28 Jan. 2022 - Pharmaceutical Developments on Alzheimer’s Disease

This report, by the Taskforce Horizon Scanning of the Beneluxa Initiative, describes the current situation of Alzheimer’s disease and provides an overview of new pharmaceutical developments regarding this disease. 

The current treatment options are listed, as well as the available guidelines and an estimation of the current pharmaceutical costs for this disease in the Beneluxa countries.

The main focus of the report is on the new pharmaceuticals to enter the market between 2022 and 2027. The setup of the clinical trials, including the used biomarkers, are summarised. Also, the possible challenges, both on HTA level as on Health care level, are described.

With this report, Beneluxa aims to timely inform policy makers, healthcare organizations, payers and the general public on upcoming new pharmaceuticals and possible challenges.

Link to the report

13 Dec. 2021 - Ministers of Health acknowledge the importance of a HTA on Covid Therapeutics

On December 6th, Ministers of Health and representatives of the Beneluxa countries met to discuss the Beneluxa Initiative. Subjects of this exchange on political level were the current state of affairs and visions on national and international policy development. The need for a joint, international Health Technology Assessment (HTA) on Covid Therapeutics was discussed and a shared position to be presented  at the EPSCO meeting of December 7th, underlining the importance of HTA, was developed. 

The importance and the opportunities of the strategic positioning of the Initiative were highlighted and will be further discussed during a next high level meeting.

27 Oct. 2021 - The information on the Joint HTA assessment of ZYNTEGLO has been updated

ZYNTEGLO betibeglogene autotemcel (shorter name: beti-cel) was jointly assessed as a Beneluxa pilot, which led to a successful publication of this joint effort in July 2021. The pharmacotherapeutic assessment was written by RIZIV-INAMI; the pharmaco-economic assessment was written by ZIN as well as the budget impact for the Netherlands and Belgium. The National Centre for Pharmaco-Economics (Dublin) was the external reviewer in the Belgian procedure.
End September 2021, the manufacturer Bluebird bio has withdrawn its application for reimbursement of ZYNTEGLO in the Netherlands and Belgium. Bluebird bio announced to “wind down” its operations in Europe and to focus on the business in the United States. Apparently, the company has tried to find a partner who can market their gene therapies in Europe, but they have not yet succeeded. The Beneluxa initiative regrets the company’s decision to exit the European market.
The HTA report can be found here:
Website written in Dutch; HTA report written in English

08 Oct. 2021 - Outcome of joint negotiations for Zolgensma

Belgium, Ireland and the Netherlands have reached an agreement on the pricing of Zolgensma, a gene therapy for the treatment of Spinal Muscular Atrophy (SMA). Zolgensma will be reimbursed for two specific groups of young patients in all three countries.

The aim of the Beneluxa Initiative is to enhance the access of patients to high quality and affordable treatment. The joint reimbursement process for Zolgensma started with a Health Technology Assessment by Belgium, Ireland and the Netherlands, with Austria as external reviewer in the Belgian procedure. In July 2021 the three directly participating countries initiated price negotiations. 

It is the first time that Belgium, Ireland and the Netherlands have jointly reached an agreement on the price of a drug. While previous Beneluxa pilots have already proven that joint negotiations with two countries can be effective, the process for Zolgensma shows that negotiations by three countries can also be successful. As a result, the gene therapy will be available in all three countries for SMA patients with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of Type 1 and for presymptomatic patients with up to three copies of the SMN2 gene.

Frank Vandenbroucke, the Belgian Minister of Health and Social Affairs:

“Beneluxa is still called an Initiative, but is in the meanwhile a strong ‘brand’ and gold standard for voluntary collaborations between Member States. Our ability to make Zolgensma affordable for SMA patients in our three countries simultaneously shows that Beneluxa’s stated aim to ensure sustainable access to innovative medicines can be translated into tangible and shared results.”

