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#EAPM - European innovation in a time of #COVID-19

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Before we get into what’s been going on of late during these testing times (pun intended) here’s a quick reminder that registration will close very soon for next week’s virtual conference, which takes place on Tuesday 30 June, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Entitled Maintaining public trust in the use of Big Data for health science in a COVID and post-COVID world, it acts as a bridging event between the EU Presidencies of Croatia and Germany.

Alongside our many great speakers, attendees will be drawn from leading experts in the personalised medicine arena – including patients, payers, healthcare professionals, plus industry, science, academia and the research field. We’ll be discussing, at some point during the day, most or all of what we’ll be talking about below.

Here is the link to register, but be quick!

In the meantime, if you get the opportunity, it may well be worth taking a look at the European Commission’s Innovation Scoreboard. Innovation is certainly something Europe is generally great at - although it does vary across member states and the implementation could certainly be better. 

Obviously, it’s of key interest to EAPM and its members and partners, not least because innovation in healthcare is something we continuously work hard to promote and encourage.

The link for the site can be found here, but here’s a general idea of what to expect.

So, what is the European Innovation Scoreboard (EIS)?

The annual EIS provides a comparative assessment of research and innovation performance in EU Member States, other European countries, and our regional neighbours.

Its aim is to let policymakers assess relative strengths and weaknesses of national research and innovation systems, track progress, and identify priority areas to boost innovation performance.

The EIS covers the EU-27 plus Iceland, Israel, Montenegro, North Macedonia, Norway, Serbia, Switzerland, Turkey, Ukraine and the UK. It also looks at a limited number of global indicators from, for example, Australia, Brazil, Canada, China, India, Japan, the Russian Federation, South Africa, South Korea, and the US.

Currently, based on scores for 27 separate indicators, including innovation activities in companies, investment in research and innovation, and human resource and employment elements, EU countries fall into four performance groups:

Innovation leaders are Denmark, Finland, Luxembourg, the Netherlands, and Sweden, all of whom perform significantly above the EU average;

Strong innovators are Austria, Belgium, Estonia, France, Germany, Ireland, and Portugal, all of which perform above or close to the EU average.

Moderate innovators are Croatia, Cyprus, Czech Republic, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Slovakia, Slovenia, and Spain. These countries show an innovation performance below the EU average.

And modest innovators - which is putting it gently - are Bulgaria and Romania. Both countries come in below 50% of the EU average.

The EIS 2020 shows an improved overall innovation performance. For the EU as a whole, it increased by 8.9% between 2012 and 2019. Over the same period, the performance improved for 24 Member States, most notably for Lithuania, Malta, Latvia, Portugal and Greece, where the innovation performance grew by more than 20%.

Compared to the last year's edition, performance has improved for 25 member states, most notably for Cyprus, Spain, and Finland.

There’s plenty of more specific sector information online at the link above, so do take a look if you’ve the opportunity.

Progress - and lessons learned

We mentioned in our last update that the HTA discussions in Council have taken a hit from for the COVID-19 crisis, yet in France at least, this is apparently not the case.

Its Haute Autorité de Santé (HAS) claims that COVID-19 has “hampered neither the arrival of [innovative medicines] on the market, nor their evaluation by the HAS”.

It seems that manufacturers are using the new fast-tracking applications from HAS more often, with 22 applications filed this year so far, compared to 16 in the entirety of last year.

HAS says it is also writing opinions more quickly. Good to know.

Meanwhile, generics lobby Medicines for Europe has brought out a new paper on the lessons learned from the COVID-19 pandemic in Europe.

It seems that many of the shortcomings came from within the EU, with the biggest issue being the countries’ unilateral actions. For example, slamming shut borders within the bloc caused supply issues, and hoarding.

The EMA couldn’t deal with the dramatic increase in demand for ICU medicines, while the ECDC was slow to share epidemic forecasts, which didn’t help medicines producers with predictions.

The upshot is that Medicine for Europe has now called on the Commission to create an EU pandemic preparedness plan so Europe won’t have to face the same obstacles in future.

For example, it has suggested diversifying supply chains and changing reimbursement and procurement policies, more regulatory flexibility, and more digital reporting.

Second wave fears

Much has been said about second waves and local breakouts, not least in the last couple of days after the UK - following in the footsteps of the likes of Germany - saw Prime Minister Boris Johnson announced the rowing back of many restrictions and the re-opening of a wide range of business permissible from 4 July.

Realistically, there will be more local lockdowns and if scientists are to be believed there will certainly be some kind of a second wave. So some governments and, of course, many members of the general public are understandably a little nervous.

Europe’s Health Commissioner Stella Kyriakides this week said that the Commission will publish a communication on the second wave on 15 July.

Worryingly, some member states that didn’t get hit the worst by the coronavirus initially, such as Romania and Bulgaria, are now reporting localized outbreaks. 

At the same time, Greece and Denmark are warning about possible second waves, while Portugal’s Prime Minister António Costa has imposed some stricter rules. 

But as mentioned, Germany’s facing its own new challenges, with numerous localised outbreaks. EAPM’s supporter and German MEP Peter Liese has said he was “shocked” when his constituency was hit. 

Liese thinks some indoor venues should be closed. For example, cinemas and restos. Also, he feels that citizens should be unable to use places such as nonessential shops for longer than 15 minutes,. Masks should be an absolute requirement, he believes.

If were not careful, we will have a general increase,” he said.

While we have the spotlight on Liese, it is rumoured that while his party the EPP will get the chair of the European Parliament’s Cancer Committee, he doesn’t want the job personally.

