Archive for the ‘European Union’ Category

The EU’s Coronavirus Response Initiative: An interview with Felicity Spors, Head of International Affairs Strategy at – Daily Planet`

17 Apr 2020

The coronavirus outbreak has struck Europe with stunning ferocity and presents a major challenge to the people and economies of the European Union. Today, our healthcare systems are under considerable pressure, which has led to the dramatic consequences we know today. As we write these lines, the pandemic has affected the day-to-day lives of billions of people and has taken 145,568 lives.

As physical distancing and lockdown spread throughout the world, governments took rapid action to support our economies, understanding the appropriate measures taken to contain the virus will result in far-reaching economic consequences. At the end of March, the European Commission released an emergency package, the Coronavirus Response Investment Initiative, both to contain the spread of the virus and to mitigate its impact on public healthcare. The 37 billion plan is a response to emerging needs in the most exposed sectors, such as healthcare, SMEs and labour markets. On 2 April, the European Commission launched a new initiative, the Support mitigating Unemployment Risks in Emergency (or SURE). This initiative will provide financial assistance of up to 100 billion in total to Member States in the form of loans granted on favourable terms. The aim is to help workers keep their incomes and help businesses stay afloat and retain staff. In addition, the European Commission has proposed specific measures to support Europes fishermen and farmers, and proposed to redirect every available euro from this years EU budget to save lives through a new EU solidarity instrument. See more on the EU response here.

Felicity Spors, Head of International Affairs Strategy at EIT Climate-KIC, welcomes these initiatives and argues it is vital we support an economic recovery, since without it, the economic and social repercussions on individuals would be disastrous. She emphasises the importance of ensuring these investments support our economies and societies to become more resilient to future potential risks (including additional pandemics and climate change) and reflects on lessons learned from the last time the EU had to support the economyduring the 2008 financial collapse.

Ursula von der Leyen introduced the Coronavirus Response Investment Initiative by saying: We will use all the tools at our disposal to make sure the European economy weathers this storm. This resonates with what happened after the 2008 global financial crisis. What are your first thoughts about the EU responses so far?

I welcome these initiatives, as they are essential to support Member States to manage the public health crisis and there is hope these measures will also mitigate the looming economic crisis. This health and social crisis have brought an unprecedented halt to the worlds activity and the economic consequences of the pandemic are causing great concern. Although we have survived sudden economic downturns in the past, such as the 2008 financial crisis, its important to recognise we are in a very different situation today.

The collapse in 2008 was triggered by unsustainable practices in the financial sector. Governments bailed out the largest players, which was rationalised on the grounds that some financial institutions were too big to fail i.e. the impact of their failure would be a greater cost than using public finance to support them. What we are facing today is very different. The coronavirus pandemic highlights vulnerabilities not just in the financial system but in our health systems, our value chains and our emergency response systems, which lack resilience and robustness in the face of crises.

This health crisis could lead to a full economic collapse, at a scale much bigger than in 2008. Between 2008 and 2014, 1.5 trillion in different forms of rescue packages was used to rescue Europes banks. Looking back today, we can only regret that we missed an enormous opportunity to use this public money to set the world on a more resilient and greener path by tying the bailout to sustainability objectives.

How do we make sure this doesnt happen again?

We need to look at how the current rescue packages will be delivered, and there is a legitimate fear the loudest voices will get the biggest piece of the cake. There have already been messages from the automobile industry in Germany to reduce environmental emission standards on cars to help them emerge from the Corona crisis.

A problem with todays situation is citizens are not alert to the avoidable emissions that rescue packages may be locking us into during a critical moment for climate change, and we cant expect them to be. Were in the middle of a pandemic. People are worried about their health and the health of their family, they have to home-school their kids, while making sure their work isnt disrupted. There is also an enormous economic concern among the population, as it becomes clear many small businesses (from hairdressers to books stores, restaurants, etc.) wont survive the economic crisis.

What specific impacts could this health crisis have on European sustainable policies?

Governments have the huge responsibility to balance the immediate needs brought by the coronavirus pandemic, with the longer survival needs of people, the ecosystem we live in and our planet. One of the main concerns today is the European Green Deal will be put on hold. Andrej Babis, Prime Minister of the Czech Republic, has already publicly said the European Green Deal should be set aside so countries can focus on fighting the pandemic. The European Commission assures they are going to proceed, but many observers are concerned the framing of the European Green Deal, the language around it, may change.