Paul Blokhuis, the Dutch State Secretary for Health, Welfare and Sport:

“Great that the collaboration between the countries is such a success. This partnership makes medicine more accessible and this is great news for the patients who now get access to this medicine. We are committed to continuing this successful collaboration in the future.”

Stephen Donnelly, the Irish Minister for Health:

“The reimbursement of Zolgensma by the HSE represents a great achievement in ensuring access to this gene therapy for two groups of young SMA patients. This is a welcome decision for their families, carers and friends. The success of the joint process for Zolgensma represents a tangible output of the Beneluxa partnership and I wish to take the opportunity to recognise and thank the HSE, including the National Centre for Pharmacoeconomics, and the other participating countries for their significant role in this process.”

Paul Reid, the Irish HSE Chief Executive Officer: 

“The HSE as its standard, engages in commercial negotiations with drug manufacturers to ensure we obtain the best possible value for new medicines. This enables the HSE to reimburse as many medicines as possible, for as many patients as possible, within its resources. HSE decisions on which medicines are reimbursed by the taxpayer must be made on objective, scientific and economic grounds. Providing funding for new high-cost innovative medicines alongside the many demands of the health service presents a continual challenge and the Beneluxa engagement with international colleagues aims to collectively address this challenge.  This is the first time that Belgium, Ireland and the Netherlands have jointly conducted such a negotiation and reached an agreement on the price of a medicine. From today, the HSE will provide reimbursement of Zolgensma for a subgroup of patients who meet the specified criteria on which the Beneluxa assessment and negotiation was based.”

Beneluxa achievements 

In 2015 the Beneluxa cooperation was initiated with the aim of sustainable access to and appropriate use of medicines. Together, Belgium, the Netherlands, Luxembourg, Austria and Ireland want to enhance patients’ access to high quality and affordable pharmaceutical treatments. Besides undertaking joint price negotiations, the partnership works together on horizon scanning, health technology assessments and sharing of knowledge and expertise on policies and challenges yet to come.

Recently, the International Horizon Scanning Initiative (IHSI) has been launched, having originated within the Beneluxa collaboration. Its goal is to build a permanent horizon scanning system that can support countries and institutions in policy planning and their decision making regarding the reimbursement of new pharmaceuticals. A wide group of countries is currently invested in the IHSI.


01 Oct. 2021 - Assessment of COVID-19 monoclonal antibodies is needed

The Beneluxa Initiative considers value assessments of medicines prior to reimbursement in their respective countries, to be essential in quantifying the potential added benefit of treatments relative to the price requested.  This concept was reaffirmed in a recent joint statement with the Nordic Pharmaceutical Forum.1 

The urgency of the pandemic had required some changes to normal medicine regulatory processes to tackle the global pressure on health systems; for the EMA this has resulted in the introduction of rolling reviews.  Rolling reviews involve a real time examination of evidence to establish if sufficient information is available to support a marketing authorization.  This allowed countries to prepare early on for joint procurement of e.g. vaccines at an exceptional time. 

More recently the EMA has begun rolling reviews on monoclonal antibodies to treat some patients with COVID-19 (September 2021)2. However the Beneluxa considers it appropriate at this stage of the pandemic that these therapies3  are assessed for value within established national processes, before decisions on reimbursement or procurement are made. Informed decision making in this matter includes exchange of available HTA information within Beneluxa. 


30 June 2021 - Beneluxa statement: award of contract to supply the International Horizon Scanning Database

We are delighted to share that today the International Horizon Scanning Initiative - IHSI - has made a major step forward in securing development of the international horizon scanning database which is open to all interested countries.

We share the enthusiasm of the IHSI for the future, believing that a big step has been taken allowing the authorities to better prepare themselves for future therapeutic innovations in order to offer patients rapid access to the most appropriate therapies.

Given the fast progress of the initiative, the importance for the public to access medicines within appropriate timelines and the amount of available data, collaboration with a well experienced, dedicated and highly motivated organization, which can provide the necessary tools, was the logical way forward. 

