Romania cannot improve its access to the latest innovative medicines without a joint effort of the state institutions in the field and the involvement of patients and industry in solving problems related to access them. According to Romanian national and European experts, Romania lacks financial foresight and a correlation between legislative approaches and patients’ needs.
National authorities, European decision-makers, and representatives of the pharmaceutical industry responded to the initiative launched by www.CaleaEuropeana.ro and the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) and held an open dialogue on the access of Romanian patients to the latest generation of medicines, which is still too limited and difficult compared to other EU Member States.
The main objectives that the Pharmaceutical Strategy for Europe aims to achieve in terms of easy and equitable access to medicines were discussed, as well as what measures need to be taken at national level in order to make timely access of Romanian patients to the latest innovative medicines a reality.
In Europe, patients can wait between 4 months and 2.5 years for access to the same new medicines depending on the country, with Romania ranking last in this ranking. According to the EFPIA PATIENT W.A.I.T. 2020 indicator (published in 2021), countries in North-Western Europe have access to the latest generation of medicines much faster than their neighbours in Southern and Eastern Europe, with patients in some countries waiting more than seven times longer, according to new research. Access is fastest in Germany, with an average of 120 days between marketing authorisation and availability in the country, while Romania ranks last, with an average of 883 days.
All these inequalities among patients in the European Union are intended to be remedied by new strategies and programmes at European level. To this end, the European Commission has launched the Pharmaceutical Strategy for Europe, which is an ambitious project aimed at strengthening the patient focus of the European pharmaceutical system and making it resilient to future health crises. It was adopted last November as a pillar of the European Health Union.
The access to medicines aspects of the Pharmaceutical Strategy for Europe are based on four main themes:
- Medicines available in all Member States at the same time (availability)
- Medicines at sustainable prices (affordability)
- Medicines to be found in local markets (shortages and supply chain)
- Boosting competition
On 30 March the roadmap was published and a first public consultation finalised on 27 April to which ARPIM also had a specific contribution, not only as a member of EFPIA. On 28 September 2021, the European Commission published a new public consultation on the review of EU pharmaceutical legislation. The consultation will run until 21 December and will gather views from both the general public and stakeholders.
ARPIM invites all key stakeholders in Romania to contribute to this public consultation. ARPIM will also certainly contribute to this consultation and make its views available to all interested authorities.
Why do we have the EU’s worst access to innovative medicines approved on the European market?
Efforts are being made at European level to find the quickest possible access solutions for patients, but a permanent dialogue is needed at national level between authorities and industry to reap the benefits of these European projects. Ensuring patient access to state-of-the-art treatments should be a common goal and responsibility.
According to ARPIM, improving the framework for access to the latest generation of medicines is influenced by:
●Clear deadlines for updating the List of Reimbursed Medicines, for its publication and for therapeutic protocols in relation to the issuance of the reimbursement decision.
Methodology aligned with international good practice for calculating the budgetary impact of updating the list of reimbursed medicines.
●HTA – operationalisation of the methodology for taking into account studies in current clinical practice: ARPIM is working on a proposal which it will submit for discussion with the relevant authorities as soon as possible.
● Cost-volume contract: clarify and make transparent the methodology for calculating and renegotiating the eligible population, so that all patients who could benefit from treatment or who are already on treatment in the first year of the contract are included when the contract is renegotiated; diversify the contract models, the existing ones are not adapted to chronic diseases with lifelong treatment or orphan drugs, nor to the increasingly personalised treatments that represent the future of medicine.
● Clinical trials – compliance with legislative timelines.
● Establishing cancer patient pathways and priority and emergency access to investigations for suspected cancer (e.g. initiation of treatment within 30 days of presentation to GP/specialist with signs or symptoms indicative of cancer); paying for testing of biomarkers that can guide treatment much faster and improve its effectiveness.
●Identify an access mechanism in situations with no therapeutic alternative between the issuance of the APP by the EMA and the completion of the assessment for reimbursement.
● Accelerate preparations for the implementation of the new European HTA at national level.
The European access to medicines journey must also stop in Romania
The Romanian Parliament is advocating for adequate funding in the future so that all European regulations aimed at facilitating access to innovative treatments are also implemented in Romania, said Alexandru Rafila, Vice-President of the Chamber of Deputies. He also pointed out that there is no correlation between legislative measures and patients’ needs.