We know investment in the green deal will provide jobs and new economic growth opportunities. The European Green Deal Investment Plan will mobilise at least 1 trillion of sustainable investments over the next decade. With this framework, which aims to facilitate the public and private investments needed for the transition to a carbon-neutral, green, competitive and inclusive economy, the European Union has positioned itself to be a leader in climate change. It is so important it does not go backward.

What clear signs could the European Union send today, to show their commitment to build a sustainable future?

European policymakers have already committed, through the EU Taxonomy, for sustainable activities to align with a no gas, no oil, no nuclear future. Today, they have a very clear choice to make. It is to not utilise precious and limited public money to support polluting industries. We dont have to bail out conventional energy systems. Instead, we must scale back subsidies for fossil fuels, and help retrain workers. We need to be people-centred in the way we deal with health, climate and biodiversity crises.

The financial emergency package must also be used to fix broken systems such as our health systems (which we realise today, are not well equipped to face existential threats). The way governments decide to spend this money will shape our health, economic and political systems for years to come. While governments need to act quickly to answer this health emergency, the European Commission should make sure everyone is considering the long-term consequences of the bailouts.

This public money should be used to shape systems that serve the planets and peoples interest, not to go back to business-as-usual.

Speaking of going back: A few people, including President Macron, said there will be a before and an after coronavirus. Drawing lessons from the 2008 financial crisis, can you expand on why we shouldnt go back to where we come from?

I agree things wont ever be the same as well most likely have an economic collapse. The world is going through a very challenging time but it is a transition moment. Using these packages, that public money, to rebuild the pre-coronavirus society would be a mistake. We need to invest now in greater resilience to future pandemics, economic collapses and climate risks.

When it comes to the climate emergency, were past the warning stage. Time is running out, as shown in the latest reports by the UN Intergovernmental Panel on Climate Change. Inaction did not serve us well in the Corona pandemic, it will not serve us ahead of the impending climate emergency.

The missing ingredient is the political will to act as if this is a shared global emergency, to drive the behaviour change that will allow these changes to be embedded in our framework. The health crisis has shown governments have the ability to take urgent and radical action to contain crisesto make bold leaps into a new world. This is the kind of leadership we need for the climate.

The question now is: Can we use this moment to pivot investments towards goals that governments have already set themselves internationally, and nationally? This is an important but difficult question to ask, and to answer. But we must not be shy of asking difficult questions. The mistake would be to not deal with these questions collectively. With COVID-19, we are learning the importance of collective coordination: It is the key to addressing these global crises and it is essential for meeting the climate goals.

We now need to move through this moment of real tragedy to invest in resilience, shared prosperity, wellbeing, and planetary health. We have long since exceeded our natural limits. It is time we try something new.

EIT Climate-KICs COVID-19 Response: We believe the world needs a simultaneous, multi-dimensional response to COVID-19, to address both the devastating immediate impacts on people, health systems and economy, and longer-term considerations. This includes the need to act now to ensure that economic recovery is aligned with climate and Sustainable Development Goals commitments as we consider ways to protect, reboot and regenerate economies. EIT Climate-KICs COVID-19-related communications will respond to all of these needs.

Please visit our COVID-19 Response Hub for more information.

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The EU's Coronavirus Response Initiative: An interview with Felicity Spors, Head of International Affairs Strategy at - Daily Planet`

The EU must not let the four horsemen of the Apocalypse weaken Europe’s security View – Euronews

Were there not four horsemen of the Apocalypse? Just as the virus was spreading in China, Europe was having to deal with the border crisis with Turkey, a humanitarian crisis in Syria, a civil war in Libya, keeping Russia at bay and responding to instability and terrorism in the Sahel. At the same time, Europeans were scratching their heads about how to deal with President Trumps America First strategy. There was a little thing called Brexit, too. Of course, none of these problems have gone away and they will remain regardless of how many future waves of COVID-19 appear.

Several commentators believe that these issues are nothing in comparison to the epochal changes we are about to face because of the pandemic. Many are already talking about the end of or, at the very least, a reconfiguration of globalisation. Linked to this assumption is the idea that strategic competition between the US and China will likely intensify as both states try to readjust their economies, while exercising a form of social distancing in strategic terms. With this reading, it is as if the horses of plague and conquest are already upon us.

