According to national and European experts, access to innovative medicines for Romanian patients suffering from rare diseases can be improved in the coming years, as Romania has for the first time the chance, as a member state of the European Union, to contribute to the revision of the Orphan Medicinal Regulation, which was implemented 20 years ago.
National authorities, European decision-makers, representatives of the pharmaceutical industry responded to the initiative launched by the Media Platform www.caleaeuropeana.ro and the Romanian Association of International Pharmaceutical Manufacturers (ARPIM) and held an open dialogue on the access of Romanian patients to orphan and paediatric medicines, as well as on Romania’s role in the forthcoming negotiations at European level for the revision of the Orphan Medicinal Products Regulation.
To ensure that patients suffering from rare diseases have access to medication, the “Regulation on Orphan Medicinal Products (OMP)” was adopted 20 years ago, introducing specific legislation, a definition of OMP, and a specific committee responsible for OMP at the European Medicines Agency (EMA), as well as incentives to promote the development of treatments for rare diseases.
The role of Romania and Romanian experts in the negotiations held by the European institutions
This more than 20-year-old regulation will be re-evaluated, and this is the first time when Romania, as an EU Member State, will participate in the legislative process in the negotiations at the Council level and subsequently in the negotiations between Council and Parliament by submitting successive positions in the negotiations on the legislative act, according to national interests in the matter.
The review of EU legislation addresses the gaps identified by the evaluation with regard to products and their development for the specific needs of children and patients with rare diseases; early access to treatment for these groups and improvement of approval procedures and reduction of inequalities in access.
The European Commission launched another public consultation on 28 September, which will close on 21 December 2021, on the reform of the overall medicines policy framework as part of the resilience of the EU pharmaceutical sector. Thus, the Permanent Representation of Romania to the EU invites key stakeholders in Romania to participate and get involved and, most importantly, make their voices heard at European level.
What happens after the European Commission presents the legislation
Once the European Commission presents the legislative act to the public, the EU Council and the Parliament will start debating it (co-decision). The French Presidency, which will be at the helm of the Council in the first half of next year, will put the proposal on the agenda with a view to finding a compromise with a qualified majority of the EU 27, and the Parliament in parallel will vote on its position at first reading, initially in the ENVI committee and then in the plenary of the European Parliament.
When the Council reaches an agreement it will start negotiations with the European Parliament, the so-called trilogues, and after several rounds of negotiations, a political agreement will be reached between the two co-legislators. Once agreement is reached, the regulation will be adopted and will enter into force immediately after publication in the Official Journal of the EU with immediate legal effect, provided there are no transitional periods and it is a regulation and not a directive. From the moment the public consultation is closed until the publication of the act, Member States, the Council and the Parliament cannot influence the legislative act, as it is pending and in preparation for adoption by the Commission.
Romania will, for the first time, participate in the legislative process in the negotiations at the Council level and subsequently in the negotiations between the Council and Parliament by submitting successive positions in the negotiations on the legislative act, depending on national interests in the matter.
Negotiations between the Member States at Council level take place between the Member States at three levels: at technical level, by Member States’ experts in the working groups on pharmaceuticals and medical devices; at the level of the Permanent Representatives of the Member States and at ministerial level, the EPSCO Council (health component).
In addition to participating in public consultations, Romania will have a new opportunity to participate, contribute and influence the EU legislative process in order to create optimal conditions for ensuring access to treatment for rare and pediatric diseases for the benefit of Romanian patients and to create the incentive framework necessary for the development of orphan and pediatric products for the pharmaceutical industry.
Romania will also contribute to the initiative “a European Pharmaceutical Strategy” and will support ensuring the availability of innovative and affordable medicines for patients, as well as supporting the competitiveness, innovation capacity and sustainability of the pharmaceutical industry in Romania and in the European Union.
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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