After an international competitive tender process and several selection rounds, we are happy to announce that a promising candidate was found. We are especially proud as we consider IHSI to be the large scale spin-off of our own Beneluxa Horizon Scanning activities. To see our ideas and initiatives come to fruition is a huge accomplishment and pride. Taking this step, key activities will be further divided. While IHSI will concentrate on providing extensive and ready-to-use data, the Horizon Scanning activities of the Beneluxa initiative will focus on how to benefit from this data to the greatest extent.

Link to the news on the IHSI (International Horizon Scanning Initiative) website:

29 June 2021 - Short Statement on Alzheimer’s HTA

The Beneluxa group is following with attention the therapies relative to Alzheimer’s disease coming to the market. Recently the FDA in the US approved an anti-amyloid antibody amid some controversy; a decision from EMA is not yet available.
Beneluxa wishes to emphasize that clinical endpoints such as changes in cognitive scores or dementia scales are considered as the endpoints relevant for HTA agencies in Alzheimer’s clinical trials. Biomarker data are not considered sufficient for demonstration of benefit for HTA agencies.

04 June 2021 - Joint statement of the Beneluxa Initiative and the Nordic Pharmaceutical Forum

In recent years, efforts to enhance international payer collaboration and the willingness to exchange expertise and knowledge have increased substantially. The need for international exchange intensifies due to the challenges that authorities, including payers face concerning pricing, reimbursement and procurement of medicines and therapies. In order to ensure access to new medicines for patients these issues are essential to solve in an effective and rational way. The efforts have materialised in the form of international platforms such as the Nordic Pharmaceutical Forum (NLF); constituting of Norway, Sweden, Finland, Denmark and Iceland, and the Beneluxa Initiative; constituting of Belgium, the Netherlands, Austria, Ireland and Luxembourg. Concrete outcomes of these platforms include the organisation of the international horizon scanning initiative (IHSI) as well as an increased interaction between these platforms. A number of strategic meetings have taken place where other international payers also joined these discussions. Recently, the European Commission has launched a new Pharmaceutical Strategy for Europe highlighting similar issues with regards to ensuring access to affordable medicines. The Strategy specifically refers to the strengthening of existing and potential new cross-country collaborations.

Our joint efforts have focused on a number of issues related to the pricing and reimbursement of medicines. The Beneluxa Initiative and the Nordic Pharmaceutical Forum will initially aim to examine the following matters together:

The importance of cost effectiveness in the assessment of value of medicines. The appropriate use of cost effectiveness offers a framework, which allows decision makers to maximise health gain within a limited budget. It also allows decision makers to estimate the price which is likely to achieve value. Therefore, the certainty of cost-effectiveness should be considered in any negotiations. i.e. the (un)certainty about the effectiveness of the medicine balanced with the high monetary risk.

Availability of robust clinical evidence for decision makers in a timely manner. The Beneluxa Initiative and Nordic Pharmaceutical Forum agree that timely access to effective medicines for patients is important. However, a number of recent developments within the process of market authorisation have been designed to facilitate earlier access to medicines. With this, the challenge arises that there may be a lack of data demonstrating clear benefit at earlier time-points. This makes value assessments increasingly difficult. Therefore, the availability of clinical evidence (including studies where the endpoints are not met) is of vital importance to allow decision makers to adequately assess benefit and value. We aim to mainly examine the following: 1) the timing of the (cost) effectiveness assessment, and 2) the value-framework for assessing medicines in general, with a focus on those medicines for which there is limited or no data to support a decision based on the (cost) effectiveness.

The need to collaborate on the challenges facing decision makers in relation to achieving value from medicines is abundantly clear. We will address some of these issues together through continuous dialogue and an intensification of the collaboration between countries aiming to achieve more alignment in our value assessments.