Yet, Newtons laws of motion may help us to at least frame what might be around the corner. On the one hand, there are centripetal trends that might be aggravated and give rise to security concerns a lot sooner than they might otherwise have been expected. On the other, centrifugal forces may result in unexpected problems, such as the collapse of regimes and governments, civil unrest and even war. Europe needs to be prepared for all of these events; COVID-19 shows that we no longer have the luxury of saying big events may never happen.

There may be some comfort in knowing that even before the pandemic, the European Union was already beginning to take its strategic autonomy more seriously in areas like defence, currency and technology. However, COVID-19 emphasises the necessity of European solutions to cross-border crises. This crisis may call for a bold step forward in EU integration underpinned by treaty change, but it may equally result in governments seeking solace in the seemingly comfortable, albeit insufficient, bosom of national sovereignty.

What about the other two horsemen: war and famine? As of today, it seems likely that the EU will emerge from the pandemic before Africa and the Middle East. As Europe implements its economic stimulus package, there will be neighbouring countries that simply lack the medical and sanitation infrastructure to flatten the curve. They will lack the financial resources to kick start their economies too. Many in the EUs wider neighbourhood are already stricken by war, conflict and the aggravating effects of climate change. The crisis could lead to greater poverty and exploitation.

The migration crisis could be exacerbated too, and put additional strain on Europes southern states. The perfect storm of the pandemic, war and human trafficking is already upon us in Libya. Populists inside and outside of the EU may well seize on this issue, too. Furthermore, despite historically low oil prices, the virus could nonetheless significantly damage global food supply chains and undermine much-needed state-backed food subsidies in the poorest countries.

Any fresh or aggravated instability in Europes near and wider neighbours obviously needs to be avoided. This is why in April, a package of 20 billion was put together to support the EUs most vulnerable neighbours. The French President, Emmanuel Macron, has also spoken about debt relief for Africa.

Beyond money, however, we should expect calls for greater EU support, with police and military advice and logistical medical support to intensify. The EU is already on the ground in places such as the Sahel and the Horn of Africa. EU personnel in Mali have even contracted the virus. Yet, COVID-19 could require the mobilisation of different capacities, such as the airlifting of medical equipment to vulnerable countries, the setting up of mobile field hospitals or sharing best practices on how to manage country-wide lockdowns. Fortunately, the EU is uniquely well-placed to handle these tasks, given its more than 20 years worth of the experience in deploying civil, development, humanitarian, diplomatic and military tools in vulnerable countries and regions.

Yet, in dealing with the four horsemen of the Apocalypse, the EU will be up against a number of difficulties. For example, European assistance to Africa will be deployed alongside China, who have the resources and a desire to make amends for being the country where the outbreak began. This will not make aid coordination on the ground any easier, especially as the EU has already warned that medical aid could be instrumentalised for propaganda purposes. Partnerships with NATO, the UN, Japan, South Korea and others will be essential in upholding a genuine multilateral approach to the crisis that beckons in Africa.

However, perhaps the most worrying challenge facing European security right now is rooted in the continents economic recovery. Even though the EU put a number of tools in place in 2016 to enhance security and defence cooperation, years of under-investment in defence capabilities have taken their toll. In this regard, national approaches will not help Europe, and with Permanent Structured Cooperation and the European Defence Fund, there is no need to reinvent the wheel. Governments just need to invest in European cooperation its that simple.

Europes armed forces are playing a heroic role at home, and the way they have repatriated citizens and delivered medical equipment has been truly extraordinary. Yet, the looming economic recovery may take its toll on Europes armed forces and civilian experts - they will be expected to do more with less money. This has to be avoided at all costs. Without well-resourced and motivated civil and military actors, the four horsemen of the Apocalypse could trample all over Europes security.

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The EU must not let the four horsemen of the Apocalypse weaken Europe's security View - Euronews

Reinvigorating the EU’s Strategy Toward North Korea: From Critical Engagement to Credible Commitments – 38 North

Several recent commentaries published on 38 North have addressed the much-needed evolution of the European Union and its member states policy towards North Korea. Some have argued it is time to talk to North Korea and to more strongly support South Koreas policy, while others have advocated multilateralizing US-DPRK negotiations and drafting a Borrell Peace Plan.

Many observers agree that the strategy of critical engagement the European Union member states (EUMS) have pursued for the past several yearsa combination of both incentives and pressurehas been a partial failure. However, what is needed is not just dialogue or idealistic and impractical policies, but rather agreement on concrete and detailed actions that should be taken to advance common European interests. As James E. Hoare recently commented, recommendations should find support at a political level among EUMS, and to do so, addressing the EUMS main concerns is essential.