The resilience of the health system has many aspects, and one of them is linked to the possibility of providing medical services, of providing treatment to people even in crisis situations. As far as ARPIM and the pharmaceutical industry area are concerned, models of good practice, of partnership should be found to facilitate access to these innovative therapies and to generic and biosimilar products, because, beyond legislative and methodological changes, a model of collaboration between the authorities and the industry must be identified, so that access to appropriate medication, whether the latest generation or generic and biosimilar, is real and not theoretical.
The Ministry of Finance needs to be present in a future decision-making mechanism in order to manage to ensure sustainability and a financial envelope that is bearable for the Romanian budget in the current situation. It is necessary to explore the elaboration of a multiannual budget that would also ensure predictability in the introduction of new molecules in therapeutic areas.
The representative of the Ministry of Health argues that the main challenge of the system is to ensure the treatment of patients with limited resources, which means that attention must be directed towards all types of drugs. On innovation, the Ministry of Health welcomes the EU support and believes that the European project is a very important resource for Romania in the development of the health system. The Ministry has conveyed that it supports the initiative of an open dialogue to find solutions together, thus ensuring patients’ access to medicines. As for the publication of the list of reimbursed and compensated medicines, the updating of Government Decision 720/2008, this is the responsibility of the Directorate of Medical Assistance of the Ministry of Health.
From the patients’ perspective, access means having the right medicine at the right time, without having to struggle
The Association of Patients with Autoimmune Diseases believes that Romania is far from achieving this goal, and that collaboration and transparency should not remain a declarative statement. The Association stresses that these working groups should be formed and function regardless of who is at the head of the Ministry of Health.
According to the patients’ associations’ representatives, Romania lacks a financial forecast. The Ministry of Health, the Health Insurance House and the Ministry of Finance must present a medium and long term strategy, not just an annual budget but 5 and 10 year forecasts and strategies. There was a call for more flexibility on the part of the authorities, the creation of a special body or department in the Ministry of Health or the National Agency for Medicines to deal with the crisis of medicines and medical devices. Reference was also made to exploring the feasibility of a European mechanism for the procurement of monoclonal antibodies and innovative medicines, as was the case for vaccines, because price is a barrier, especially in a country that has the lowest European budget for health and where health system reform is lagging behind.
The Romanian Representation in Brussels calls for the involvement of Romanian stakeholders in an open and constructive dialogue on the issues that shape the EU pharmaceutical framework
According to the Romanian Representation in Brussels, the Pharmaceutical Strategy for Europe is the flagship initiative of the European Commission which contains all projects and initiatives in the pharmaceutical field. It will support patient-centred innovation and enable adaptation to digital and technological change, one of the objectives being to ensure that patients have access to affordable medicines and that healthcare systems remain financially sustainable.
The representative informed that the Public-Private Partnership for Health Research and Innovation Funding, IMI2, is based on perhaps the most important platform at European level for developing the conditions for the availability of innovative medicines and products with a budget of €5.3 billion, 178 projects and 5248 participants. There is also a European Commission expert group on safe and early access of patients to medicines, the STAMP group, which meets regularly, advises and provides expertise to the Commission on EU pharmaceutical policy.
Innovation must start with patients and their needs, the message from Romanian experts in the European Parliament
Health and health service development, investment and innovation stimulation in this sector should be a top priority for policy makers, not only to fight the current pandemic, but also to prepare our health systems to respond to global challenges and future treatments. Romanian experts are calling for a paradigm shift so that Romania’s healthcare system promotes innovation to develop new products and treatments or to improve care.
The Romanian specialists in the European Parliament also ask the European Union to come up with a financial framework to stimulate patient-centred investments and ask for the involvement of the Romanian state in this chapter. The Pharmaceutical Strategy for Europe tries to reduce this gap in terms of access to innovative therapies, but this strategy focuses very much on the period until the marketing authorisation of medicines, and in Romania problems arise after this approval due to legislative syncopations, experts warn.
Collaboration between state institutions in the field and the involvement of patients and industry remain essential to solve problems related to access to innovative medicines.
