Greece and Italy, joined Hungary in voicing their support for the waiver proposal. Ireland has yet to set out its position, notwithstanding the opportunity for Ireland from such reforms.

Commenting on the event and the proposal itself, David Delaney, Vice-Chairman Medicines for Ireland and European Director Policy & Market Access Mylan, commented: “I am met with MEPs and other relevant stakeholders this week because Medicines for Ireland recognises the value of this proposal for the pharma sector here. If this waiver is introduced properly there is a massive opportunity to grow our sector further.

There will be tens of thousands of jobs up for grabs. Ireland can and must be in pole position for these jobs. As a country we have already proven our ability to be a global leader in pharma and Medicines for Ireland want to see our existing footprint expand. With high-end jobs with a significant research and development component, this reform represents a huge opportunity for Ireland, so I would encourage all stakeholders to support this proposal”.

“For patients this reform will result in a more competitive medicines market, drive greater earlier and access to medicines in Europe not just outside Europe, with locally produced medicines, and spur on the development of more affordable generic and biosimilar medicines  across Europe,” added Mr. Delaney.

Up to 25,000 pharma jobs if EU alters patent rules

Article by Charlie Taylor

Irish Times, Monday 21 May 2018

Biosimilars are medicines that have no clinically meaningful difference from the original patented biologic medication but, like generics, cost less because they require lower R&D costs. Photograph: Getty Images

Up to 25,000 additional pharmaceutical manufacturing jobs could be created in Europe by 2025 with the Republic of Ireland in a strong position to gain a significant number of the new roles, according to one generic drugmaker.

Mylan, which employs 1,600 people across four sites in Dublin and Galway, said the additional jobs will only come about if a manufacturing waiver on supplementary protection certificates (SPCs) is introduced across Europe.

An SPC is an EU-wide intellectual property right that extends the protection of a patented medicine by up to five years. SPCs effectively compensate patent holders for time lost in getting regulatory approval for medicines.

Under the current regulation, European-based manufacturers are prevented from producing medicines for regions outside the EU during the period of an SPC although such protection may not exist or might last for less time in other jurisdictions.

The European Commission last year launched a public consultation on SPCs but has yet to publish the findings.

Mylan’s European president Jacek Glinka has called on the Irish Government to back the introduction of a manufacturing waiver, saying such a move could boost employment opportunities, increase net sales to the EU pharma industry by €7.3 billion, and ensure faster entry to market for generic and biosimilar medicines.

Mr Glinka, who is also vice president and treasurer for the Medicines for Europe association, made his comments while on a visit to Dublin last week.

Speaking to The Irish Times, Mr Glinka said there were significant gains to be made from the introduction of an SPC waiver, particularly for Ireland.

Jacek Glinka: big pharma companies were lobbying authorities to withhold backing for an SPC waiver to stop manufacturers such as Mylan competing fairly.

“The current regime impedes the growth of additional pharmaceutical manufacturing in Europe and in particular in Ireland, which given its impressive track record in this area, would be in pole position to make investment gains,” he said.


Lobbying authorities

Mr Glinka said big pharma companies were lobbying authorities to withhold backing for an SPC waiver to stop manufacturers such as Mylan competing fairly.

“The whole industry sector agreed to give them this monopoly with the system designed specifically to protect them so that they get their return. But they just want more,” said Mr Glinka.

“It is greedy and unfair. They want to abuse the system and ensure exclusivity continues post-patent update,” he added.

Along with calling on the Government to voice its support for an SPC waiver, Mr Glinka also urged ministers to back more use of biosimilars in Ireland, saying the savings made from switching to them could be reinvested in the health sector.

Biosimilars are biological medicines that have no clinically meaningful difference from the original patented biologic medication but, like generics, cost less because they require lower research and development costs.

Biosimilars were first authorised by the European Medicines Agency for use in Europe in 2007. Ireland currently lags many other European countries in using these drugs, however, with only a handful currently reimbursed by the Health Service Executive (HSE) out of more than 30 currently authorised for use.

Mylan has been developing a pipeline of biosimilars in recent years as a number of patents for big-selling drugs such as arthritis treatment Humira expire.

Minister for Health Simon Harris launched a consultation document on a new biosimilars medicines policy last year. The Irish Pharmaceutical Healthcare Association (IPHA), which represents more than 40 companies, has said the current rules allow for adequate access to the local market for biosimilar drugs.