The EU needs to pivot from a strategy of critical engagement to implementing a more proactive strategy of credible commitments in four areas: political engagement, nonproliferation, implementation of restrictive measures and engagement with the North Korean people. Such a renewed strategy should be highly coordinated, built on the many initiatives already being taken and facilitated by the appointment of a European Union Special Representative on North Korea.

An Enduring Crisis but a Partly Failed Strategy

The North Korean nuclear and ballistic missile crisis is the most serious proliferation crisis the European Union and its member states currently face on the world stage. All phases of North Koreas nuclear weapons program are currently continuing and the country is increasing its tactical and strategic ballistic missile capabilities, mastering new technologies such as solid rocket propellant technology.

This increases the risk of proliferation of missiles and dissemination of technologies. If such capabilities were ever to be present in certain theatres of operations closer to Europe, European states would face unprecedented challenges in terms of force projection and military operations. Avoiding such proliferation is fundamental to the interests and security of Europe.

For sure, the EU strategy of critical engagement has partly failed, and the levers available to the EU and its member states have been considerably reduced along with their diplomatic influence. Thus, Europeans must remain pragmatic and realistic. Engagement is a diplomatic tool, not a strategy, and the key is to define feasible, realistic political objectives and to adopt a strategy to reach them.

On one side, engagement between the US and North Korea at the working level has been limited, and Seouls engagement with Pyongyang has come to a halt despite the Moon governments repeated attempts. On the other side, North Korea has been wary of engagement with the EU because it does not perceive Brussels as a neutral actor or a mediator. Rather than engage constructively with the EU and EUMS, the North has sometimes tried to divide it, openly criticizing some EUMS while sending more conciliatory signals to others.

Wanted: A More Pragmatic and Coordinated EU Strategy

It is essential that the EU gives the challenges on the Korean peninsula the high priority they deserve, recognizing that its contribution will be limited by its lack of leverage. Although coordination with regional partners is essential, coordination at the EU level must be a priority for implementing an independent, but not unilateral, European policy.

The main problem the EU and the EUMS face today is not a lack of resources, but a lack of both political awareness and coordination. Indeed, several initiatives exist at the EU level (at the Council, the Commission and the Parliament), the EUMS level, and among local European actors such as universities and think tanks. This renewed activism must be accompanied by increased coordination through the publication of a strategyusing the model of the EC-DPRK Country Strategy Paper for 20012004based on credible commitments to political engagement, nonproliferation, implementation of international sanctions and engagement with the North Korean people.

An EU Special Representative on North Korea should also be appointed to advance this agenda, raise awareness in Europe of the stake it has in peace, stability and nonproliferation on the Korean peninsula, and facilitate coordination within the EU among the different directorates, between EU member states and with the EUs partners in the region. Its creation would send a strong diplomatic signal that the EU is credibly and proactively committed to protecting its interests.

Political Engagement

The EU and its member states should renew its diplomatic and political engagement with and on North Korea. The EU should pull three levers:

Nonproliferation

Nonproliferation is a widely supported priority of the EU and its member states, a key objective of the EU Global Strategy and an area of internationally acknowledged EU expertise. Three near-term priorities should be:

Restrictive Measures

The European Union and its member states are key actors in the implementation of restrictive measures imposed by the UNSC on illicit North Korean activities. There are two priority areas:

Engagement with the North Korean People

The EU and its member states have a moral and political obligation to promote the well-being of the North Korean population. This can be fulfilled by continuing to:

Conclusion

It is time to adapt the European Union strategy to North Korea, while being aware a consensus must be achieved first among the EUMS. Indeed, convincing them is key, especially when disagreement persists between countriesnot so much on the long-term objectives but on the best implementation strategy. Opening a public debate in Brussels and in EUMS capitals is much needed and must be based on concrete and pragmatic policy recommendations to defend European interests.

This comment draws on a longer report published for the EU Non-Proliferation and Disarmament Consortium in February 2020: From Critical Engagement to Credible Commitments: A Renewed EU Strategy for the North Korean Proliferation Crisis.

