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Transformational Legislative Changes for European Pharma: What You Need to Know

The pharmaceutical landscape in the European Union (EU) is on the brink of a significant transformation with the introduction of major legislative changes. This proposed overhaul has been met with a mix of anticipation and apprehension as it aims to reshape how pharmaceuticals are regulated, developed, and accessed within the EU. In this article, we delve into the key highlights and potential implications of this new legislation for the European pharma sector.

Reshaping Pharma Regulation in the EU

This year, the European Commission has submitted a draft legislation that aims to bring significant alterations to the regulation of the pharmaceutical sector. This move came after a series of intense debates that have surrounded the future of the European pharma industry.

Let’s take a closer look at the key points of the draft document.

Reduced Minimum Period of Regulatory Protection

Central to the proposed legislation is a reduction in the minimum period of regulatory protection for innovative medicines. The draft suggests a reduction from the existing 10 years to 8 years, but with provisions for extensions based on specific criteria. This shift aims to find a balance between incentivizing innovation and ensuring broader patient access. Pharmaceutical manufacturers have the opportunity to prolong safeguarding measures for up to 12 years through several strategies: introducing medications across all member states, tackling medical gaps, conducting relative clinical trials, and exploring novel therapeutic applications.

It’s widely recognized that bigger member countries tend to have an advantage in getting certain medicines faster. The objective of legislators is to transition towards an intelligent incentive framework that replaces the existing across-the-board protection for medicines within the single market. This new system ensures that the degree of protection your products receive in the single market aligns with your commitment to advancing market accessibility and affordability.

Accelerating the drug authorization process

The proposed changes will simplify the regulatory framework. Accelerating the authorization process for new medicines aims to reduce the time between submission and market approval.

The European Commission wants to ease the impact on biopharma firms by modernizing regulations and expediting drug authorization. The proposal shortens the European Medicines Agency’s assessment period to 180 days (from 210), and the Commission’s drug approval time to 46 days (from 67). These changes will cut the current average of 400 days for market approval after submission. EMA will be given a 150-day period to review medicines that are considered very important for public health. Additionally, they will use special testing methods called “regulatory sandboxes” to test new ways of regulating new treatments in everyday or practical situations.

Introduction of Transferable Antimicrobial Vouchers

Addressing antimicrobial resistance is another critical aspect of the proposed legislation. The introduction of transferable antimicrobial vouchers seeks to provide an additional year of data protection against competition, incentivizing the development of vital antimicrobial treatments.

Catalog of Vital and Essential Medications

The Commission is going to create a vital medicines catalog within the EU. Authorities will give advice to companies and others involved to make the supply chains of those medicines stronger. The Commission will have the power to take actions that make these supplies more secure.

According to European Commissioner for Health and Food Safety, when instances of critical shortages arise, they will have the capacity to collaborate with the EMA to efficiently address this challenge. Most likely, the list of critical medicines will be ready by the end of this year. After that, the EU will be able to impose legally binding responsibilities on companies. This might involve stipulating the availability of certain medicines, potentially through the creation of mandates for the maintenance of contingency stockpiles.

EU Pharma Industry Risks and Concerns: Balancing Innovation and Access

While the suggested alterations have received industry approval, there are also worries and doubts. We think it is necessary to consider them as well.

There are critique voices that the current proposals risk hampering research and development efforts in Europe, while overlooking patient access to medicines. This can affect the development of breakthrough treatments. According to critics, the new rules can hurt innovation if a medicine isn’t available in all countries within two years. This is a big problem and makes things too hard for companies.

The European Commission’s intention to encourage the influx of generics and lower prices may raise concerns among developers of innovative medicines, potentially leading to their exit from the EU.

At the same time, questions arise whether the special vouchers for antimicrobial medicines really make companies want to create important treatments. People are also worried this might affect fair competition among companies. And there’s also worry about keeping medicines safe and working well. Finding the right balance between speed, evaluation and ensuring patient access remains a challenge.

What’s Next?

The release of the draft signifies the completion of the initial phase to shape the legislation. Before the text becomes final, both the European Parliament and the Council will have their input. The document could still undergo further modifications, and it remains uncertain whether the text will be fully approved by the end of the current Commission’s term, which concludes on October 31, 2024.

Uncovering the Rich History of the Hague Convention

We call it The Hague in English, Den Hag in its native Dutch, but often La Haye, using French, the traditional language of international diplomacy.

In any language, this is the city where a historic international accord was created in 1961, affecting to this day the flow of vital documents among countries. This accord is called The Treaty of the Hague Convention of 1961—aka The Apostille Convention.

Recently, the Hague also became home to the European Medicines Agency, producing many of the documents relative to pharmaceutical export.

In the shorthand of global document authentication, most things boil down to “Hague” and “Non-Hague.” This designates whether the origination and destination countries of any given document are signatories to the Treaty of the Hague Convention of 1961. If it was, one official stamp, issued by any member country, will authenticate a document for use in any other member country. Today, there are more than 100 signatory nations.

It was only natural in 1961 that nations of the world would turn to The Hague Convention to streamline the approval process for cross-border documents. Natural, because long before there was a United Nations or even a League of Nations, there already existed a structure for international negotiation.

A little digging reveals a rich and storied history of the Hague Convention and one with roots in the searingly relevant issues of arms control and rules of engagement for warfare.