Mylan, which employs more than 30,000 people worldwide, reported $11.9 billion in full-year revenues in 2017.

The company, which launched an unsuccessful $26 billion (€23 billion) hostile takeover attempt of Dublin-domiciled Perrigo three years ago, finalised a $465 million settlement with the US Justice Department in 2016. This came after it dramatically raised the price for the allergy shot delivery system, EpiPen, by more than 400 per cent after acquiring the patent.


Mylan Country Manager appointed new chairperson of Medicines for Ireland

Medicines for Ireland has announced the appointment of Mylan Ireland Country Manager, Owen McKeon, as new chairperson of the organisation, taking over from Sandra Gannon (Teva Pharmaceuticals Ireland) and Jeffrey Walsh (Pinewood Healthcare).

The appointment will mark the first change in leadership since the organisation’s launch in June 2017.

Since its launch, Medicines for Ireland has engaged with the Minister and Department of Health and wider Government on a number of policy issues and has developed long-term road map for the procurement and supply of medicines in Ireland. Key amongst these has been an ambitious and comprehensive National Medicines Strategy. The organisation has been urging Minister Harris to put in place such a blue-print for the long-term procurement, supply and usage of medicines in Ireland.

Sandra Gannon, outgoing Chairperson of Medicines for Ireland, said: “We are pleased to welcome Mr McKeon as incoming Medicines for Ireland’s chairperson. He brings a breadth of experience to the role that further supports the goals and ambitions of the organisation. Medicines for Ireland has a full programme of work in development for the next 12 months and Owen will play a key part in its roll-out and implementation”.

Jeffrey Walsh, Head of Retail at Pinewood Healthcare, added: “Mr McKeon and Mylan have contributed greatly to the success of Medicines for Ireland since its launch, so as Owen now takes over the role of Chairperson he is already well-attuned to the priorities of the organisation and our member companies. Brexit and the introduction of the Falsified Medicines Directive in particular are just two of the key issues which our sector now faces over the coming months.”

Commenting on his appointment, McKeon said: “It is an honour to be chosen to lead Medicines for Ireland as we approach our one-year anniversary. The organisation has already done much to raise awareness of the issues facing which are critical to supporting access and affordability of medicines for Irish patients. Outside of Ireland, we have also been engaging with European policymakers to promote the interests of Ireland’s pharmaceutical sector, including hosting a Policy Forum in the European Parliament last year.

“As we look to the future, Medicines for Ireland will continue to engage with the Minister for Health, 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, without any justification for this. This has to change.

I look forward to leading Medicines for Ireland on these issues ensuring that Ireland’s approach to medicines serves the best interests of patients and taxpayers.”


Government spent €57.5m on three name brand drugs despite cheaper, equally effective alternatives available

THE Government spent €57.5million on three name brand drugs despite cheaper, equally effective alternatives available.

The HSE has forked out the cash this year on complex biologic drugs Enbrel, Lantus and Neupogen.

However, the Irish Sun can reveal just €500,000 was spent on three equally effective biosimilar drugs in the same period that are all 30 per cent cheaper.

The Department of Health paid almost €8million so far this year for 130,579 units of the diabetic insulin pen Lantus.

Abasaglar does the same job but just 234 packets were issued.

The HSE also sprung for 56,262 Enbrel units, for rheumatoid arthritis, but only 54 packets of Benepali were handed out.

And the State forked out for 22,509 packs of white blood cell stimulating drug Neupogen, which is for chemo users. But only five Accofil prescriptions were filled.

The State’s bill for hi-tech meds jumped from €170m in 2005 to more than €590m in 2016.

Health Minister Simon Harris promises a consultation paper on biosimilar drugs. But Medicines for Ireland, which includes eight of the largest med suppliers to the HSE, doubt the policy will bring savings.

Joint chairperson Jeffrey Walsh said: “While we welcomed the Department’s public consultation and commitment to formulate a national policy, we’re increasingly concerned nothing will materialise from this process.”

A Department spokesperson told the Irish Sun its “National Biosimilar Medicines Policy” will “promote the rational use of biosimilar medicines” in Ireland.


Medicines for Ireland claim that Irish patients are missing out unfairly

Medicines for Ireland, the representative association for generic and biosimilar suppliers in Ireland, has cautioned that a promised new National Biosimilar Policy may lead to no meaningful change.