See also:

28 May 2021 - Beneluxa Statement on high cost SMA treatments

Pharmacological treatments of Spinal Muscular Atrophy (SMA) have expanded across the full spectrum of the disease. Onasemnogene abeparvovec targets disease in patients with SMA who are presymptomatic or who are type 1 symptomatic, and less than 6 months of age.  Nusinersen has a broad licence encompassing type 1 to type 3 SMA and includes adulthood. Risdiplam, which received CHMP positive opinion in February 2021, is the first oral treatment aimed at treating patients from 2 months of age into adulthood (Type 1 to 3).  

It is possible that patients would receive at least 2 different of these treatments over their lifetime. Further, there are additional treatments in the pipeline.  Currently the evidence base at point of regulatory approval mainly considers these treatments as stand alone.  However, sequential use of at least two of these therapies, is not outside the scope of the licences, and has been observed in the clinical setting. Moreover, evidence of the long-term efficacy and safety of these treatments is lacking. 

Given the considerable uncertainty associated with the long term effect of these treatments, health technology assessors and payers should incorporate the potential sequential costs of these high cost treatments. The (financial) risk associated with the lack of long term data and potential use of sequential treatments should not be carried by payers alone.


26 May 2021 - Strategic Positioning for the future of the Beneluxa Initiative

On May 21th 2021, the Steering Committee of the Beneluxa Initiative met virtually. The Belgian Minister of Social Affairs and Public Health, Frank Vandenbroucke, opened the meeting (link to video). 

Updates of the Domain Task Forces on their activities were supplemented by information on the recent outreach of the Beneluxa Initiative towards other collaborations, including the Nordic Pharmaceutical Forum. An important point of discussion concerned the strategic positioning of the Beneluxa Initiative as a key player in the European pharmaceutical landscape and as a thought leader in European and international debate. Further discussions were held with regard to the possibility of specific and aligned Beneluxa processes for HTA and Pricing & Reimbursement. 

21 May 2021 - Beneluxa joint assessment Zolgensma completed

The Beneluxa Initiative announces it has successfully completed another joint effort; the assessment of Zolgensma (onasemnogene abeparvovec) for Spinal Muscular Atrophy (SMA).
Following the reimbursement application by Novartis Gene Therapies with the Beneluxa Initiative, the assessment bodies in Belgium, Ireland and the Netherlands (RIZIV/INAMI, NCPE and the Healthcare Institute respectively) have collaboratively completed the clinical and cost effectiveness assessment of Zolgensma; the Austrian Dachverband der Sozialversicherungsträger was external referee in the Belgian procedure. The assessment bodies are now considering and/or formulating an advice to their national authorities on the reimbursement of Zolgensma and any reimbursement conditions. Once this phase has been concluded, Belgium, Ireland, the Netherlands and the company will decide upon joint negotiations within the Beneluxa Initiative framework.


19 May 2020 - Joint HTA assessment of Zolgensma 

On May 19 the European Commission granted conditional approval for Zolgensma (onasemnogene abeparvovec) for the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1; or for patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene.

The Beneluxa Initiative welcomes a dialogue with the company AveXis/Novartis on access and affordability of the product in each country. Belgium, Ireland and the Netherlands aim to undertake a joint HTA assessment of Zolgensma as part of a reimbursement application by the manufacturer, with Austria acting as the reviewing expert in the procedure. The company AveXis/Novartis has stated its willingness to collaborate on this joint assessment and dialogue on reimbursement. As a consequence, HTA agencies in the three countries will align on the timing and content of the local HTA procedures. Joint price negotiations within the Beneluxa Initiative always start with a joint HTA procedure. Based on the outcome of the HTA assessment,countries will determine if the joint assessment will be followed by a joint price negotiation.

25 February 2020 - Beneluxa Position Statement on CAR-T

Because of considerable upfront costs, CAR-T(°) treatments are in the process of being reviewed by a number of countries to determine whether they represent value for money. Many countries have determined that the early evidence indicates a benefit, but there is uncertainty due to the single-arm nature of the trials and the lack of data in the longer term. The impact of hematopoietic stem cell transplantation in patients treated with CAR-T further adds to the uncertainty as to whether the CAR-T is responsible for the possible prolongation of survival or whether the stem cell transplant primarily contributes to this.