The Renew Europe party will get the lead rapporteur role on the Cancer Plan - probably in the person of MEP ronique Trillet-Lenoir.

Immunity questions for vaccines

The last item today involves vaccines. And it turns out that vaccine developers dont know the level of immunity needed to protect people against coronavirus. This means that it is difficult to estimate their version of a vaccine’s success chances, with the higher level of immunity needed meaning the fewer number of vaccine efforts will be successful.

This latter observation came from Imperial CollegeRobin Shattock while he was addressing the UK’s House of Lords Science and Technology Committee earlier in the week.

He said: “I think our chances are high, but I think we shouldnt be over hyping the potential success.”

University of Oxford Professor Sarah Gilbert however said that it depends on the purpose of the vaccine. She said: “The aim is to protect the population and that doesnt mean that the vaccination has to be 100% effective. Even with the 50% efficacy, we could actually go a long way to protect the population.”

So that’s all for this week. Look out for our monthly newsletter which is due shortly and, once again, do take this late opportunity to register for Tuesday’s virtual conference, if you haven’t done so already.

All the best for the weekend and here is the link to register.

COVID-19

US supports WTO waiver of Intellectual Property on COVID-19 vaccines

Catherine Feore

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In a surprise announcement by the US Trade Representative Katherine Tai has announced that the US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic and will “actively participate in WTO negotiations to make this happen”.

The USTR said that extraordinary times and circumstances called for extraordinary measures. 

In March, European Commission trade spokesperson Miriam Garcia Ferrer told journalists that the current view of the European Union was that the problem of access to vaccines would not be resolved by waiving patent rights. 

Garcia Ferrer said that the real problem lay in insufficient manufacturing capacity to produce the required quantities. The European Commission very much welcomed the statement of WTO Director-General Ngozi Okonjo-Iweala who has said there should be a third way to broaden access to vaccines through facilitating technology transfer within the multilateral rules, to encourage research and innovation while at the same time allowing licensing agreements that helped to scale up manufacturing capacities. 

South African/Indian proposal

WTO members recently debated the proposal submitted by South Africa and India calling for a waiver from certain provisions of the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement in relation to the “prevention, containment or treatment” of COVID-19. Since its submission, the proposal has received further support from Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt and the African Group within the WTO. 

The proponents argue that the waiving of certain obligations under the agreement would facilitate access to affordable medical products and the scaling-up of manufacturing and supply of essential medical products, until widespread vaccination is in place and the majority of the world’s population is immune. 

However, there is a lack of consensus and divergence on what role intellectual property plays in achieving the goal of providing timely and secure access to safe, efficacious and affordable vaccines to all. Proponents argue that existing vaccine manufacturing capacities in the developing world remained unutilized because of IP barriers. Other delegations asked for concrete examples of where IP would pose a barrier that could not be addressed by existing TRIPS flexibilities.

The outgoing chair of the TRIPS Council, Ambassador Xolelwa Mlumbi-Peter of South Africa, said swift action is urgently required to help scale up COVID-19 vaccine production and distribution. She called on members to shift gears and move towards a solution-oriented discussion.

The next regular TRIPS Council meeting is scheduled for 8-9 June, but members agreed to consider additional meetings in April in order to assess potential progress on the IP waiver discussion.

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EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated

EU Reporter Correspondent

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EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co., Ltd. The EU applicant for this medicine is Life'On S.r.l.

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies. These studies suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease.

EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.

EMA will assess the compliance of COVID-19 Vaccine (Vero Cell) Inactivated with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

EMA will communicate further when the marketing authorization application for the vaccine has been submitted.

How is the vaccine expected to work?

COVID-19 Vaccine (Vero Cell) Inactivated is expected to prepare the body to defend itself against infection with SARS-CoV-2. The vaccine contains SARS-CoV-2 that has been inactivated (killed) and cannot cause the disease. COVID-19 Vaccine (Vero Cell) Inactivated also contains an ‘adjuvant’, a substance that helps strengthen the immune response to the vaccine. 

When a person is given the vaccine, their immune system identifies the inactivated virus as foreign and makes antibodies against it. If, later, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be ready to defend the body against it.

What is a rolling review?A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency. Normally, all data on a medicine or vaccine’s effectiveness, safety and quality and all required documents must be ready at the start of the evaluation in a formal application for marketing authorization. In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available from ongoing studies. Once the CHMP decides that sufficient data are available, the company can submit a formal application. By reviewing the data as they become available, the CHMP can come to an opinion on the medicine’s authorisation sooner.During the rolling review, and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force (COVID-ETF). This group brings together experts from across the European medicines regulatory network to advise on the development, authorization and safety monitoring of medicines and vaccines for COVID-19 and facilitate quick and coordinated regulatory action.

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Ukraine's capital Kyiv eases coronavirus restrictions

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Ukraine's capital Kyiv on Saturday (1 May) eased tough restrictions imposed last month to prevent the rapid spread of the new coronavirus.

In early April, Kyiv limited its public transport services, closed schools and kindergartens, theatres and shopping centres, and banned spectators from sporting events.

Starting from Saturday, the capital will allow the operation of transport, cafes and restaurants, although passenger and customer numbers will be restricted. Wearing masks is still mandatory in transport and public places.

Shopping malls and sports clubs were able to reopen on Saturday, while schools and kindergartens will open from 5 May, local authorities said.

Last month, Kyiv recorded some of highest numbers of new infections among Ukrainian regions, but new cases dropped significantly last week.

Ukraine has registered more than 2 million infections and 44,436 deaths since the pandemic started last year.

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