New Irish Generics Body Wants “Fundamental” Reform Of Medicines Procurement

by Ian Schofield, Pink Sheet

Two generic industry associations have merged to form a single body that includes the largest generic companies in Ireland. Medicines For Ireland has marked its creation by saying it plans to push for a reform of Irish medicines procurement policies, particularly in areas such as tackling drug shortages, and has called for action to promote the use of biosimilars.

A NEW GENERICS BODY

A newly formed Irish body representing generic and biosimilar companies says it will press for measures to tackle the growing problem of medicines shortages and stimulate competition in the market. It also wants to see the roll-out of the proposed National Biosimilars Policy in order to expand the use of biosimilars and counterbalance what it calls the “unsustainable cost” of biologic drugs.

The new association, Medicines for Ireland, has been created by amalgamating two existing bodies: the Irish Generic Manufacturers Association and the Healthcare Enterprise Alliance. Its members include Accord Healthcare Ltd., Clonmel Healthcare Ltd., Consilient Healthcare, Fannin Healthcare, Mylan Laboratories Ltd., Pinewood Healthcare, Rowa Pharmaceuticals and Teva Pharmaceutical Industries Ltd.

It says its priorities are addressing current drug shortages and creating the conditions for more competition in the pharmaceutical market, including by boosting biosimilar usage, as part of a “fundamental reform of medicine procurement.” It is currently finalizing a policy document on the critical issues facing medicines supply in Ireland, and says its proposals will be published in the coming weeks.

The focus of the proposals will be on:

Developing a longer-term vision for medicine procurement.
Introducing measures to urgently tackle the growing problem of medicine shortages.
Taking steps to create more competition in the medicines market, particularly in hospitals, where the association says spending has grown from €315m ($352m) in 2009 to more than €600m in 2016.
Ensuring the roll-out of a National Biosimilars Policy to expand the usage of biosimilar medicines and counterbalance the “unsustainable cost of biologic medicines.”

“Shortages are becoming a worsening problem” – Sandra Gannon, Medicines for Ireland

Sandra Gannon, manager of Teva Pharmaceuticals Ireland and joint chair of Medicines for Ireland, said the launch of the new group marked the “coming together of the leading players in the supply of medicines in Ireland.” A key aim, she said, was to improve the supply, accessibility and affordability of medicines, and that doing so required “significant reform.”

Gannon highlighted in particular the question of ongoing drug shortages, saying these were becoming “a worsening problem.” According to the association, more than 140 medicines are currently unavailable.

Shortages have been an issue for some time. In a presentation to a European Medicines Agency workshop on shortages in October 2015, John Lynch, director of compliance at Ireland’s Health Products Regulatory Authority, cited some of the reasons as the cost of Irish-specific packs, re-evaluation of the profitability of a product in the Irish context following product divestments, and changes to pack design and livery. He also mentioned increases in parallel trade of certain products as a result of downward pressure on drug prices (which in some cases can also lead companies to withdraw a product from the market for profitability reasons).

According to the Irish Pharmacy Union, a survey of its members in 2016 showed that 99% of pharmacists had experienced drug shortages in the previous three months, and that often pharmacists had no prior warning that medicines were going to be out of stock or any indication when they might be available again.

The IPU too cited parallel trade as a factor, saying that “falling medicine prices are adding to the problem as more medicines are either being exported out of the country to other jurisdictions where medicine prices are higher, or are simply not being supplied.” Among other things it recommended that the government prepare “a contingency plan to consider certain export controls should medicine shortages arise.”

Biosimilars And High-Tech Medicines

Another factor “threatening the supply of medicines to Irish patients” is “the failure to embrace more affordable medicines such as biosimilars,” Gannon said. Her view was echoed by the other joint chair of the new body, Pinewood Healthcare’s commercial manager Jeffrey Walsh, who said that action needed to be taken to tackle “resistance to adopt newer, more affordable medicines such as biosimilars.”

“Time is running out for policy-makers to combat the rising costs of biological medicines” – Owen McKeon, Mylan

Owen McKeon, country manager of Mylan Ireland, spoke of the country’s “underdeveloped approach to biosimilars and the failure of the promised public consultation on biosimilars to materialise,” saying time was running out for policy-makers to combat the rising costs of biological medicines.

The Irish government has promised a National Biosimilars Policy to address the slow development of the biosimilars market – health minister Simon Harris said in September last year that the Department of Health was developing a policy to “create the right market conditions that will enable the biosimilar industry to grow.” And in February this year, Harris said the policy, which is expected to address issues such as switching, pharmacy substitution, traceability, and education of healthcare professionals, would be put out for consultation in the first quarter. (Also see "Biosimilar Firms Say Irish Price Deal Hinders Uptake, As Govt Plans New Policy Measures" - Pink Sheet, 10 Feb, 2017.)