Clinicians have indicated that a proportion of patients in paediatric acute lymphoblastic leukaemia who receive CAR-T are likely to continue to receive stem cell transplants. In determining comparative and cost effectiveness, the influence of this choice of treatment pathway should be carefully considered.  

(°) Chimeric antigen receptor-engineered T-lymphocytes

30 January 2020 - No “lottery for life” - Statement by Beneluxa Health Ministers addressing the global managed access program designed by Novartis and Avexis

The Health Ministers of Belgium, the Netherlands, Luxembourg, Austria and Ireland have strong reservations in relation to  the plans of Novartis and AveXis to let chance decide which seriously ill children will receive medication before it reaches the European market. 

The approach set by the global managed access program is unprecedented and differs significantly from established early access schemes.

The Ministers – united in the Beneluxa-initiative – urge pharmaceutical companies to use objective medical criteria when they allow early access to innovative medicines. 

The pharmaceutical company Novartis has recently applied for Market Authorization at the European Medicines Authority (EMA) for its product Zolgensma ®, for the treatment of Spinal Muscular Atrophy. By announcing this approach, Novartis has raised hope throughout patient communities but has remained silent on the exact plan and the legal challenges of such a system.

In their joint statement, the Ministers express strong concern at the organisation of a lottery-like approach for patients who are eagerly awaiting potential treatment: "The high level of uncertainty and the non-transparent approach is unacceptable. It proves no sincere commitment to patients and only increases the distress of the families concerned. They are given false hope. If one equals the fate of a patient to a lottery ballot, human dignity and moral values get out of sight. Lotteries are by their nature a form of gambling and this is absolutely the wrong model to bring to healthcare.”

Companies are certainly free to provide their products to patients before they are reimbursed. But the ministers involved believe that this should always involve close cooperation with physicians on the basis of impartial medical criteria and medical need.

The Beneluxa Ministers of Health call upon Novartis and AveXis to revise their system for providing early treatment for European patients pending marketing authorisation by the European Medicines Agency (EMA). 

Commitment to patients

The Public Health Ministers of the Beneluxa Initiative appreciate the company's efforts to develop a drug for this vulnerable patient group. Alongside patients and prescribers, they await the final marketing authorisation for the product.

The Ministers fully understand the motivations of desperate parents fighting for the life and well-being of their children and their physicians to secure a life-saving treatment and are fully supportive of a properly implemented early access programme that could benefit individual patients.

The Ministers from the Beneluxa initiative have a commitment to patients to fight for sustainable access to medicines in their countries. They strive to increase patients’ access to high quality and affordable treatments. In a fair and accountable manner. 

If the drug is approved in Europe, this treatment for spinal muscular atrophy will be the most expensive drug to date with an estimated cost of 2 million EUR per patient.

The Ministers therefore urge Novartis and AveXis to enter into a genuine dialogue with the Beneluxa initiative to explore sustainable, clinically and ethically appropriate ways to provide this medication to all young patients who need it after obtaining marketing authorization.

04 December 2019 - Beneluxa experts and leaders met: “We are open to engage the next pilots” 

On 25 and 26 November 2019, the Beneluxa Initiative held its Steering Committee meeting and General Assembly in The Hague and considered the progress made in the collaboration and the future work agenda. Technical experts have been collaborating to produce HTA reports; a common template for submission of a dossier and HTA reports has been developed and is ready to be piloted. In addition, the International Horizon Scanning Initiative (IHSI) was established as an independent legal entity earlier this autumn ( and will be operationalised during 2020. IHSI had been initiated by Beneluxa but is open to further countries to join (currently 9 countries participate in IHSI). The Beneluxa representatives also discussed the concept of transparency, based on the earlier position of Beneluxa on transparency (see 16th May below), and considered options of how to respond to the resolution on improving the transparency of markets for medicines, vaccines and other health products adapted by the World Health Assembly in May 2019 in an effort to expand access.


