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”.

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.