But there is still no sign of the policy. A spokesperson for the department told the Pink Sheet in May that the consultation was “still in the development stages” and that it would be launched “in the near future.”

Also jeopardizing the supply of medicines, Gannon said, was the “spiralling cost of the High-Tech Medicines Scheme,” under which certain high-cost drugs such as TNF inhibitors are reimbursed and where spending has grown by almost €300m over seven years.

Under the scheme, community pharmacies order certain expensive drugs directly from pharmaceutical companies, which are then reimbursed directly by the Health Service Executive. The pharmacies receive a monthly fee for overseeing their patients’ care.

Total spending on the scheme in 2014, including the patient care fee, was €485m, an increase of almost 50% compared with 2009, according to a report by the Comptroller and Auditor General.

Second Name Change

This is the second name change for the Irish generics industry in recent years. In June 2015, the Association of Pharmaceutical Manufacturers in Ireland was relaunched as the IGMA. (Also see "Irish generics association gets new name" - Pink Sheet, 15 Jun, 2015.) At that time the IGMA consisted of Accord Healthcare, Actavis Ireland, Clonmel Healthcare Ltd, Fannin Ltd, Hospira Ireland, Rowex Ltd and Pinewood Healthcare.

Published originally by Pink Sheet and available here


Alliance of generic drug makers warns supply reforms needed

by Paul Cullen, The Irish Times

Group claims patients may face increasing difficulty accessing lifesaving medicines.

A new alliance of generic drug manufacturers has warned that Irish patients will face increasing difficulty accessing lifesaving medicines without reforms to the way they are supplied.
Medicines for Ireland is an amalgamation of the Healthcare Enterprise Alliance and the Irish Generic Manufacturers’ Association.
Its members include the State’s largest generic drug maker, Teva Pharmaceuticals, as well as Clonmel Healthcare, Fannin Healthcare, Mylan and Pinewood Healthcare.
The group is calling for a longer term vision for medicine procurement, measures to tackle shortages of over 140 medicines, and initiatives to create competition in the medicines market.
The cost of hospital medicines has grown from €315 million in 2009 to over €600 million last year, it points out, while the spend on high-tech drugs has grown by 90 per cent.

Rollout
The group is also seeking the rollout of a national biosimilars policy to expand the use of biosimilar medicines, to counterbalance the “unsustainable” cost of biologics.
Its stance is likely to be resisted by the Irish Pharmaceutical Healthcare Association, which largely represents the multinational manufacturers of branded, on-patent drugs, including biologics.
IPHA last year agreed a four-year drug price deal with the Health Service Executive that is expected to yield price savings of about €700 million.
However, the spiralling cost of new treatments means the HSE is unable to provide all the drugs coming on the market. As a result, competition is intensifying between the different sectors of the market.
Medicines for Ireland says its members were to the fore in driving generic substitution in the health service from 2013. Usage of generic medicines has grown from 11 per cent to 53 per cent over the past four years.
The new organisation says it is committed to continuing this reform momentum.


A New National Healthcare Organisation

Medicines for Ireland urges fundamental reform of medicine procurement as supply increasingly at risk

  • Leading Irish medicine suppliers join together to drive reform agenda
  • Reforms vital to safeguard patients, as medicine shortages, access and affordability a growing concern
  • 90% increase in spend on High-Tech scheme adds to growing affordability crisis

A new national healthcare organisation, Medicines for Ireland, has launched today (Monday, 19 June) and is calling for a fundamental reform of medicine policy in Ireland. The group has warned that without critical reforms and a long-term strategy for medicine procurement Irish patients will face increasing difficulty in accessing and affording life-saving medicines.

Medicines for Ireland is a grouping of key medicine suppliers including some of the largest suppliers of medicines to the HSE. The new organisation is a coming together of the memberships of Healthcare Enterprise Alliance and the Irish Generic Manufacturers Association. Its members include Accord Healthcare, Consilient Healthcare, Clonmel Healthcare, Fannin Healthcare, Mylan, Pinewood Healthcare, Rowa Pharmaceuticals and Teva Pharmaceuticals.

Medicines for Ireland’s membership was to the fore in driving and implementing generic substitution in 2013. This policy change resulted in Ireland’s traditional low levels of generic medicine usage being dramatically reversed.  Usage of generic medicines has grown from 11% to 53% over the last four years, with the State achieving hundreds of million in savings as a result. The new organisation is committed to continuing this reform momentum.