27 November 2019 - Building an International Horizon Scanning Initiative

Horizon Scanning aims to highlight important pharmaceutical and medical technology innovations before they reach the market  by continuously gathering data and analyzing research and literature. 
This improves insight in expected costs and enables timely decision making and (joint) price negotiations.
The Beneluxa Initiative on Pharmaceutical Policy aims to seek successful ways of collaborating on pharmaceutical policy. One of its goals is to set up a systematic approach on horizon scanning for pharmaceutical products through IHSI. The IHSI is open to any interested country. Countries interested in participating in the IHSI can contact

Link to the official IHSI website:

The Kick-Off Meeting of IHSI took place on 29 Oct. 2019.

kick off IHSI

Link to press releases:

27 November 2019 - Cross-collaboration meeting on strategic decisions for pricing and reimbursement

On 27 November 2019, the Beneluxa Initiative hosted an exchange with 11 countries in Den Haag, The Netherlands. Representatives from Austria, Belgium, Canada, Denmark, Finland, Iceland, Ireland, The Netherlands, Norway, Scotland and Sweden discussed future opportunities for experts to interact beyond existing collaborations such as the Beneluxa Initiative and the Nordic Pharmaceutical Forum. 

The goal was to discuss solutions to ensure sustainable and equitable access to effective medicines. Topics spanned a variety of issues, such as the lack of evidence on the effectiveness of high-priced new medicines and the increasing pressure on pharmaceutical budgets. There was a general and fruitful exchange of thoughts on methodological approaches including willingness to pay.

16 May 2019 - Steering Committee of the Beneluxa Initiative

On May 15th 2019 the Steering Committee of the Beneluxa Initiative met to discuss the following topics:

  • The next steps for the International Horizon Scanning Initiative (IHSI)
  • Ongoing activities of the Beneluxa Initiative, among which selection of new candidates for joint HTA and potential joint negotiations
  • Strategic ways to move forward with the activities of the Beneluxa Initiative
  • Transparency of prices:

The members of the Beneluxa Initiative highly value transparency as a key contributor to achieving sustainability of access to medicines. Transparency will assist in improving insight into the inner workings of the pharmaceutical value chain. We strongly support access to data generated by clinical research, including negative and inconclusive outcomes. We welcome a wide debate on these topics and further discussion at international level. The first concrete step should be to create price transparency among countries

05 March 2019 - Building an International Horizon Scanning Initiative

Horizon Scanning aims to highlight important pharmaceutical and medical technology innovations before they reach the market  by continuously gathering data and analyzing research and literature. 
This improves insight in expected costs and enables timely decision making and (joint) price negotiations.
The Beneluxa Initiative on Pharmaceutical Policy aims to seek successful ways of collaborating on pharmaceutical policy. One of its goals is to set up a systematic approach on horizon scanning for pharmaceutical products through IHSI. The IHSI is open to any interested country. Countries interested in participating in the IHSI can contact

Open market consultation for Horizon Scanning

The open market consultation that took place end of 2018 aimed to inform companies and organisations that are active in this market regarding the upcoming public procurement procedure for the setting up of an international horizon scanning system (HSS) that will be initiated as a joint effort by the countries participating in the IHSI. The market consultation also aims to obtain market operators’ input on the viability of the procurement design and conditions, before launching the call for tender, provisionally planned in the first quarter of 2019. 
The market consultation was open to all interested parties, regardless of their geographical location, size or governance structure of their organisation and was published on October 20th 2018 on the EU’s Official Journal (TED). On November 12th 2018 a meeting was held in the Hague for interested parties. The presentation from this meeting can be found below. The market consultation ended on the 27th of November 2018. 

Results of open market consultation

The open market consultation has been concluded and the results can be found in the document below. The preparations for the tender launch are being made and interested parties will be informed as soon as more information can be made public on the tender procedure and timelines. 

