Getting Tough on Supplies

Milmo,Sean;

Getting Tough on Supplies

February 2, 2021

By Sean Milmo

Publication

Article

Pharmaceutical TechnologyPharmaceutical Technology-02-02-2021

Volume 45

Issue 2

The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.

Europe will be hoping to see the suppression of the COVID-19 virus in 2021 with a drastic fall in infections, hospital admissions, and deaths. The virus suppression should then trigger an economic recovery, big enough hopefully to save the region from a deep recession.

Editor’s Note: This article was published in Pharmaceutical Technology Europe’s February 2021 print issue.

The ending of the pandemic will enable the European Union and neighbouring countries to move ahead with a legislative agenda aimed at tackling some of the region’s major public health problems. Once COVID-19 has receded to the background, the EU and many national governments in the region will be focusing on how to make sure that they are better prepared for the next pandemic. Now, after the experience of COVID‑19, pandemics are no longer considered to be remote possibilities.

The European Commission (EC), which makes proposals for new legislation and guidelines, has indicated that the EU intends to take a much tougher line on issues like reliability of drug supplies, particularly on essential medicines (1). The new policy could have a major impact on future relations between the EU and national governments, and the industry.

Some of the regulatory initiatives will aim to put right deficiencies that gained prominence during the pandemic. The biggest of these shortfalls is the chronic issue of shortages of medicines, which periodically, even during normal times, become such a serious matter that they can cause local health crises.

The EC is calling it an EU Health Union in which the prevailing ethos will be one of countries working together rather than individually. In fact, the commission will be given much more control than it previously had over EU public health, which traditionally has been overwhelmingly the responsibility of individual member states.

COVID-19 vaccines

Over the thorny issue of supplies of COVID-19 vaccines, which first became available in late 2020, the EC persuaded 27 EU member states in June 2020 to back a €2 billion joint procurement of sufficient doses to meet the needs of the whole of the EU (2).

The only country not to participate was the United Kingdom, which finally left the EU at the end of the year. Instead, the UK reached its own deals with a number of vaccine manufacturers (3). One of the deals struck by the UK was with AstraZeneca, which was developing a vaccine jointly with Oxford University to be manufactured in the UK (3). Another deal was reached by the UK for a vaccine jointly developed by Pfizer and BioNTech of Germany (3).

In January 2021, AstraZeneca and Pfizer/BioNTech announced that they were having to make production changes. Though denied by the companies, these changes could result in their not fulfilling supply contracts—advance purchase agreements (APA)—with the EU on time (4). The announcements of reduced supply came even after the EU had put up money to ensure the companies had sufficient manufacturing capacity (5).

The EC reacted furiously to the announcements, particularly to the news from AstraZeneca, which Health Commissioner Stella Kyriakides said could result in “considerably” fewer doses being supplied in the first quarter of this year (6). The expected reduction is widely reported to amount to 75 million doses out of the 300 million doses with an option for another 100 million in the EU-AstraZeneca deal.

“Pharmaceutical companies, vaccine developers, have moral, societal, and contractual responsibilities, which they need to uphold,” said Kyriakides in a statement (6).

After Pascal Soriot, AstraZeneca’s chief executive, claimed in an interview (7) in January 2021 with the Italian newspaper La Repubblica that the EU contract only committed his company to make its “best efforts” to deliver the agreed supplies on time, the EC demanded that in the interests of transparency AstraZeneca publish the text of its APA (8). The need for more transparency is likely to be a constant theme in the EU’s future demand for greater reliability of drugs supplies.

The text of the contract published on 29 Jan. 2021, with confidential details on prices, costs, and output redacted, confirmed that AstraZeneca had agreed to use its “Best Reasonable Efforts” to manufacture the contracted doses in its manufacturing sites in the EU. These sites comprised facilities in Belgium and the Netherlands and, since when the deal was signed in August 2020 the UK was considered to be technically part of the EU, plants in Oxford and Staffordshire, UK too.

Controlling exports

On the day the contract was published, the European Medicines Agency (EMA) gave conditional approval to the AstraZeneca vaccine for use by all patients over 18 (9). At the same time, the EC published details of a system for authorizing the export of vaccines subject to APAs because of “a risk that vaccines produced in the Union are exported from the Union, in particular to non-vulnerable countries” (10). Such a potential breach of contractual commitments made by pharmaceutical companies could cause shortages and therefore delays in the administration of vaccines to EU patients, according to the commission.

The planned export curbs, together with the information that companies would need to provide to the authorities, were already arousing concern in the industry before their details were published. “It is vital that any measures proposed by the commission do not restrict or have other negative impacts on exports of vaccines or the import of key vaccine manufacturing supplies,” said the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Vaccines Europe in a joint statement on 27 Jan. 2021 (11). “[This is particularly the case] given the importance of global supply chains in delivering vaccines to citizens in Europe and the world.”

The scheme under which vaccine exports are having to be approved by national authorities in consultation with the EC will be in force only until 31 March 2021 (10). The commission has not ruled out an alternative system of control being introduced after that. “The aim is to provide us immediately with full transparency—transparency that until now has been lacking and which Europeans expect,” commented Valdis Dombrovskis, EU trade commissioner, in a press release (12).

COVID-19 vaccine producers are having to tell national authorities, which in some countries are the government’s health ministries, details of their export plans including amounts, destinations, and dates of delivery. In addition, they are being expected to give information about their vaccine exports over the previous three months (10).

Vaccine exports to certain countries, mainly neighbouring non-EU states, are being exempted from the new rules. Sales to international funds to finance supplies to poorer countries are also being allowed. The major exception among the neighbouring states is the UK, which had a vaccination rate of 12% in late January against 2.5% in the EU (13)—a gap which made the commission the target of much criticism by irate EU citizens.

Foundation for improvement

The EC wants to use the lessons learned from the COVID-19 pandemic as a foundation for a legislative programme aimed at improving healthcare in the EU with dealing with medicine shortages and inadequate access to innovative treatments prioritized.

There are a range of underlying causes of scarcities to be tackled—such as parallel trade, shortages of APIs, supply quotas, levels of prices and reimbursements, and even companies’ marketing strategies. Many of the legislative choices could be directed at stronger obligations on industry to ensure supplies, earlier notification by companies of impending scarcities, and enhanced transparency of stocks along supply chains.

However, the COVID-19 pandemic has made clear that the most urgent health policy requirement in Europe is the creation of a system for dealing with vaccine and medicine supplies during major health crises.

Despite its wealth, Europe has been among the regions that has suffered the most from COVID-19. By early 2021, it had a cumulative total of approximately 20 million cases and 500,000 deaths, with the UK having the highest death total of over 100,000 in January 2021, followed by Italy with 85,000 and France 73,000 (14).

The EC has been looking at ways of extending supply systems during emergencies to cover not just medicines but other essential products, while at the same time ensuring they are highly secure and resilient. It has been considering the feasibility of combining with non-EU members of the World Trade Organization to set up more coherent global supply chains (1).

Without some sort of solution, it will not just be Europe that will be in danger of descending into trade wars over supplies of vaccines.