Health Brief, powered by European Diabetes Forum: The parallel (pharma) universe
A ruling by the EU’s top court last week reopened a portal to the mysterious world of parallel trade in drugs.
Parallel imports of drugs are admittedly one of the most complex topics a health reporter can cover.
This is why journalists at EURACTIV’s health hub were hardly surprised that only a handful of highly specialised health media actually reported on the latest case involving parallel trade.
Last Thursday (25 November), the European Court of Justice (ECJ) ruled that the automatic expiry of the marketing authorisation (MA) of medicinal products does not have an effect on the parallel import licence (PI) of the same product.
Great, but what does that mean in practice?
In a nutshell, you are into parallel trade if you buy medicine products in one member state and sell them in another one at a higher price just to make a profit from the price difference.
The EU allows these parallel imports between member states on the basis of the freedom of movement of goods, an essential principle regulating the single market.
So, this process is lawful, regulated – member states may even restrict the parallel trade in certain cases, for instance – and contributes to part of the medicines supply chain in the single market.
In 2020, the share of parallel imports amounted to 2.8% of the total medicines market in the EU, with a turnover of €5.9 billion.
The parallel trade starts with the issuing of a marketing authorisation (MA) for a certain medical product and with the subsequent request for a parallel import (PI) license for the same product – if it is already covered by a MA in another member state.
The PI license request mirrors the marketing authorisation in basically every component but specifies that applicants are not the holders of the MA.
For quite a while, the big question related to parallel trade has been: what happens to the PI license when a drug manufacturer withdraws the MA?
This situation is not that uncommon, as a company involved in parallel trading may keep doing their business in a market where the drug manufacturer may no longer be interested in placing its product – for instance, if the profit margin is too low or they want to introduce a new drug in that market.
However, the ECJ case law on parallel trade established that if an MA has been withdrawn from the country, the PI license may continue, meaning that traders can continue to import and sell that drug as a normal good.
Of course, it is not quite the same as before: PI licensers have to provide all the pharmacovigilance information that is normally produced by the marketing authorisation holders, for instance.
What remained open before last week’s court ruling – yes, we finally got there – was the situation when a marketing authorisation simply expires.
According to the European Medicine Agency (EMA) rules, a marketing authorisation is valid for five years and expires if the holder decides not to renew the application.
This time, the ECJ made it clear that “the automatic expiry of the parallel import licence for a medicinal product solely on the basis that the MA of reference has expired, without carrying out an examination of the risks arising from that product, goes beyond what is necessary to protect the health and life of humans”.
Kasper Ernest, the secretary-general of the EU’s association of parallel importers (Affordable Medicines), explained that the ruling ensures that, when manufacturers decide to no longer market their products and let their authorisations expire, PI will be able to continue to supply patients in that country via the internal market.
So, the PI license outlives its twin MA when the latter expires. This means that, as long as there is a market for that product somewhere in Europe, the PI companies can continue their business.
This was considered a victory by the sector and, as proven by the previous case law, it is not the first time that the Luxembourg court has supported parallel trade as a way to have an impact on lowering prices and giving more choice to the final consumers.
However, parallel trade remains a controversial practice, with drug manufacturers suggesting that it can cause medicine shortages in Europe.
But above all, pharmaceutical companies claim parallel trade deprives the industry of additional resources to fund research and development (R&D).
Indeed, the pharmaceutical sector in Europe is R&D-driven, which means manufacturers prefer to compete by focusing on innovation rather than on prices.
According to Kasper Ernest, the COVID crisis highlighted that the real causes of shortages lay primarily with manufacturing.
“In fact, 52% of parallel exports come from the 10 highest-income countries, with France, Germany, and the UK in the top three, and export restriction legislation is in place in the vast majority of EU member states,” he told EURACTIV.
What is clear after this round-up of what happened in Luxembourg is that the mysterious parallel (medicine imports) world is enough to give anyone a headache.
So, the moral of the story here? If you want to avoid popping a (parallel) paracetamol to deal with this (and other mind-bending) subjects, be sure to follow EURACTIV updates.