Last update: 05 March 2019


18 February 2019 - General update

On 22 November 2018, the Steering Committee of the Beneluxa Initiative discussed in Vienna key topics concerning the collaboration in the areas of the horizon scanning (see also the current Open Market Consultation Announcement on “Building an International Horizon Scanning Initiative” and joint HTA reports. Other topics of discussion were transparency of negotiated results within the Initiative and strategic ways to move forward with the activities of the Initiative.

Last update: 18 February 2019


12 July 2018 - Positive outcome of joint reimbursement negotiations on Spinraza

Beneluxa Initiative partners Belgium and the Netherlands successfully negotiated the reimbursement of Spinraza

Belgium and the Netherlands have reached an agreement on the pricing of Spinraza, a drug for Spinal Muscular Atrophy (SMA). Spinraza will be reimbursed for specific groups of patients in both countries.

The aim of the Beneluxa Initiative is to enhance the access of patients to high quality and affordable treatment. The agreement on Spinraza is the first positive outcome of a joint negotiation of the Beneluxa Initiative. As a result of negotiations, which started in February of this year, Spinraza will be reimbursed in both countries under similar conditions. The joint process consisted of a joint Health Technology Assessment, followed by a joint price negotiation. 

Although previous pilots have proven that joint negotiations can be successful, this particular case is a great achievement that benefits patients in both countries. 
Ireland has recently joined the Beneluxa Initiave too. With several pilots ongoing, the aim is to expand future negotiations with other Beneluxa partners and to enhance efficiency by streamlining reimbursement processes in different countries.

Bruno Bruins: ‘First and foremost, the positive outcome is wonderful news for the young SMA patients and their families, both in the Netherlands and Belgium. It is also a very clear and promising example of the benefits of working together on price negotiations and pharmaceutical policy. Biogen’s willingness to engage in a joint process and discover the benefits of gaining swift access in several markets at the same time is a positive development. Therefore I hope more companies will follow this example.’

Maggie de Block: ‘I am delighted to be able to make this orphan drug available to our SMA patients, barely one year after it received a marketing authorization. There was no treatment at all for these patients, but that is now changing. This means a giant step forward for these people and their families. At the same time, I am very proud of how we have tackled this. Today, we demonstrate that countries can jointly negotiate the reimbursement of orphan drugs to the benefit of their patients. This is a very important signal for everyone involved in Beneluxa and an extra motivation to further develop this international cooperation.’

For more specific details on the reimbursement of Spinraza in Belgium and the Netherlands, read the specific press releases:
Link Belgium
Link The Netherlands

22 June 2018 -  Ireland joins Beneluxa initiative

Ireland joins

Today, the Irish Minister for Health, Simon Harris signed an Agreement with his colleagues from Belgium, The Netherlands, Luxembourg and Austria to join the Beneluxa Initiative on Pharmaceutical Policy. The ceremony took place during the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) in Luxembourg. Ireland is the fifth country to join the collaborative alliance on pharmaceutical policy.

Minister Harris stated: “I am pleased that my Ministerial colleagues from Austria, Belgium, The Netherlands and Luxembourg have enabled Ireland to join this exciting, international collaboration on drug pricing and supply.  I want the newest and most innovative medicines to be available in a timely manner to all our citizens. This collaboration will assist us in doing just that by ensuring that medicines can be sourced at a price that is affordable and sustainable in the context of the ever competing demands for resources rights across our health service”. 
The BeNeLuxA Ministers responsible for pharmaceutical policy welcomed Ireland joining and participating in the collaboration. 

Dutch minister Bruno Bruins for Medical care said: “Ireland is a great addition to the Beneluxa family. All five countries face similar issues regarding  access and affordability to new and innovative medicines. By joining forces we improve our mutual position in price negotiations towards the pharmaceutical industry and we have a stronger voice at European level. In this way we can ensure that our patients can count on access to affordable, innovative medicines in the long term”.

