Background
The Association of Pharmaceutical Manufactures of Ireland is the trade representative
body for the Generic Industry in Ireland. The members include suppliers of prescription
and non prescription medicines both to the domestic and international markets.
The primary purpose of the APMI is to promote and support the common interests of
the generic industry in Ireland and to be at the forefront of offering quality affordable
medicines to the Irish population.
On behalf of its membership, the APMI is charged with forming appropriate
relationships with the relevant government department including such bodies as DOH,
CPU and HPRA to ensure the introduction and continuous supply of affordable
medicines. The APMI is the recognised negotiating body for all agreement regarding
supply and pricing of generic medicines in Ireland.
The APMI regulatory representation encompasses the expertise and the regulatory
departments of the membership. It is involved with the appropriate bodies such as, the
HPRA, and has responsibility for ensuring that all members comply with general
statutory instruments including the Code of practice on Advertising of Medicinal
products.
Reference Pricing and Interchangeability of Pharmaceuticals.
APMI has a long history of co-operation with the DOH and relevant bodies.
In more recent years due to the difficulties encountered regarding the supply and
pricing of affordable medicines, the APMI entered into a three year agreement for the
supply and pricing of generic medicines from November 2012. This three year
agreement paved the way for the introduction of interchangeability and reference
pricing of Pharmaceutical products in the off patent space.
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Within 16 month of our three year agreement the APMI was approached and an
addendum was agreed to offering additional price reductions prior to the formal
introduction of reference pricing. Included in this addendum it was agreed that there
would not be any further revisions before the ending of the original agreement in 2015.
The reference price mechanism has been successfully implemented and substantial
additional price reductions and state savings have occurred.
It is important to recognise that APMI has delivered the cost savings as per the
agreement.
Generic Penetration:
From the chart below it can clearly be demonstrated that generic penetration
increased from 18.5% in 2010 to 42.4% by the end of 2014 (an increase of 129%).
Between 2013 and 2014 the volume use of Generics grew by 23% whilst the value
has only increased by 0.2%
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In actual terms if we were to look at the products that are in the off- patent space,
penetration of Generics is significantly higher. This percentage level of penetration
is at least equal to similar molecules in some other EU jurisdictions
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Future issues facing the current reference price and interchangeablity
model.
Ireland in relative terms has a small population of 4.595 million people. As a direct
result reference price does not work for low volume off patent molecules, and to generic
companies it is un-economic and a total disincentive to the launch lower value
molecules.
Finally excessive lowering of reference prices for the size of the market has and will lead
further to generic houses exiting that particular molecule causing supply shortages and
will lead to reduced or no competition.
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The future cost saving opportunities:
There are now clearly major costs saving opportunities in addition to the molecule
savings to date, with generic Hi-Tech products now available and with the launch of a
number of Biosimilar products against higher cost originators.
There are currently no systems, mechanisms or incentives for Physicians to prescribe
alternatives to the high cost originator, or incentives for pharmacists to initiate change.
The implementation of changes to the reimbursement system, new incentives,
mechanisms and guidelines would need to be introduced that will help deliver further
significant savings to the health systems.
Biosimilars:
A biosimilar is defined as a biological product that is "highly similar" to a licensed
biological product, without regard to minor differences in clinically inactive
components. There must also be no clinically significant difference, in terms of safety,
purity, and potency, between the "biosimilar" and the original, already-approved
biological product.
The result of increased prescribing of Biosimilars would result in more patients treated
with the same budget, and allow for the introduction and access to new more expensive
medicines, in addition to reducing healthcare costs.
High Tech Drugs (HTD)
Arrangements are in place for the supply and dispensing of High Tech medicines
through Community Pharmacies. Such medicines are generally only prescribed or
initiated in hospital and would include items such as anti-rejection drugs for transplant
patients or medicines used in conjunction with chemotherapy or growth
hormones. The medicines are purchased by the Health Service Executive and supplied
through Community Pharmacies for which Pharmacists are paid a patient care fee: the
cost of the medicines and patient care fees are paid by the PCRS.
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As there is no incentive or guidelines for the retail pharmacist to substitute a cheaper
generic molecule for the originator, the State continues to pay a higher reimbursement
price for such products despite the significant savings that can be made. Like Biosmilars
if systems, incentives and guidelines were put in place for the inclusion of such generics
on the High Tech scheme, it would result in more patients treated with the same budget,
and allow for the introduction and access to new more expensive medicines, while
further reduce health costs.
Key Messages:
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The membership of the APMI want to see far more transparency in the setting of
reference prices
There must be an agreed entry level -60% is far to low.
Less cumbersome method of modulating prices and the introduction of
concessionary pricing.
The membership wants a viable generic market with some degree of pricing
flexibility.
Legislation to be enacted so that Biosimilar and High Tech molecules can be used
to further reduce the cost of Pharmaceuticals in Ireland.
Finally in Summary
The APMI and Generic Manufacturers of Ireland have saved the State hundreds of
millions of Euros over the past two years, and are committed to delivering similar
significant additional savings over the years ahead.
The provision of mechanisms that incentivise the introduction of Biosimilars and High
Tech Scheme products would offer significant savings to the State, and give more
patients in the state access to such current high cost treatments.
The current reference price model has been effective in delivering savings to date on
high volume small molecule products, and the APMI has worked with the state bodies to
deliver these savings. The threshold however that makes this viable has already been
crossed on a range of these molecules/medicines which has made them non-viable to
supply without the introduction of concessionary pricing, and any further cuts will have
a detrimental effect to the supply of medicines in Ireland.
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We as a trade representative body are keen to work with all parties to help assure the
delivery of savings to the state, while assuring continuity of supply and increased access
to treatments for Irish patients.
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IMS IRLP 2014
IMS IRLP 2014
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