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Reinvigorating the EU's Strategy Toward North Korea: From Critical Engagement to Credible Commitments - 38 North

Dont Make Refugees Political Pawns in Turkey-EU Game – The Globe Post

In the midst of theCOVID-19 pandemic, most governments take preventive measures for the benefit of their citizens. Enforcing social distancing and adding emergency procedures have become legitimate state responses to protect national populations.

Long forgotten, however, are those outside the parameters of national belonging, those lacking the right to have rights or the right to access the privileges of citizenship.

On February 27, following the conflict between Syrian government forces and Turkish-backed rebels in Syrias northern province ofIdlib, Turkey opened its border to allow Syrian refugees to travel to Europe. This act of political retaliation was aimed at forcing NATO, especially Europe, to backTurkeyspositionin the Syrian war.

Within days, hundreds of migrants startedmarchingtowards Greece. By February 29, as many as4,000people had tried to cross the border. Three days later, the number had jumped to10,000. Underthe newly formedgovernment of the right-wing New Democracy party, whose law and order approach led to theeviction of several migrant squats in Athens in the summer of 2019, Greece was less keen on welcoming foreigners with open arms.

Some weretear-gassedwhile others were beaten after beingstripped naked. Abuses by Greek security forces were compounded by Greeces decision tosuspendasylum applications for a month. This decision hadlittle or no legal validity,contravening not only the 1951 U.N. Refugee Conventionbut alsoArticle 78(3) of the Treaty of the Functioning of the European Union, which states that provisional measures undertaken when states are confronted with a sudden inflow of third-country nationals are to be adopted by the European Council and not by individual states.

By mid-March, with the COVID-19 pandemic in full force, Turkeyreducedits movement of people towards Greece and began transporting migrants back to Istanbul. While the turmoil at the Turkey-Greece frontier is at a halt for now, it will most likely return in the near future: after all, the 2015 refugee crisis had never come to a complete stop.

A zero-sum game that blames either Turkey or Greece for last months events is derisory. Instead, the situation is under the ethical and legal auspices of the European Union.

In 2015, thenumber of migrants in need of internationalprotectionin the Mediterraneanregionreached record levels, totaling over1,015,000, a546 percentincrease over 2014. Since then, the E.U.s concern has mainly been how to put a lid on the problem.

The 2016E.U.-Turkey Deal specified that in return for 6 billion euros and the promise of the waiving of visa requirements for Turkish nationals, Turkey would take back all the irregular migrants arriving on the Greek islands by sea.

In other words, Brussels paid Turkey to confine migrants to its territory. Apart from the humanitarian issues it raises, from a political and logistical perspective, this decision will be impossible to abide by in the long term. Not only are there over4 million refugeesin Turkey, but given the countys active involvement in Syria, the E.U.-Turkey statement put far too much power in the hands of a state that could easily manipulate the situation when it is convenient. Any time Turkey is displeased with the E.U., PresidentRecep Tayyip Erdogancould pull the open the borders cardfrom his sleeve.

And for anyone following the news, the so-called refugee crisis is hardly a crisis. The volatility at the Turkey-Greece frontier was highly predictable. Erdogan has been consistentlythreateningto open the bordersforyears.

The core of the problem lies less with Erdogan, and more withthe highly contestedDublin Agreement. Taken as the backbone of the E.U.s shared responsibility in asylum matters, theregulationwas adopted in 2003 to determine theresponsiblemember state for asylum applications.

The regulation binds asylum claims to the state of entry. If a migrant enters the E.U. through Greece, they need to claim asylum there and cannot continue to Germany or Norway, for example. It is a practical way in which Northern Europes wealthy states have been protecting themselves from having to accommodate a surge of migrant entries.

Activists, academics, and policymakers havecalled the Dublin regulationunfairfor years. By making geographical location the main criterion for assigning responsibility for asylum, the agreement not only has increased the pressure on the states located at the E.U.s external borders and on the asylum claimants entering those states but also has led to bureaucratic abuses, with people sent back to their country of entry even when the Dublin scheme wasdeferred, as in 2015.

Greece is definitely to blame for how its border forces have treated migrants. But isnt the E.U. also at fault for leaving Greece to deal with the crisis on its own? Wouldnt it be much easier for the Dublin Treaty to be suspended so people can freely move within the E.U. once they have entered and their asylum claims have been processed?

Brussels is fully aware that migrants do not want to settle on its periphery in countries like Greece, which have suffered steepeconomic downturns, where unemployment is still high, and where the systems of refugee reception and integration leave much to be desired. This is why the E.U. seems willing to provide cash payments for border operations rather than assist the countries facing higher entries by equitably dispersing asylum claimants across member states.