Over the period ahead, Medicine for Ireland’s focus will include:

  • Developing a longer-term vision for medicine procurement;
  • Introducing measures to urgently tackle the growing problem of medicine shortages (with currently over 140 medicines unavailable);
  • Proactive initiatives to create greater competition in the medicines market, particularly hospital medicines where spend has grown from €315 million in 2009 to over €600 million in 2016; and
  • The roll-out of a National Biosimilars Policy which expands the usage of biosimilar medicines, to counterbalance the unsustainable cost of biologic medicines.

Medicines for Ireland is currently finalising a comprehensive policy document which will examine the critical issues facing medicine supply in Ireland and will publish its proposals in the coming weeks.

Sandra Gannon, Joint Chairperson of Medicines for Ireland and General Manager of Teva Pharmaceuticals Ireland commenting on the launch of the group noted:

‘Medicines for Ireland’s launch is a significant development. It marks the coming together of the leading players in the supply of medicines in Ireland. We are driven by and share the common objective of improving the supply, accessibility and affordability of medicines for Irish patients. To do so, we need significant reform.

Medicines now play a key part in helping Irish people live better and for much longer than ever before. With the growing importance of medicines, the issue of ensuring that Irish patients can access the treatments they need and the State can continue to pay for these medicines is crucial.

Recent experience has shown such access is no longer guaranteed. Medicine shortages are becoming a worsening problem and increasingly our ability to pay for them is also at risk.

Several factors are threatening the supply of medicines to Irish patients. These include the spiralling cost of the High-Tech Medicines Scheme which has grown by almost €300 million in just seven years (€315 million in 2009 to over €600 million in 2016); increasing medicine shortages with over 140 medicines currently out of stock and the failure to embrace more affordable medicines such as biosimilars’.

Jeffrey Walsh, Joint Chairperson of Medicines for Ireland and Commercial Manager, Pinewood Healthcare, added:

‘We believe that without fundamental reforms at Government, hospital and community levels in how we procure and supply medicines then the existing problems will accelerate. We need reforms across a range of areas including in our national pricing agreements, hospital pharmacy, the extent to which full competition in the market is fostered and in our resistance to adopt newer, more affordable medicines such as biosimilars’.

Noting Ireland’s underdeveloped approach to biosimilars and the failure of the promised public consultation on biosimilars to materialise, Owen McKeon, Board Member, Medicines for Ireland and Country Manager of Mylan Ireland commenting on the launch of the group noted:

‘Time is running out for Irish policy makers to combat rising costs of biological medicines. Irish people have far less access to certain medicines that many of our European neighbours. It’s time for all stakeholders to come together to examine Medicines for Ireland’s proposals’.


Lobby group pushes bigger uptake in generic drug

by Susan Mitchell; The Business Post

A new national organisation seeking reform of the government’s existing medicines policy will launch this week.

The group, called Medicines for Ireland, results from a merger of large pharmaceutical suppliers and includes members of the Healthcare Enterprise Alliance and the Irish Generic Manufacturers Association.

Accord Healthcare, Consilient Healthcare, Clonmel Healthcare, Fannin Healthcare, Mylan, Pinewood Healthcare, Rowa Pharmaceuticals and Teva Pharmaceuticals are among the members.

The companies produce generic medicines and biosimilar medicines, which can be used in place of expensive biologics.

Medicines are typically manufactured through chemical synthesis. Biologic medicines differ as they are derived in some way from living organisms. They include vaccines issues, blood and blood components, as well as gene therapy.

Usage of generic medicines – which are identical copies of the original brand name drugs that are typically sold at cheaper prices – has increased significantly in Ireland recent years.

This has been fuelled by government legislation designed to encourage generic substitution and make savings.

However, Ireland’s uptake of biosimilars remains low, even though spending in this area has increased.

Medicines for Ireland is expected to up pressure on health minister Simon Harris to facilitate the use of more biosimilars, which are typically cheaper than the original.

At a recent event, Sandra Gannon, general manager of Teva Ireland, said uptake of “better value biosimilar medicines is extremely low. Competition is being stifled and prices are higher than they need to be.”

Gannon claimed that reforms to Government policy on biologics could “save the HSE as much as €168 million annually.”

Members of the Medicines for Ireland group are frustrated by the failure of health minister Simon Harris to launch a public consultation on biosimilars, which was promised at the end of February.

Medicines for Ireland is expected to publish a set of policy proposals over the coming weeks and will be urging the Minister and Department of Health to enact them.