1. WHY AN INTERNATIONAL CONFERENCE?

The Access to Medicines Ireland (AMI) Conference has been organised to address the global problem of spiralling drug costs threatening to bankrupt health care systems and deny patients access to essential medicines. The lack of transparency by pharmaceutical companies comes at a critical time, as new (and very effective) cancer treatments priced at an estimated €320,000 per patient per annum come on stream in the Irish market.

2. WHAT ACCESS TO MEDICINES IRELAND (AMI) WANTS

We want medicines development to be regarded primarily as a public health issue rather than as a commercial activity. As such, we want governments to ensure that research is needs-driven rather than profit-driven and that government create price control mechanisms. In order for this to happen:

• We must stop using market exclusivity as a reward to the patent holder of a drug

• Governments must directly fund drugs R&D and reap the savings made on drug prices down the line

3. WHAT AMI IS DOING IN IRELAND

AMI is campaigning so that fair prices can be secured. • We have held two successful conferences involving international experts and key stakeholders and hold our third in the Royal College of Surgeons on 16th April 2019 • On 24th January, we launched our Winter 2018 Policy Document in Leinster House • Subsequently, on 6th March we presented before the Joint Oireachtas Committee on Health. Proceedings are available to watch at: https://media.heanet.ie/page/52de4b67a2404cab82acfce0b5d9f757 • We have held a number of public meetings in Irish Universities during the year seeking to encourage medical, legal and other students to activism • We contribute extensively to the public debate on access to medicines in Ireland including in local and national print and broadcast media

4. WHAT SORT OF GOVERNMENT INTERVENTION IS NEEDED

• We want pharmaceutical companies to be transparent on costs when trying to justify high prices

• We want governments to attach conditions to public funding contributions to drug research to ensure transparency and price controls on medicines developed with public funding

• Consider the use of Compulsory Licence in accordance with TRIPS flexibilities. This would permit the government to authorise generic production of a drug that was deemed unaffordable while offering compensation to the patent holder

• We want the Irish government to use its influence in the EU, WHO and UN to support policies which foster drugs research as a public health rather than a commercial issue

• We want the Irish Government to support and encourage inter-governmental co-operation to facilitate negotiation with the global pharmaceutical industry with initiatives such as BeNeLuxA. The Beneluxa Initiative on pharmaceutical policy enables EU member countries, Belgium, The Netherlands, Luxembourg, Austria and Ireland to improve their mutual position in price negotiations at EU level.

5. RELEVANCE IN AN IRISH CONTEXT

• Prof. Michael Barry, Clinical Director of the National Centre for Pharmacoeconomics (NCPE) sounded the alarm that the available budget for new drugs had been virtually exhausted less than two months in to 2018. (Prof. Barry is keynote speaker at the upcoming conference and will outline the dilemma facing the Irish health system in the near future).

• On 22nd February, it was reported that the HSE failed to reach agreement with Biogen, the manufacturers of Spinraza – a treatment for spinal muscular atrophy in children – on cost grounds. It was estimated that the drug would cost €640,000 per patient for the first year and €320,000 per annum thereafter.

• Ireland is paying €30 million annually for Hepatitis C drugs, which can be purchased at a small fraction of that price in other countries.

• CAR T-cell treatments—a form of therapy that changes a patient's immune cells to attack and kill cancer cells in the body—have been approved in Ireland to treat two types of cancer, a form of lymphoma and leukaemia. They come with a price tag of €450,000 per patient, per year.

6. RELEVANCE IN A GLOBAL CONTEXT

• Antibiotics: Despite the rise of superbugs, pharmaceutical companies have closed down their research programmes on antibiotics mainly because it is not a profitable area. By 2050, it is expected that antimicrobial resistant bacteria could kill an estimated 10 million people annually. That figure currently stands at 700,000. As the current profit driven model is clearly failing in this areas, alternative incentives to a patent/monopoly for R&D are urgently required.

• Global disease burden: Rare disease and diseases that predominantly affect neglected populations are not being prioritised. During the 2014 Ebola pandemic, vaccines and treatment were extremely difficult to access. Currently we have inadequate, toxic or non-existent treatments for many neglected diseases such as Chagas disease, visceral leishmaniasis, and multi-drug resistant tuberculosis.

• Transparency: We are calling for the Irish Government to support the resolution on ‘Improving the transparency of markets for drugs, vaccines and other health-related technologies’ at the World Health Assembly in May 2019. The resolution seeks to end the opacity around drug prices, research and development costs and other related issues. The Irish Government must support the resolution to achieve greater transparency in these areas to enable countries to obtain medicines at a fairer price and allow more people to access the treatment they need.

Proposed solution: A global pool of Research and Development Investment.

7. SUPPORTING FACTS (UN High Level Panel report on Access to Medicines)

• In the last 25 years, virtually no new antibiotics have been developed due to a lack of market incentives—only two new classes for antibiotics have come to market in the last decade, despite the looming crisis of antimicrobial resistance (AMR).

• Of the 12 medicines approved in the US for various cancer treatments, 11 cost more than $100,000 USD per year

• In wealthy countries, 60% of R&D investment is from the private sector and 40% is from public and non-profit sources. But for R&D for diseases that primarily affect the poor, (HIV, TB and Malaria) the public sector provides two-thirds of the funding

• Investment in the research and development (R&D) of health technologies is often impeded by low profit margins. The market’s influence on innovation has meant that many of the world’s health needs remain unaddressed.