Dan Cărbunaru has been appointed spokesperson of the Romanian Government by Prime Minister Nicolae Ciucă
Eu Affairs Journalist, Dan Cărbunaru, founder-director of CaleaEuropeană.ro, has been appointed spokesperson of the Romanian Government by decision of Prime Minister Nicolae Ciucă, published in the Monitorul Oficial.
Dan Cărbunaru is a journalist with more than 20 years of professional experience in European affairs, domestic politics and transatlantic relations.
He has worked for Romania’s main news agencies – Mediafax, Adevărul and Gândul – and later became the host of the TV show “Calea Europeană”, a talkshow on European affairs.
In 2007, he began to develop and broaden his area of expertise by taking up the position of Director of the Communication Department of the Ministry of Internal Affairs, a position from which he distinguished himself by organising in 2007 the first European Home Affairs Communication Conference, an initiative supported and appreciated by EUROPOL and the British Embassy in Romania.
Since 2009 he has dedicated his efforts to his own media project – CaleaEuropeană.ro, a publication dedicated to European affairs, transatlantic relations and Romania’s role in Europe and the world. Today, CaleaEuropeană.ro is the largest European and transatlantic business media community in Romania and one of the largest in Europe.
Brussels correspondent for CaleaEuropeană.ro, Dan Cărbunaru has been a long term accredited journalist to the EU institutions and has reported on the most important moments of the last 15 years since Romania’s accession to the European Union.
After opening the series of Citizens’ Dialogues launched by the European Commission in the EU in 2017, Dan Cărbunaru was chosen to moderate European Commission President Jean-Claude Juncker’s Dialogue with Romanian citizens on 11 May 2017 in Bucharest, the year Romania marked ten years since joining the EU.
Following the Agora – Future of Europe series of public debates, organised by CaleaEuropeană.ro, together with the European Commission Representation in Romania, to promote dialogue with citizens on the future of Europe, Dan Cărbunaru was invited to the biggest European communication event – EuropCom Days, in Brussels, to give a speech about engaging in dialogue with European citizens.
In 2021, Dan Cărbunaru has moderated the official launch of Romanian national debate within the Conference on the Future of Europe.
Dan Cărbunaru’s professional achievements are based on a thorough and wide-ranging academic effort. He graduated in law in 2000, with a research field of “Security in the European Community Area” and is a graduate of the National Defence College and the National Intelligence College.
As a journalist and communications expert, Dan Cărbunaru has dedicated his work to developing, supporting and building networks of citizens who believe in the EU and transatlantic values.
EPP MEP Vasile Blaga: The EU budget for 2022 boosted with significant additional funding for research and health
The EU budget for 2022, the largest in the history of the Union, has been boosted with significant additional funding for research and health, said MEP Vasile Blaga (PNL, EPP) for CaleaEuropeana.ro.
Last week’s session of the European Parliament in Strasbourg approved the European Union’s budget for next year and we are dealing with a first: €169.5 billion for 2022, the largest amount ever approved, €480 million more than the European Commission’s proposal,
“It is worth highlighting here the €100 million annual budget increase for the Horizon Europe research and innovation programme, a key programme for boosting the EU’s competitiveness and economic development. I also note an increase in next year’s budget in the health sector, with the EU’s pandemic response programme EU4Health being funded by €51 million more than the Commission’s initial proposal, for a total of over €800 million,” the EPP MEP stressed.
“It is extremely important not to forget that the pandemic is not over and investing in health is a priority for the European Union in the coming year. A joint effort by all member countries is needed to strengthen national health systems. The same is true in Romania – the national health system has the opportunity to benefit from important funds for modernisation and response, not only to the current pandemic, but also in the long term, to the current challenges in the system”, added the EPP MEP.
The European Parliament last week approved the 2022 budget by 550 votes to 77 with 62 abstentions. The deal, which was agreed by the EU Council on 23 November, is due to take effect from 1 January 2022.
MEPs succeeded in increasing funding for programmes and policies that they believe contribute to post-pandemic recovery, in line with Parliament’s priorities set out in its guidelines for 2022.
These include the Horizon Europe research programme (+€100 million more than the Commission’s draft budget) and the LIFE programme for environment and climate action (+€47.5 million). The single market programme is boosted by €30 million (including €10 million for the tourism sector) and the European Public Prosecutor’s Office by €3.8 million, protecting European taxpayers’ money from criminals.