A message from the European Diabetes Forum
EUDF has been created to bring together multiple stakeholders from across the diabetes landscape in Europe. The mission of EUDF is to ensure that policy action can be directed towards driving better diabetes care at national and European level. Continue Reading >>
Emer Cooke in the house
On Tuesday (30 November) Emer Cooke, executive director of the European Medicines Agency (EMA), reassured health MEPs that the EMA is prepared to deal with the current challenges posed by the pandemic.
The debate with the health committee focused on COVID-19 vaccines, recent developments in COVID-19 therapeutics and the agency’s capacity to deal with current and future challenges.
The agency already has guidance for manufacturers that plan to modify vaccines to address variants in place. The agency also has a legal framework to authorise adapted vaccines more quickly, which would ensure they are approved within a 3-4 months period.
The Parliament and Council also recently reached a deal for a stronger role for the agency following lessons learned from the pandemic. With regard to its capacity to deal with its reinforced role, EMA’s Cooke informed MEPs that the agency is still evaluating the impact of its new tasks.
On Monday (29 November), the EU Council and the European Parliament concluded a political deal to renew the mandate of the European Centre for Disease Prevention and Control (ECDC). With this updated mandate, the EU aims to strengthen the ECDC’s work in the areas of surveillance, early warning, preparedness and response. This planned update of the ECDC mandate is part of a broader European Health Union package.
A report by the European Parliament’s health (ENVI) committee on the implementation of the EU’s pharmaceutical strategy was endorsed by the plenary on 24 November by a huge majority, with 527 votes in favour, 92 against and 70 abstentions.
The strategy was adopted a year ago, but “the world has changed,” Dolors Montserrat, Spanish Christian-democrat MEP and environment committee rapporteur for the file, pointed out. “We need to bring our laws and incentives up to date,” she said.
The ENVI Committee subsequently came up with a report with proposals to make medicines more available and affordable, boost transparency on prices and promote joint EU public procurement.
As of Tuesday (30 November), 44 confirmed cases of SARS-CoV-2 Omicron VOC have been reported by eleven EU and European Economic Area (EU/EEA) countries (Austria, Belgium, Czechia, Denmark, France, Germany, Italy, the Netherlands, Portugal, Spain and Sweden). All confirmed cases have a history of travel to African countries, with some having taken connecting flights in other destinations between Africa and Europe.
The B.1.1.529 variant, first detected in southern Africa, is the most divergent variant that has been detected in significant numbers during the pandemic to date, raising serious concerns that it may significantly reduce the effectiveness of vaccines and increase the risk of reinfections ECDC reported on Friday (26 November).
To try to control the spread of the new variant, the EU has announced it will halt air travel from the southern African region, Commission chief Ursula von der Leyen said on Friday (26 November).
The EU’s disease centre, the ECDC, recommended applying sanitary measures immediately and pursuing efforts in vaccinating EU citizens on Wednesday (24 November) to avoid a “very high COVID-19 burden“. The continent’s death toll could top 2.2 million this winter if current trends continue, the World Health Organisation (WHO) warned on Tuesday (23 November).
EU residents will need to have COVID-19 vaccine booster jabs if they want to travel to another country in the bloc next summer free from tests or quarantines, the Commission proposed on Thursday (25 November).
On Thursday (25 November), the EMA’s human medicines committee (CHMP) recommended granting an extension of indication for the COVID-19 vaccine Comirnaty (Pfizer-BioNTech) to include use in children aged 5 to 11. It is the first vaccine to be approved for children under 12 years old.
The news came a day after WHO published the statement on vaccination for children and adolescents where it was stated that children and adolescents tend to have milder disease compared to adults unless they are in a group at higher risk of severe COVID-19. It, therefore, concluded that it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers. However, it was also noted that vaccination in this age group may reduce transmission from children and adolescents to older adults, and may help reduce the need for mitigation measures in schools.
