Ireland to seek membership of the BeNeLuxA Initiative


Ireland is to apply to join the BeNeLuxA Initiative in a drive by the Irish Government to reduce the price of pharmaceutical products. The BeNeLuxA Initiative is a collaboration involving Belgium, the Netherlands, Luxembourg and Austria to drive down the cost of medicines. Initially, the BeNeLuxA Initiative will focus on pharmaceutical products and in the context of the growth in personalised medicine, it may extend its coverage to include treatment ‚packages‘ i.e. those involving medicines and/or medical devices.


The aim of the BeNeLuxA collaboration is to make a long-term contribution towards sustainable access to and appropriate use of medicines in the four founding countries. The activities to be undertaken include a shared approach to horizon scanning for new pharmaceutical products and increasing pricing transparency between the partner countries.

The Initiative has indirectly led to two of the partner countries, Belgium and the Netherlands, ending their joint price negotiations with the supplier of Orkambi as they could not agree on an acceptable price for the drug which is used in the treatment of cystic fibrosis. Consequently, Orkambi will not be reimbursed in these two countries.

The Irish Government is hoping that by joining the BeNeLuxA consortium, Ireland can leverage sustainable and affordable access for patients to new and innovative medicines.

The move has potential implications for pharmaceutical companies supplying the Irish market such as Vertex Pharmaceuticals which sells Orkambi. There was considerable public agitation in early 2017 among cystic fibrosis patients in Ireland over the lack of availability of the drug (Ireland has a higher than average incidence of the disease). A pricing structure was eventually agreed between the Health Service Executive, the State organisation responsible for overseeing drug reimbursement, and Vertex with the result that Orkambi is now reimbursed in Ireland.

Currently, drug companies seeking reimbursement for their products in Ireland (or seeking a price change for an existing approved drug) must specify wholesale prices to wholesalers in the four countries that make up the BeNeLuxA Initiative as well as Denmark, Finland, France, Germany, Greece, Italy, Portugal, Spain, Sweden and the UK.

If Ireland does join the BeNeLuxA Initiative, pharmaceutical companies will have to be mindful that their detailed pricing arrangements in the other BeNeLuxA member countries may be shared with the Irish authorities and this may have implications for their pricing strategies in the Irish market.

France, Italy and Switzerland have also expressed an interest in joining the BeNeLuxA consortium.

More details on the BeNeLuxA Initiative can be found on its web site:

The implications of Brexit for sales of medical devices in the UK


In 2016, the results of a referendum in the UK showed that a small majority of the population voted to leave the European Union. Following on from the referendum decision and the triggering of Article 50 earlier this year by the British government, negotiations are currently underway between the EU and the UK on the terms of the „divorce“ settlement and are believed to be making little progress. There is a real danger that the UK could leave the EU without any agreement in place. Such a scenario would have a negative impact for Irish medical device and pharmaceutical companies in Ireland exporting products into the UK, particularly since Ireland is the only EU Member State to share a land border with the UK.

There is little hard information on what will happen to the marketing of medical devices by Irish companies in the British market after May 2019 once the UK has formally exited the European Union. How will a future UK regulatory framework treat devices manufactured and certified in Ireland — or indeed, elsewhere in the EU? Will UK Notified Bodies continue to retain their designation as European Notified Bodies? Similarly, will Authorised Representatives in the UK continue to qualify as European Authorised Representatives under the Medical Devices Regulations? The answer to these questions will depend on how closely any future UK regulatory framework follows the EU framework. It is thought that potential problems could be avoided if the UK were to follow the Swiss model of bilateral agreements that establish mutual recognition of medical devices in the EU. If on the other hand the UK were to develop its own regulatory framework, the additional cost burden to Irish medical device manufacturers — and particularly SMEs — of having to comply with a separate regulatory regime to the EU would be considerable given that the UK is one of Ireland’s largest trading partners (this burden would also have to be faced by other EU Member States).

Irish medical device companies doing business in the UK are already feeling the negative effects of Brexit as a result of the fall in the value of Sterling against the Euro; Sterling has seen its value decline by about 15 per cent. A survey of CEOs of Irish medical technology companies revealed that one in three believe that Brexit will have a negative impact on their business.

US pharmaceutical takes legal action in Ireland over refusal to approve drug for reimbursement


An American drug manufacturer has issued legal action against the public agency responsible for the funding of medicines in Ireland. A new law had been passed under which drug companies can appeal drug funding decisions and this is the first time that this mechanism has been used. The US company, PTC Therapeutics, manufactures the drug, Translarna, which treats boys with a rare genetic condition, Duchenne muscular dystrophy. It is appealing the decision of the Health Service Executive (HSE) to not to approve Translarna for reimbursement under its drug schemes.