The Erasmus+ university mobility programme is another programme whose budget is reinforced, with an additional allocation of €35 million. The EU’s flagship health programme, EU4Health, gets a financial boost of €51 million to build a strong European Health Union and make national health systems more resilient.
The Neighbourhood, Development and International Cooperation Instrument (NDICI – Global Europe) has been boosted by €190 million, with a particular focus on fighting pandemics, including through vaccination.
Humanitarian aid has been increased by €211 million to allow the Solidarity and Emergency Aid Reserve to cover the increased needs of the EU Solidarity Fund in relation to natural disasters in the EU.
HERA, essential for countries like Romania. European Union can gain strength in health crises
Romanian experts at national and European level argue that the European Health Emergency Response and Preparedness Authority (HERA) can bring important mechanisms, expected and needed at European level, but which need to be developed in complementarity with existing mechanisms that already have very good results.
National authorities, European decision-makers, representatives of the pharmaceutical industry responded to the initiative launched by Calea Europeană and the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) and held an open dialogue on the role of the new instrument launched by the European Commission, the European Health Emergency Response and Preparedness Authority (HERA), in preventing, detecting and responding rapidly to health emergencies, by collecting information and strengthening the necessary response capacities.
The main lessons learned by the European Union from the beginning of the pandemic to date were discussed, as well as the need to achieve a Health Union, which cannot be possible without the implementation of European mechanisms involving all Member States in preparing a joint response in the event of a future health crisis.
The European executive has succeeded in laying another “milestone of a Health Union” by launching a new instrument, the European Health Emergency Preparedness and Response Authority (HERA). This Authority was launched on 16 September and aims to guide the entire EU health system towards the vision of ‘One Health’. HERA is a key pillar of the European Health Union announced by President von der Leyen in her State of the Union 2020 speech and will fill a gap in EU health emergency response and preparedness.
HERA and its new tasks for a stronger Union in the face of health crises. How HERA becomes a key pillar of the European Union
The Head of the European Commission Representation in Romania, Ramona Chiriac, welcomed the new measures taken by the European Commission to improve the EU’s health security, as this authority is “the result of lessons learnt during the pandemic, which showed the limits of what the EU can do in health crisis situations.”
- HERA reinforces the EU’s powers on health under the existing treaties. HERA’s mandate is forward-looking. HERA’s aim is to anticipate health crises by gathering intelligence, strengthening the necessary response capacity. So far, action in different policies has been taken reactively and not as part of an overall anticipatory management system.
- This will be the new task, to ensure that the European Union and Member States are much better prepared to act in the face of a cross-border crisis, because the pandemic does not stop at national borders or even at European borders. HERA complements the agencies already in place.
The Head of the European Commission Representation in Romania, Ramona Chiriac, also stressed that HERA is chaired by the President of the European Commission, but is constantly mandated by the Council, which means that the will of each Member State is relevant in this construction.
Cooperation with industry within HERA will be essential to develop, manufacture, distribute countermeasures. Such a structured, responsive cooperation mechanism is vital for the implementation of robust supply chain strategies and supply chains with strategically autonomous states.
Since the beginning of the pandemic, Member States have felt the need for a mechanism such as HERA. Romania must have a work core
Valeriu Gheorghiță, President of the CNCAV, present at the debate on the role of HERA, presented a preparedness and response structure in case of a health crisis, based on three pillars that should represent a working core: the prevention part, the pre-hospital part and the hospital part. According to the Romanian specialist, this preparedness and response strategy should have the following structure:
- Prevention strategy: vaccination as an effective means of limiting the spread of contagious disease, complemented by a population education strategy, because accessibility to vaccines is not enough. The population needs to be prepared and to understand that vaccination is a matter of course. Today’s children, who will be tomorrow’s adults, need to understand that vaccination is an added value. For the next health crisis, children must not be exposed to so many misinformation theories. We also need to improve training in diagnostic, surveillance and sequencing capacity: testing and diagnostic capacity is essential.
