Improving market access to medicines

Despite the fact that nine of the world’s top 10 biopharma companies have substantial operations in Ireland and some of the top medicines in the world are produced here, Irish patients are waiting far longer than many of their European counterparts to access innovative new medicines to treat cancer, cardiovascular disease, infectious disease and more.

The significant delay in getting medicines to market appears to lie primarily in Ireland's lengthy reimbursement process following approval of a medicine by the Health Products Regulatory Authority (HRPA) or the European Medicines Agency (EMA).

There are a number of medicines currently stuck in the system awaiting reimbursement that should be available to seriously ill patients, according to the Irish Pharmaceutical Healthcare Association (IPHA).

Innovative new medicines, which are prescribed in hospitals in Ireland, are supplied to patients by the HSE through community pharmacies via the Primary Care Reimbursement Service’s High Tech Scheme. Such medicines include anti-rejection drugs for transplant patients and oncology drugs for cancer patients.

In Ireland, the State pays for approximately 80 per cent of all medicines through four principal schemes: General Medical Services (GMS), Drug Payment Scheme (DPS), Long Term Illness (LTI) Scheme and the Hi-Tech Scheme.

Phillip Hannon, communications manager of the Irish Pharmaceutical Healthcare Association (IPHA), said access to new therapies in Ireland was being delayed because of resource issues that impacted the Health Technology Assessment (HTA) process used by the HSE for evaluating new therapies.

The IPHA has called for the HTA process to be properly resourced to ensure efficient decision-making on proposed new medicines.

“Delay in reimbursement is an issue. There are framework agreements going back three decades between the State and the IPHA to agree pricing and supply of medicines and only last June, we signed a new agreement agreeing price cuts in return for the State making medicines available to patients. We committed to savings of €785 million by 2020, and already €150 million in savings has been delivered in less than a year under this agreement, but only 11 medicines have been approved costing the State only €17 million,” Mr Hannon explained.

While there is a perception among the public that medicines are more expensive in Ireland than other EU countries, Hannon pointed out that medicines were priced against an average of 14 other EU countries. The average spend on pharmaceuticals was 14per cent of the health budget in Ireland compared to an EU average of 19per cent, he noted, and the average price of medicines in the GMS had fallen to below 2001 levels.

Hannon said: “I’m not saying that medicine is cheap in Ireland, but it is priced at an average of 14 EU countries. We are providing the money to the Minister to invest in these medicines, but the length of time it takes to get them to market is getting longer and longer, and some medicines have been waiting years. These include important medicines for oncology, respiratory illness, haematology, and cardiac disease, all waiting in the system.”

The whole issue of access has been magnified by the massive budget implications of the cystic fibrosis drug Orkambi, estimated to cost about €100,000 per patient, but Hannon points out that the vast majority of new medicines coming through are nowhere near this expensive.

While many point to the cheaper cost of medicines in Spain and Northern Ireland, Hannon says that most people are unaware that these medicines are all generics – copies of brand name drugs that are out of patent. There are now more generics being sold in Ireland than branded medicines.

Colm Galligan, medical director MSD Ireland, said the gap between regulatory approval and reimbursement was increasing in Ireland and patients were waiting longer and longer to access new medicines.

The My Healthcare, My Future report, published by MSD last year, showed that more than three in four Irish people believe it's very important that Government and the HSE invest in making new medicines available to Irish people in a timely manner.

Galligan commented: “Industry members made very significant price reductions on existing drugs last year to free up space for reimbursement for new drugs, but there are quite a number of new innovative medicines still awaiting a final decision. We used to have some of the best access to innovative medicine in Europe, but this is no longer the case. We need to do everything we can to get these medicines to the patients and to ensure we are not out of kilter with international standards.”

In his opening statement at the Joint Committee on Health in February of this year, Minister for Health Simon Harris raised the issue that Ireland, in common with many other countries, was facing in relation to the increasing cost of medicines. He pointed out that the medicines bill in Ireland had increased from €400 million in 1998 to more than €2 billion in 2016.