The HSE has expressed concerns relating to Translarna’s cost and clinical effectiveness. The company points out that Translarna has been approved by the European Medicines Agency and since 2014 has been used to treat over 400 children in 22 European countries (including Northern Ireland). However, Translarna has not yet been approved by the Food and Drink Administration in the US. The National Centre for Pharmacoeconomics, which had been asked by the HSE to review the economic dossier on Translarna, estimates that the annual cost of the drug would be €411,000 per patient.

PTC Therapeutics which has an operational base in Dublin argues that the process used by the HSE to consider Translarna’s application for funding was flawed. The company says that clinicians have recommended the drug in the case of two boys with Duchenne muscular dystrophy and warns that the window of opportunity for treating them will close soon — the drug can only be given to children while they are still able to walk. The number of children in Ireland with this genetic condition that can be treated with Translarna is estimated at five. Muscular Dystrophy Ireland, the representative body for people with muscular dystrophy, has expressed its disappointment at the HSE’s decision.

FDA partners with Industry on user fees


President Trump signed into law the Food and Drug Administration Reauthorization Act of 2017, extending the user fee agreements with industry that help fund the regulator’s operations for another five years. This step ignored the demands to make the FDA 100% funded through user fees, rather than its current mixture of fees and government funding. The handling of this legislation raised some eyebrows. The industry negotiated the bill with lawmakers in both the House and Senate and supported the version which became law. The Senate passed the bill without any major amendments or policy riders, possibly signaling that major pricing legislation is off the near-term agenda.
The legislation, allows the regulator to collect fees through 2022 to support the reviews of prescription drugs and medical devices, as well as of generics and biosimilars.
The legislation supports competition especially in the field of generic drugs and biosimilars, where the fees for smaller companies are significantly lowered.

Again: The future of US Health is still unknown 


It’s the same story for 8 years: Republican’s “promise” to their voters to eliminate the “Affordable Care Act” (ACA – called Obama care). Now in power, the majority votes with their reelection ahead – a minority follows their conscience. The result: Non.
The question is whether republicans will defund the existing system or not. If defunded, more than 20 million people may lose or be priced out of their health coverage. Some of them will die because of losing health coverage. People who maintain their coverage will be under serious financial stress.
Because of the uncertainty the insurance industry one by one steps out of the ACA and leave the customers not only with soaring premiums and deductibles, but also with dwindling health plan choices. Just for the bare fact to provide health care to individuals the Congress must act quickly to address these growing uncertainties. A lot of themes are on the table – a solution not in sight.

Italy: Pharmacy market is to become more liberal 


Will pharmacy chains be allowed in Italy in the future? This question can only be answered if the house of representatives has voted for a liberalization of the pharmacy market. After some unsuccessful attempts, for example by corruption charges, it seems now that the government is willing to implement the reform project. In Italy there have been so-called parafarmacias since 2006, which are for example pharmacy stands in supermarkets where a pharmacist, who is registered in the professional association, advises clients and sells over-the-counter medicines (e.g. aspirin and other painkillers), homeopathic products, cosmetics and others. In these OTC shops, as the Parafarmacia are also called, however, no prescription, non-recoverable drugs can be sold, the Senate decided last year. For several years, however, supermarket chains like Coop have been fighting for more rights and drug categories. However, Health Minister Beatrice Lorenzin of the Nuovo Centrodestra is now fighting for the liberalization of the pharmacy market, as she considers that a restriction of four pharmacies per pharmacist is no longer up-to-date. In order to guarantee the survival of the pharmacies, the financial stability of the pharmacies is important, therefore the operation of pharmacies in corporations will be allowed. She was also the one who saved pharmacists‘ liability for the so-called List C.


Source: (Apotheke adhoc)


Stringent Health Care Cost Contingencies for Belgium and impact on Drug Spending in 2017


During the last control of the federal state budget, several cost saving measures were announced to cope with ever rising health care cost. A total of around 100 mils. € of cost savings were decided on the drug budget. These contain several initiatives that has impacts on prices as well as on volume. Measures such as the delisting of nasal corticosteroids and change of PPI reimbursement conditions will impact volume, but increasing quotas for the prescription of cheap medicines and subtractions of negotiated discounts and price decreases in the framework of article 81 negotiations from the gross budget to the net budget will also further increase downward pressure on prices. Total budget for 2017 is 4.102.8 million €.