Belgian minister Maggie De Block of Social Affairs and Public Health said: "Four years ago, each country still worked on its own. Today,  we are five countries joining forces, our objective being to offer the best care possible, as soon as possible and in a sustainable way to  all our patients. I hope that other European countries will join us soon. Because the more patients we represent, the more our voice will be heard when discussing high-cost innovative medicines".
Luxembourg minister of Health Lydia Mutsch said: “We believe that information sharing and collaboration between countries will benefit policy initiatives on pricing and reimbursement of medicines. By working closely together, we can better negotiate medicine prices with the industry and request more transparency on the cost build-up of pharmaceutical products. Our aim is to ensure patients’ fair and sustainable access to essential medicines.

Beneluxa achievements 

In 2015 the Beneluxa initiative was initiated aiming for sustainable access to, and appropriate use of, medicines in the participating countries. Together, the countries want to enhance patients’ access to high quality and affordable pharmaceutical treatments. The cooperation is not limited to joint pricing negotiations. The coalition also works together closely on a horizon scanning, to explore which innovative – often extremely expensive – medicines are expected to reach the market in the near future. In addition, the Beneluxa partners conduct joint health technology assessments and share data and policies. The collaboration recently introduced the international horizon scanning initiative (IHSI), that goes beyond the current coalition of countries. Its goal is to build a permanent horizon scanning system that can support countries and institutions in policy planning and their decision making regarding the reimbursement of new pharmaceuticals. A wide group of countries is currently invested in developing the IHSI further.
More info on the Beneluxa initiative can be found on

24 May 2018 - Steering Commitee Meeting

On the 24th of May 2018, the Steering Committee of the Beneluxa Initiative met in Brussels. On the 25th of  May 2018, the Beneluxa General Assembly took place. A representative of Ireland, at the time in process of joining the Initiative, participated in the Steering Committee meeting.
The following topics were discussed:

1. updates on the on the Initiative’s four Domain Task Forces:

2. Alternative business models to develop medicines (such as the Fair Medicines Initiative)

3. Austria’s planned activities related to pharmaceutical policy under the upcoming EU Presidency

4. Developments concerning the reimbursement of pharmaceuticals in Europe

5. The Beneluxa Initiative has opened a twitter account to announce news and new content on the website. The Beneluxa Initiative twitter can be found at

18 January 2018 - Steering Commitee Meeting

The Steering Committee of the Beneluxa initiative met in Luxembourg on 18 January 2018.

Experiences with joint HTA reports and joint negotiations were assessed, and the planned activities for 2018 in the areas of HTA and pricing and reimbursement were discussed. Topics included a discussion of moving ahead with collaboration in the areas of Horizon Scanning and patient registries.


28 November 2017 - Orientation Meeting on Patient Registries

Policy makers and national patient registry experts from Beneluxa countries, Hungary and the United Kingdom met in Vienna on 28 November 2017 to explore a possible collaboration in the field of patient registries in order to increase efficiency, and enhance evidence generation and information sharing. 

The meeting aimed to identify the challenges and prerequisites for collaboration in the field of patient registries, and ways to move forward. As a supportive exercise, results of a preliminary mapping of patient registries in the member countries of the Beneluxa initiative were presented. As different types of registries exist, key learnings included the need for a clear definition of patient registries and scope in order to determine which type of registry would be appropriate for a potential pilot in the near future. Furthermore, technical and political challenges of a joint registry (e.g. interoperability of datasets, legal framework/collaboration agreements, as well as how necessary information can be collected) were identified. 

The Beneluxa partners will further explore a collaboration in the field of patient registries. 


11 November 2017

Information on the first results of actual joint HTA procedures are available here.


6 September 2017 - Website of the Beneluxa collaboration launched

The competent authorities of Belgium, the Netherlands, Luxembourg, and Austria have committed to cooperate in order to contribute towards the sustainable access to medicines in their countries.

Further information on the Beneluxa cooperation can be found on this website, which was launched on September 6, 2017.


27 June 2017 - Meeting on Joint Horizon Scanning

A meeting was organised in Brussels on 27 June 2017 to explore options for potential collaboration between authorities on Horizon Scanning - even beyond the Beneluxa countries.