To do that, however, would mean that the wealthier states of Northern and Western Europe and those with a higher capacity to absorb migrants and well-established systems of migrant integration, such as Sweden, Finland, and France, would receive more migrants than what they see as their fair share.

The European Union needs to stop treating migrants as political pawns. These are people who have fled wars, people with children and families, and people who have left their entire lives behind. If this is how they are treated at Europes borders, it is perhaps time to ask what European civilization is all about.

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Dont Make Refugees Political Pawns in Turkey-EU Game - The Globe Post

Industry needs an aligned position on the future of the EU OMP Regulation – PMLiVE

In March 2020 the European Commission presented its New Industrial Strategy for Europe, which proposes to move the European Union towards climate neutrality and digital leadership. As part of this overarching approach, which includes measures to keep the EU at the leading edge of innovation, including in healthcare, the Commission is expected to publish a Pharmaceutical Strategy in Q4 2020. This will focus on the availability, sustainability and security of the supply of pharmaceuticals, a need highlighted by challenges around COVID-19. The Pharmaceutical Strategy is likely to include innovation-boosting measures and plans to revise the EU Regulation on Orphan Medicinal Products (OMP Regulation).

EU Pharmaceutical Strategy

The details of the Strategy are still unclear, with a Commission roadmap keenly awaited.

The potential legislation and initiatives have been hotly debated. The European pharma industry body, EFPIA, wants the Commission to support the industry to remain an innovator and world leader. The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) has highlighted funding the role of small and medium-sized pharmaceutical and medical technology companies, and a supportive legal and regulatory framework as top priorities.

EU OMP Regulation Review

The OMP Regulation is widely expected to be included in the Commissions plans. Member states and others have pressed the Commission to amend the current rules due to the perceived impact on prices. Last August, a Dutch health minister threatened to name companies that cannot offer a sensible and transparent explanation for the high prices of OMPs. Bruno Bruins said that OMP prices over 100,000 per year are no longer the exception not because the prices are justified, but because the rules allow them.

Leading voices in healthcare have highlighted incentives intended to stimulate innovation in medicine development as a whole and the perceived link to high prices. The European Public Health Alliance says the current rules delay competition for long periods, allowing companies to set prices as high as the market will bear. In 2017, two serving Dutch ministers wrote in The Lancet that the system is broken companies can ask the price they like.

The Commission is currently evaluating the OMP Regulation. An internal analysis is planned for Spring 2020, ahead of any publication of new OMP proposals. An internal Commission discussion has highlighted concerns with the current Regulation, especially regarding incentives and the diversity of authorised products.

If the OMP Regulation is reopened, we may see a new law proposed by 2021. Meanwhile, the industry and other stakeholders have a window to shape the proposal and say what it should or should not include.

A recent document prepared for the EUs advisory Pharmaceutical Committee gives clues on the Commissions thoughts.

The document undermines claims from industry and others that the Regulation has been a huge success, stating that of 142 OMPs authorised in the EU to 2017, only around 20 can be directly attributed to the OMP Regulation. The briefing questions the impact of the 1bn the EU has invested into rare disease research in the past decade. An assessment of the market exclusivity (ME) provision concludes that the mechanism is fair for OMPs with annual European sales of less than 50m, but OMPs with sales over 100m may have been overcompensated.

The Pharmaceutical Committee is exploring solutions to these challenges, including measures to direct R&D towards unmet needs (such as establishing a list of priority therapeutic areas and amending the definition of orphan diseases). Increasing transparency of R&D costs is being considered, to enable better analysis.

The criteria for OMP designation is also being considered and the Committee has been asked to consider mechanisms to improve access to therapies.

Conclusion

It is always easier to shape EU plans before publication than try to change them afterwards. The Commission values early industry alignment and proactivity rather than defensiveness and criticism of draft proposals.

Companies and the industry must take up this opportunity and tell the compelling OMP story. They must educate decision-makers about OMPs and use data to highlight the wider value of the OMP sector in the EU.

Working together with patients, industry and other stakeholders, the rare disease community has a once-in-a-decade chance to shape the direction of EU and possibly global orphan medicine regulation. Its time to seize it.

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Industry needs an aligned position on the future of the EU OMP Regulation - PMLiVE