Request for reimbursement of new drug approvals are therefore also meeting ever rising barriers to overcome. “Inappropriate budgeting process puts pressure on health care spending and does lead to inappropriate decisions with regards to the reimbursement of new approved medicines or health care technologies” said Dr Marc Czarka, Managing Partner of HM3A, Brussels. More than ever a careful preparation and implementation of a well thought market access strategy is key to success in Belgium.

The future of US Health is still unknown


Before the election of Mr. Trump as the next President of the US it seemed clear: For the Republicans, the Affordable Care Act (ACA), better known as Obamacare, was an „unpopular law“ and that Congress has already proven it could „repeal and replace“ it. Repealing the ACA was a priority for Republicans. Just some weeks after the election it sounds different: The Affordable Care Act is facing its last few months of existence as we know it. The law can’t be fully repealed – but the Republicans could use measures to defund much of the financial support for the law. The results of the election, has put the ACA “on life support.“ If defunded, more than 20 million people may lose or be priced out of their health coverage. Some of them will die because of losing health coverage. People who maintain their coverage will be under serious financial stress. Until now, there is no plan how the things will play out – it’s known, Mr. Trump prefers to help people keep their coverage, it’s unknown how that would look like. Right now, Mr. Trumps plan, doesn’t match with congressional Republicans‘ previous replacement attempts. After the elections, Republicans have floated plans that would bear some similarities to Obamacare, including tax credits to ensure continued expansion of coverage and methods of providing care for patients. One of the big questions is still open: How to keep alive the inability of insurers to deny people based on a preexisting condition without a mandatory health insurance system? Not only in the USA not all young healthy people are really convinced that they need health insurance. Without a mandatory health insurance system and the inability of insurers to deny insurance for already sick people, they would tend to stay out in millions, which would lead to the collapse of a system where overwhelmingly old people with needs are insured. So, the fight continues and it’s more an ideological than a logical controversy. Even “liberal” Republicans feel the self-build pressure from voters, which like to see the promise to “take down Obama care” implemented. The Trump election could be a negative for the ACA, for Medicare, the insurance for seniors and Medicaid, the health program for the poor’s. The Republicans now own the problems of health care, and they will be judged in future elections for how they address them. Even if he liked to do so, there is just a small chance for Mr. Trump to beat the hardliners in Congress, the pharmaceutical or insurance lobbyists, the American Medical Association (AMA) or other medical lobbyists. With the Republicans ruling the Senate, the Congress and having the White House it seems to be sure, the US Health market moves even more into privatization and it needs to be observed whether Mr. Trump can keep his promise “There will be a much better health care, for less money.

One year from now, we will know.

A new 4-year agreement was signed in July 2016 between the Irish Government and the Irish Pharmaceutical Healthcare Association (which represents 38 international pharmaceuticals in Ireland) to reduce the costs of drugs to the State. The agreement is expected to result in savings to the Government of €785 million over the four years. For the first time, prices will be reduced annually, starting this on August 1, 2016, and July 1st each year afterwards. Prices will be set to be an average of 14 European countries including Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the UK, rather than the current basket of nine. The countries that are new to the basket are Greece, Italy, Luxembourg, Portugal and Sweden. 


The pricing measures agreed include a 20% price cut on biologic medicines upon availability of a bio-similar and a 12.5% rebate on sales of that biologic medicine. The deal will also result in a 50% price cut on entry of a generic competitor to an off-patent medicine.


The Government has promised as part of the agreement that it will put in place a new streamlined process for drugs reimbursement.


US – Healthcare system today


Not only – but especially the US healthcare industry is currently undergoing a seismic shift. More than ever before consumers take a more active role in their healthcare decisions. One of the main reasons are the rising healthcare costs which are catalyzed by demographic and socioeconomic realities. On one hand U.S. is a hotbed of product innovation with new technologies and products, most of them initially very expensive. On the other hand, the U.S. outspends other countries in healthcare, with no clearly recognizable advantages compared to other Western nations, largely because of the heterogeneous population. The Baby Boomer generation have arrived in the life-stage where chronic conditions and health issues are more pronounced.  Despite Obama Care (Affordable Care Act “ACA”) millions of consumers remain uninsured, many utilize emergency services inappropriately. The aim of ACA to increase access to healthcare, improve quality of care, and reduce costs, is supported by the health insurance exchanges which represent a significant shift toward engaging consumers on an individual level versus securing populations through negotiations with employers. Healthcare providers support integrated Electronic Health Records which will facilitate efficiencies in care, and help them to be reimbursed based on medical outcomes and patient satisfaction in the future. The answer for the question “free or more centralized health market” remains still open but may – based on the power of social media – soon be given by the fact of not affordable health care for millions.