The association has expressed concern that the State’s existing medicine pricing agreement with IPHA is “protectionist”, claiming that its terms, including an enforced price entry point, restrict competition in the medicine market, in particular for biosimilar over biologic medicines.

The Department of Health completed a public consultation on biosimilars in September and Medicines for Ireland has called on the Department to resist pressure from vested interests to maintain the “status quo”.

The association has highlighted the current “poor uptake” of biosimilars, claiming that this has resulted in a negative impact on affordability and access to medicines for Irish patients.

The association stated: “Biosimilar medicines, which are subject to the same regulatory checks and standards as biologics, have had negligible uptake in the Irish market. In some cases, as low as 0.2 per cent market share”.
Medicines for Ireland has criticised the Department of Health’s failure to create the conditions for competition in the market and the absence of government policy to shape the market.

Commenting on the submission, Jeffrey Walsh, Joint Chairperson of Medicines for Ireland and Commercial Manager, Pinewood Healthcare, said: “Biosimilar medicines have been around for over 10 years now, yet we’re not seeing any meaningful penetration of the market here. Patients are missing out unfairly in Ireland.

“That has to be a cause for alarm. While we welcomed the Department’s public consultation and commitment to formulate a national policy, we are increasingly concerned that nothing will materialise from this process. All the while, significant savings which could ensure increased and faster access to medicines for Irish patients, are passing us by”.

He continued: “Exacerbating the dearth of a government policy to drive a viable market in the Irish market, is the State’s own pricing agreement with the Irish Pharmaceutical Healthcare Association, whose members represent the biologics industry here. This provides for a 30 per cent drop in price on biologic medicines when an equivalent biosimilar medicine enters the market.

“While this discount appears attractive at first, in reality, it is creating a false and, inevitably, closed market. It ensures that the dominant position of biologics is maintained as biosimilars either do not launch here at all or fail to secure any real increased patient uptake, which may inevitably lead to their withdrawal from the market”.

According to Sandra Gannon, Joint Chairperson of Medicines for Ireland and General Manager of Teva Pharmaceutical’s Ireland:

“This blocker clause is sending out the message to biosimilar companies that Ireland is closed for business. The long-term implications of this ill-thought out approach will have negative knock-on effects, particularly for patient access.
She stated: “The 30% discount was sewn into the national medicine pricing agreement in an attempt to block genuine competition. Incumbent biologic manufacturers dominant in the Irish market are actively blocking change, while ironically, also calling on the Minister to provide access to new medicines!

“This attempt to block now extends to a proposal in IPHA’s biosimilar consultation submission document to offer the State an automatic discount, without even a biosimilar competitor in the Irish market, going even further that their existing agreement with the Department of Health”.

In its consultation submission to the Department, Medicines for Ireland has recommended that measures to increase biosimilar uptake, including compulsory biosimilar prescribing quotas or gain share schemes whereby hospitals which switch to biosimilars can share in savings realised.

“We need to move beyond a position of protecting higher cost medicines such as biologics when more affordable but equally safe alternatives are available, to a position whereby we are actively supporting measures which attracts biosimilars to the Irish market, increases their usage by patients and creates budget to pay for new medicines”, concluded Ms. Gannon.


Absence of a unified policy on allergies and anaphylaxis will continue to put patients’ lives at risk

At an event at the European Parliament this week, Medicines for Ireland, the representative association for generic and biosimilar suppliers in Ireland, will highlight to legislators, policy makers and healthcare stakeholders a unified policy on allergies and anaphylaxis could result in less admissions to hospital and decrease the threat to life for sufferers as a direct consequence of anaphylaxis.

Hosted by Mairead McGuinness MEP, Vice-President of the European Parliament, the event will bring together leading experts to review the existing policy environment in respect of allergies and anaphylaxis, and debate a number of core reforms that will better improve the lives of allergy sufferers, including enhanced access to adrenaline auto-injectors (AAIs) in an emergency.

Food allergy is a growing public health concern, affecting more than 17 million people in Europe. It is a leading cause of anaphylaxis in children aged 0 – 14, with research indicating a sharp increase in hospital admissions for anaphylaxis in children – 7-fold – over the last 10 years.