Since October 2020 ongoing worldwide discussion on IP waiver for COVID-19 vaccines was hoped to finally reach a breakthrough at the World Trade Organization (WTO) meeting set for Tuesday (30 November) in Switzerland.
But as news about the new COVID-19 variant surged across, the meeting was cancelled, leaving the puzzle unsolved.
In October 2020, India and South Africa proposed to temporarily waive several sections of the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) – an international legal agreement between all the member nations of the World Trade Organization (WTO) to ensure reaching equity in the distribution of COVID vaccines.
It was backed by the USA while the EU initially opposed the waiver but has since tabled a counter-proposal to use flexibilities in existing WTO rules, arguing that waiving IP rights without know-how and technology transfer won’t solve the issue.
Member states of the WHO have reached a tentative consensus to negotiate a future agreement on preventing pandemics, bridging the gap between sides led by the EU and United States, diplomats said on Sunday (28 November).
WHO´s Scientific Advisory Group for the Origins of Novel Pathogens (SAGO) held its first meeting on Tuesday (23 November). The group agreed to meet frequently and focus urgently on advising on the overarching framework to study the emergence of novel pathogens, as well as to rapidly undertake an assessment of the current understanding of the origins of SARS-CoV-2.
EURACTIV spoke to Bente Mikkelsen, the director of the non-communicable disease department at the WHO headquarters if she feels optimistic about diabetes treatment and where it is going.
“What gives me hope is that we know what to do,” she said, adding that we have “good guidelines” on how to increase physical activity, how to improve uptake of healthy food, and how to treat and control diabetes, as well as how to strengthen health systems to respond to the disease. Read the full interview here.
On Tuesday (30 November), a new report marking World AIDS Day was published jointly by the ECDC and WHO’s regional office for Europe. It showed a 24% drop in the rate of newly diagnosed HIV cases between 2019 and 2020. This drop is largely due to reduced HIV testing during 2020 as a result of COVID-19 restrictions and disruptions to services.
On Wednesday (24 November), the WHO published an HIV drug resistance report which revealed that, in 2020, 64% of focus countries (aka, countries with a high burden of HIV infection) had national action plans to prevent, monitor and respond to HIV drug resistance. These plans are informed by the global action plan on HIV drug resistance 2017–2021, a multi-stakeholder plan coordinated and published by WHO.
Archbishop calls for vaccination, finally. As the number of COVID-19 cases and deaths continues to rise in Croatia, the Catholic Archbishop, at last, called on believers to take the vaccine. By Zeljko Trkanjec | EURACTIV.hr
Spain places new restrictions on flights from southern Africa. Travellers from several African countries will now have to show a COVID-19 negative test when entering Spain even if they have been fully vaccinated, although no cases of the Omicron variant have been detected in the country, EURACTIV’s partner EFE reported. By Fernando Heller | euroefe.es
Thousands gather to protest pandemic measures in Dublin. Thousands of people gathered in Dublin on Saturday (27 November) afternoon for a demonstration against COVID-19 restrictions. The group marched through the city before holding a rally. By Molly Killeen | EURACTIV.com
Ireland may roll out vaccinations to young children in New Year. The government may introduce vaccinations for primary school-aged children, with a potential start date in the New Year, Taoiseach Micheál Martin has said. By Molly Killeen | EURACTIV.com
Masks back as ministers try to control Omicron. Mask wearing will be mandatory on public transport and in shops as part of a series of new measures to control the spread of the Omicron variant of COVID. By Benjamin Fox | EURACTIV.com
Swiss support COVID certificates and better working conditions for care workers. After an emotional campaign and signs of radicalisation, a large majority of Swiss people voted in favour of a law providing the legal basis for using the COVID certificate in Switzerland. Moreover, a majority supported a call for better working conditions for care workers. By János Ammann | EURACTIV.com