“Securing access to innovative medicines for citizens at an affordable price is therefore a major challenge and not one that is easily solved,” he stated.

The Minister outlined a number of key initiatives that had been introduced in recent times, including agreements with industry, the introduction of generic substitution and reference pricing. He said these initiatives had generated significant savings and reduced prices in Ireland to a more sustainable level.

“Nonetheless, the medicines bill is forecast to rise significantly in the years ahead, driven primarily by the increased cost and usage of recently introduced medicines and the very strong pipeline of new medicines. Therefore, our financing model for medicines needs to be both sustainable and affordable, but the pricing model proposed by industry must also be sustainable and affordable,” Minister Harris stated.

The Minister said it was important that Government challenge the pricing structure and practices adopted by the pharmaceutical industry so that patients could access innovative products. He said he had reached out to his colleagues in other countries seeking international collaboration in this area “as this can be an effective tool to positively influence the pricing strategies of manufacturers”.

The pharmaceutical sector makes a massive contribution to the Irish economy with high quality jobs throughout the country

The biopharmaceutical sector provides around 29,000 jobs directly and well over 50,000 across the country when indirect jobs are taken into account.

More than half of the employees in biopharma industry are third-level graduates, with more than 25 per cent of PhD researchers working in the industry.

Nine of the world’s top 10 biopharma companies have substantial operations in Ireland.

Some of the top medicines in the world and their ingredients are produced in Ireland.

Pharmaceuticals represent around 50 per cent of Irish goods exports and we are the largest net exporter of pharmaceuticals in the world.

Nearly €7 billion has been invested in the pharma sector in Ireland over the past decade.

Replacing pharmaceutical investment in Ireland would cost €40 billion, according to IDA Ireland,

Even during the recession, between 2011 and 2013, over €1.7 billion was invested in the sector which has led to the creation of an additional 1,500 jobs.

The cost of researching and developing a new medicine has gone from €149 million in 1975 to almost €1.4 billion today.

(Figures from IPHA)

The discovery, development, testing and gaining of regulatory approval for new medicines has become an even more highly complex, lengthy, risky and expensive process, according to the Irish Pharmaceutical Healthcare Association report Pharmaceutical Healthcare Facts and Figures 2012.

On average, only one or two of every 10,000 promising molecules will successfully pass extensive tests and stringent regulatory requirements and go on to be approved as medicines, which are suitable for use in patients.

It takes an average of 12 to 15 years to develop a new medicine from the time it is discovered to when it passes the regulatory standards of safety, quality and efficacy and is available to patients.

Once on the market, the average medicine has only eight to 10 years of effective patent protection remaining before facing generic competition. Only three out of 10 marketed medicines produce revenues that match or exceed their R&D costs before they lose patent protection, according to the report.

The contribution of vaccine science to public health

Rather than treating people once they are sick, vaccine science aims to protect people’s health and prevent disease by stimulating the body’s immune system. Beyond infectious disease, researchers are also using vaccine technology in the pursuit of more prevention among more targeted populations.

The hope is that one day it may be possible to stimulate the immune system to control or even stop the spread of cancerous mutations, Alzheimer’s deteriorations, and more.

To date, the only disease that has been fully eradicated in humans is smallpox, while polio is on the verge of being eradicated. Measles has been eliminated from the Americas and was on target to be eradicated from Europe by 2015, before rates of vaccination dropped.

Colm Galligan, medical director MSD, points out that up to three million lives are saved annually through vaccination, according to the WHO, and a further three million people are saved from debilitating side effects.

“What vaccination has contributed to global health over the last 100 years plus is immense, but there is a risk of becoming complacent in this space. We live in an era where false information is quite easily propagated in the public sphere, and it’s important that we remain vigilant,” he says.

Galligan pointed to the outbreak of measles in Ireland last year because of the decreasing rate of MMR uptake.

“There is a community effect where if the bulk of the population get vaccinated, the disease has nowhere to live and that is how it becomes eradicated. If however, the bulk of the population is not vaccinated, the disease circulates freely in the community potentially exposing young babies under 12 months who are not ready for vaccination, and people with compromised immune systems to disease.”