Patient advocacy groups argue that the prescription of emergency medication must be encouraged to protect allergy sufferers who are at risk of a severe allergic reaction or anaphylaxis.
However, in most European countries a prescription is required to carry an AAI and is only usually prescribed once someone has suffered a severe allergic reaction.
Medicines for Ireland, as part of its ‘Responding to public health challenges of anaphylaxis through public policy’’ event, will debate why an EU-wide strategy is needed to improve the health and quality of life of allergy and anaphylaxis sufferers, including better access to AAIs.

“We know that in an emergency, rapid access to medicine is a matter of life and death,” said Owen McKeon of Medicines for Ireland. “That there is not a unified policy on the prevention and management of allergies and anaphylaxis, despite food allergy affecting more than 17 million people and growing, should be of genuine concern to healthcare professionals and national health systems across Europe.

“We are calling on all advocates – legislators, policy makers, healthcare professionals and patients – to implement the necessary reforms and regulation that improves the health and quality of life of food allergy sufferers. We have seen first-hand that the wider availability of adrenaline auto-injectors (AAIs) in the community is achievable. However, without adequate policy, prevention and treatment is varied and access to adrenaline in an emergency is limited.”

Countries like Ireland are leading the way when it comes to better access and wider availability.
This follows the death of Dublin teenager in 2013, when the former Minister for Health Leo Varadkar – now Irish Prime Minister – introduced legislation that broadened the capacity for public access to adrenaline in emergency situations by allowing trained members of the public to administer AAIs where required.

“We believe that all Member States should follow Ireland’s lead in protecting allergy sufferers who are at risk of a severe allergic reaction or anaphylaxis,” said Mr McKeon. “This starts with implementing a number of core reforms, which we will consider, discuss and debate with international experts at our event this week.”
Among those speaking at the event include Professor Dr Antonella Muraro, Past-President of the European Academy of Allergy and Clinical Immunology (EAACI).

Also speaking is Professor Dr Margitta Worm, Head of Allergy and Immunology at Charité Hospital in Berlin, and Irish consultant allergist, Dr Ranbir Kaulsay of the Bon Secours Consultants Clinic and Beacon ENT & Allergy Clinic.

Medicines for Ireland’s broad objective is to support pathways for policymakers and clinicians to work together to develop proposals to advance the core objective of increasing access to emergency medicines to those who need it most, when they need it most.

Saving Lives – responding to the public health challenges of allergies and anaphylaxis

Mairead McGuinness MEP, Vice President of the European Parliament and member of the Committee on the Environment, Public Health and Food Safety, will host a breakfast briefing on the public health challenges of anaphylaxis at the European Parliament on 22 November.

Ms McGuinness hosts the event on behalf of Medicines for Ireland, the representative body for the Irish generic and biosimilar medicines industry.

The event, a high-level, multi-stakeholder breakfast briefing, will discuss the public health challenges around anaphylaxis and access to Adrenaline Auto-Injectors (AAIs) in Europe, with a particular focus on examples of good policy practice as demonstrated by Member States – including Ireland.

Our speakers include Ms Antonella Muraro, Past-President of EAACI and current chair of the EAACI Anaphylaxis Task Force; Professor Dr Margitta Worm, Head of Allergy and Immunology at Charité Hospital in Berlin; and Dr Ranbir Kaulsay, Consultant Allergist at Bon Secours Hospital, Dublin, Ireland.
Food allergy is a growing public health concern affecting more than 17 million people in Europe alone. Moreover, food allergy is a leading cause of anaphylaxis in children 14 years and younger. Research indicates that there is a 7-fold increase in hospital admissions for severe allergic reactions in children in the last 10 years. While anaphylaxis is considered uncommon, figures may be underestimated due to under-reporting of incidence. What is clear, however, is that the mortal threat to life as a direct consequence of anaphylaxis is significant.

In an emergency scenario, ease of accessibility and a rapid response can be a matter of life and death. Countries such as Ireland, among others, have taken a positive step in this direction by expanding access to AAIs – in the case of Ireland, through legislation. We believe that all EU Members States must now work together in ensuring greater access to adrenaline in emergency situations.

This event will consider, debate and examine how to increase awareness of and access to AAIs in practice, and the roles that must be played by all advocates – legislators, policymakers, healthcare professionals and others – to improve the health and quality of life of food allergy sufferers.
We will call on those in attendance to bring the message of a unified policy on the prevention and management of allergies and anaphylaxis, as well as enhanced access to AAIs back to their national governments.

To find out more or register your attendance, please contact Nuala at