The first Hague Convention convened in 1899, at the behest of Russia’s Tsar Nicholas II, to restrict the damages of war. As increasingly lethal weaponry affected civilian populations and civil infrastructure in the decades following the fall of the Napoleonic Empire and during the expansion of European colonialism, leaders sought to limit rules of engagement. Almost quaint by modern standards, but deadly serious in its time, was the practice of dropping explosives from flying balloons. Another hotly debated topic was the advent of exploding bullets. Protection of civilian targets and civil infrastructure also filled the agenda at the first Hague Convention.

Results were inconclusive, unfortunately, and a follow-up conference was scheduled for 1907 which also failed to achieve consensus. The next Hague convention, scheduled for 1915, was canceled by the First World War, by which time aircraft had replaced balloons.

Fast forward to 1961. International conflict resolution had now passed to the United Nations, formed after WWII and headquartered in New York City. But the Hague convened for a different purpose: to streamline document legalization, a process critical to international trade of all types. They came up with apostille, a French term for “little stamp.” Suddenly, miles of red tape were removed for companies and individuals to use and apply their documents.

Pharmaceutical companies, for example, could manufacture drugs in one country, brand them in conformity with its corporate headquarters, and pursue distribution throughout the world.

Standard documents, such as powers-of-attorney and bills of lading, were suddenly streamlined when transiting among Hague countries.

Documents for adoption, intellectual property rights, work-abroad visas, and criminal background checks were similarly impacted.

Today, countless multitudes of companies and individuals benefit from the achievement of the Treaty of the Hague Convention of 1961. A subsequent Hague Convention treaty, crafted in 1996, added legal protections for children. Affecting cross-border adoptions and the threats of human trafficking, this was broader in scope than the previous Hague Conventions which had treated this critically important topic.

Perhaps it is the Convention’s voluminous handbook that states best the lasting legacy of this obscure treaty:

The Apostille Convention is the most widely ratified and acceded to of all the Conventions adopted under the auspices of the Hague Conventions. It is in force in over 100 States from all major regions representing all major legal systems of the world, making it one of the most successful international treaties in the area of international legal and administrative cooperation.

Even after 60 years, the work of the Hague Convention remains incomplete. Despite its wide application among more than 100 nations around the globe, numerous countries remain non-signatories, examples including Canada, China, Egypt, and others. The most recent signatories, welcomed in 2021, include Singapore and Jamaica.

6 Tips for Apostille or Document Legalization

When marketing and selling medical devices, pharmaceutical products, cosmetics or foods outside the U.S., your company will be required to have certain regulatory, quality or supporting technical documents authenticated either by apostille or by consular legalization through the embassy of the target country.

The health ministries of countries require assurances that the products entering are safe, effective and in conformance with current Good Manufacturing Practices (CGMPs). Thus, companies are required to submit for review to the ministry copies of the company’s U.S. Food and Drug Administration (FDA) approval certificates such as:

Certificate to Foreign Government (CFG),
Certificate of Exportability (COE);
Certificate of Pharmaceutical Product (CPP)); and its
International Organization for Standardization (ISO) certification; or
Free Sale Certificate (CFS) to document that its products are free from defect, disease or harmful nature.

Note: CFG is used by FDA to describe a type of certificate referred to in other countries as a CFS.

To confirm authenticity, these certificates need document legalization, authentication or apostille within the U.S. depending on the national ministry’s requirements. To do this, one can handle it in-house or utilize the expertise of a service specializing in efficiently handling this process.

If you choose to handle it on your own, these six quick tips can help you through the document legalization process!

Notified Bodies Update

Even though the EU MDR was postponed until May 2021, the dwindled-down list of Notified Bodies suggests Regulatory Affairs professionals might not want to kick the can too far down the road.

For those looking at the upcoming IVDR, the situation is even bleaker. The IVDR has not yet been postponed, still facing a May 2022 effective date.

“…with only three notified bodies designated against the IVDR so far, potential delays in further designations because of COVID-19 and social distancing could be a real problem for a diagnostics industry that has been preventing from moving towards compliance when there are so many unfinished structures and documents”

@MedtechAmanda

To search the database of designated NBs on NANDO’s website, click here.

Read our updates on EU MDR by clicking here.

Updates on the EUMDR

In response to the COVID-19 pandemic, EU regulators proposed a one-year delay on the new EU MDR, to May 2021.

The EU MDR Date of Application has officially been extended until May 2021. While most Regulatory Affairs and Quality Control professionals are rejoicing in this push-back, keep the ball rolling on meeting new MDR compliance. Those scrambling to review their products’ compliance may be able to exhale, but the race to completion is still on.

In 2017, EU came out with the new MDR, that would go into effect in 2020. Since then, medical device manufacturers have been tasked with determining which of their products need to be re-registered with participating Notified Bodies, in order to meet the new regulations for export in the EU. However, this posed a new problem for RA professionals.

The once lengthy list of Notified Bodies has now dwindled to only a handful. This poses a great problem for many manufacturers as Notified Bodies become more and more overwhelmed with products to register.

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Category Archives: Ask WCS!

Transformational Legislative Changes for European Pharma: What You Need to Know

Uncovering the Rich History of the Hague Convention

6 Tips for Apostille or Document Legalization

Notified Bodies Update

Updates on the EUMDR