Portugal adopts new restrictive measures despite the high vaccination rate. New measures like making vaccinated people show a negative test to enter sports venues and cultural events are needed despite the country’s high vaccination rate, said Prime Minister António Costa. Portugal “is not as well” as I wanted, he added. Lusa.pt
Portugal’s high vaccination rate makes Commission confident about economic recovery. The European Commission remains optimistic the Portuguese economy will recover quickly, especially as the COVID-19 vaccination rate in the country is so high. By Ana Matos Neves and André Campos | Lusa.pt
Poll: Greeks back mandatory vaccination. Most Greeks (66%) favour extending mandatory vaccination to groups of workers who come into contact with a lot of people, according to a poll for Greece’s Skai TV. However, making vaccination obligatory for the country’s police remains a challenge for the conservative government. EURACTIV.gr
Greek church cannot guarantee it will follow latest COVID-19 measures. “People who work or volunteer in the Holy Churches have neither the capability nor the power of a public good as the police do,” the Holy Synod announced on Monday (22 November) as the number of COVID-19-related deaths has skyrocketed. By Matthaios Tsimitakis | EURACTIV.gr
France says no to lockdowns, boosts vaccination campaign instead. France will not go into lockdown or under curfew and will speed up its vaccination campaign to slow the increase of COVID-19 cases amid a European fourth wave. By Clara Bauer-Babef | EURACTIV France
Macron calls for ‘not giving in to lies’ as protests against mandatory jabs in Guadeloupe unfold. On the sidelines of a trip to Amiens in northern France, President Emmanuel Macron has called for “calm and public order” in Guadeloupe as the French island in the Caribbean is shaken by a protest movement against the mandatory vaccination of healthcare workers. By Mathieu Pollet | EURACTIV.fr
Albanian COVID-19 vaccine rates continue to lag. Albania is one of the countries with the lowest vaccination rates in Europe, with just 33% of the population fully vaccinated and 37% with one dose, according to Our World in Data and reported by Exit.al. By Alice Taylor | exit.al/en
Italy to impose lockdown for unvaccinated and boosters for 18-39 age group. The Italian Council of Ministers voted on Wednesday (24 November) to reduce the validity of the COVID pass from 12 to nine months and only allow the vaccinated or those who have recovered from the virus to access bars, restaurants, and other leisure facilities. By Eleonora Vasques | EURACTIV.com
Italians to get boosters five months after second shot. The minimum period to get a booster shot after taking two doses of the Pfizer/BioNTech, Moderna or AstraZeneca vaccine, or the Johnson & Johnson single-dose, will be five months instead of six, according to a letter published Tuesday (23 November) by the director-general of disease prevention at the health ministry, Giovanni Rezza. By Eleonora Vasques | EURACTIV.it
Lockdown on the horizon for Slovakia after president’s emotional appeal. Slovak president Zuzana Čaputová urged the ruling coalition to quickly pass a measure to impose a total lockdown in an impassioned plea after visiting a COVID-19 hospital ward in Bratislava on Tuesday (23 November). By Michal Hudec | EURACTIV.sk
Austria warns of hotchpotch in COVID-19 certificate rules across Europe. Austria has warned that the different measures taken by EU countries to tackle the pandemic could lead to fragmentation in how the COVID certificate is used. According to European Affairs Minister Karoline Edtstadler, the COVID certificate must be strengthened to ensure a harmonised approach across the EU. By Oliver Noyan | EURACTIV.de
HELSINKI | TALLINN
Finland responds to Estonia’s call for COVID-19 vaccines. Finland will deliver 130,000 doses of the Pfizer/BioNTech vaccine to Estonia by the end of November after it requested help from other EU countries, Finland’s social affairs and health ministry announced. In return, Estonia has promised to send the same amount of vaccines back to Finland in February next year. By Pekka Vanttinen | EURACTIV.com
Petition for mandatory vaccination launched in Czechia. Czech scientist Peter Šeba from the Academic of Science has launched an online petition for mandatory vaccination. After a few days, it gained around 2,500 signatures and sparked a debate about this sensitive issue. So far, the Czech government has refused to opt for mandatory vaccination. By Aneta Zachová | EURACTIV.cz
29 November – 1 December | World Health Assembly
1 December | World AIDS Day
3 December | International Day of Persons with Disabilities