- Preparedness of the pre-hospital ambulatory medicine system for the identification and treatment of most forms of infections, of infectious diseases that can be very well managed in pre-hospital. There is a need for trained doctors and centres for diagnosis, treatment and access to effective therapies. HERA will enable easy accessibility and a centralised supply chain.
- Hospital preparedness: In pandemic conditions we need to have a response capacity, which means having modular structures and being able to quickly adapt hospital structures to a pandemic crisis or an epidemiological alert.
Stocks of health supplies and medicines were the main challenges during the COVID-19 pandemic
Călin Alexandru, director in the Department for Emergency Situations, says a unified approach is now needed at European level.
The pandemic has highlighted the need for production mechanisms at European level for medical equipment and medicines to ensure that EU citizens can meet their needs in such a situation. An important element that HERA is aiming for is centralised procurement. Romania has so far made centralised purchases, but only at national level. Centralised procurement of vaccines at European level is a very good example of the fact that in such a situation cooperation is mandatory.
There is a need for collaboration and integration of public health response measures and HERA can bring a plus and a positive element. The measures taken by different countries in the first waves of the pandemic were not coordinated and even created difficulties in collaboration within the EU. Measures must be taken in the future that do not affect collaboration, either economic exchanges or the free movement of citizens between countries.
HERA will be the instrument that will ensure the development, production and distribution of medicines, vaccines and other medical equipment among Member States.
Cristian Bușoi MEP, Chairman of the European Parliament’s Industry Committee, explained the benefits of HERA for the resilience of Member States’ health systems.
- HERA is a key pillar of the European Health Union which President von der Leyen announced in her annual speech as being of paramount importance for the European Union to be much better prepared in the future against health emergencies. HERA is not the only answer. We also have the EU health programme, EU4Health, which is totally different from the health programmes of the past. Decisions on health remain with the Member States, but the EU and the European institutions aim to contribute more and more in the years to come.
- HERA will prevent, detect and respond quickly to health crises. HERA will also have to anticipate certain potential health threats and crises. HERA will be that instrument that will ensure the development, production and distribution of medicines, vaccines and other medical equipment among Member States.
HERA, along with other European health initiatives, is essential for countries like Romania
Andrei Baciu, State Secretary of the Ministry of Health, reiterated the importance of HERA for a European Union better prepared to face new health threats, as well as Romania’s essential role in the HERA working groups.
- HERA can be an extremely good opportunity for Romania because it will accelerate the development of internal mechanisms that mirror the work that HERA does. Romanians expect a high level of performance and Romania’s membership of such a European mechanism will force progress in Romania.
- HERA, along with other European health initiatives, are essential for countries like Romania and the benefits of these efforts can be seen in everyday life. Such mechanisms are really the ones that have made it possible for Romania to have vaccines at the same time as any other Member State.The European Health Emergency Preparedness and Response Authority (HERA), essential for countries like Romania.
Romania has started the designation process and is aware of everything that is going on. Work is underway to set up these task forces. There is a lot of activity. Romania is already part of all the mechanisms within HERA and is on track with everything that has been requested so far.
Moreover, the Ministry of Health wants to make the most of these opportunities that this European initiative represents, precisely in order to generate in Romania a health system that can provide European advantages.
The Ministry of Health has said that it is essential for Romania to be part of such mechanisms, but the big problem in our country is that there is no institutional culture to learn from the difficulties we are going through. We have so many things to learn and so many things to improve in European health systems, and the most important advantage of this authority is that it institutionalises this ‘lessons learned’ mechanism and then comes up with concrete proposals.
National legislation must be drawn up to regulate the powers of each institution
The ANMDMR has informed its colleagues in the specialist structures about the HERA regulations. According to the ANMDMR representative, a crucial importance for HERA is the collaboration between HERA and national authorities. Even the Medicines Agency will be involved in this process, but at the moment it is not clear how. ANMDMR argues that a national regulatory act will have to be developed to regulate the tasks of each institution. Different aspects need to be regulated in order to be able to implement the regulation at national level as well. The ANMDMR will indirectly provide support in the working groups within HERA.
In order to ensure a rapid launch and building on the HERA incubator launched in February 2021, HERA will be established as an internal Commission structure and will become fully operational in early 2022. Its operation will be reviewed and adapted annually until 2025, when a full review will be carried out.
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