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

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.

Pakistan accedes to the Apostille Convention

Fifty-two years after the Apostille Treaty was created at the Hague Convention, growth in new signatories continues: On March 9th, 2023, Pakistan will become the newest participant.

As of this date, the Pakistani Embassy will no longer accept documents for the legalization process, but rather engage in the streamlined Apostille process, as established by the treaty.

At WCS, we have already prepared for a smooth transition. WCS will provide you with an apostille for Pakistan. From there, your document will be completed and ready for use in Pakistan—no additional steps are required.

Processing time at the U.S. Department of State is currently 11 weeks. All new document authentications, therefore, will be processed as apostilles starting March 9, 2023.

Pakistan will abolish the traditional requirement for legalization, which is often a lengthy and costly legalization process, with the issuance of a single Apostille certificate. This simplified framework facilitates the international circulation of public documents for individuals, families, and regulatory operators.

The HCCH 1961 Apostille convention has over 120 contracting parties and has become one of the most widely applied multilateral treaties in legal cooperation, with several million Apostilles issued each year.

Pakistan now joins recent new participants to the Hague treaty, such as Indonesia and Saudi Arabia. As always, you can count on WCS to manage the transition.

Westex CEO

WCS – Westex Group Gains Advisory Board Seat at the Global Chamber

WCS and its sister company, Westex Group, were delighted to host the Global Chamber’s Autumn event in support of global trade. During the event, Varghese George, founder and CEO was welcomed and introduced as the newest member of the Advisory Board by the Chamber’s Mi Jeong Hibbitts.

Varghese George recounted how his company began in a one-room office on Washington’s storied K Street corridor. He professed optimism for the future of global trade and breakthroughs in the supply-chain system. On K Street, situated among Washington’s influential power-brokers, he built a dynamic enterprise in the mid-1980s, exporting American goods to international infrastructure projects.

Shortly after, he saw a new business opportunity and founded WCS (Washington Consular Services) to meet the documentation requirements of the same businesses sending goods abroad. As developments have progressed, WCS is now a pioneer in document legalization and apostille services for the pharmaceutical and medical device sectors. Many of the most well-known global brands in various areas are represented on the company’s esteemed client list.

WCS, or Washington Consular Services, handles direct, comprehensive, and trustworthy document authentication services for international corporations. Westex Group is a renowned supply-chain management service specializing in locating materials, managing procurement, and facilitating export while adhering to budgets and deadlines. Please reach out to our associates at:

WCS: Info@wcss.com

Westex: Sales@westexgroup.com

Maryland State Capital Building.

WCS OCTOBER UPDATE

The State of Maryland has moved to Stage Three of the Maryland Strong: Roadmap to Recovery. Stage Three updates safety protocols and expands reopening plans. However, Washington DC and other neighboring states are still in Phase 2 of their respective COVID-19 recovery plans.

We continue to experience delays in authentication from the US Department of State. We are hopeful of an improvement in the coming months, as we have enlisted the assistance of our congressional delegations and industry associations to encourage more efficiency in document processing to reduce turnaround times for documents. State authorities and Embassies in Washington, DC have adapted to the crisis and turnaround times are predictable and improving.

We are also pleased to inform you that the Embassies of Vietnam and Egypt are now accepting documents directly (without processing through the U.S. Department of State) and this has greatly improved processing for these countries.

Our staff is practicing social distancing while working to meet our client needs. Additionally, we are taking all preventative measures to sanitize and safeguard the workspace as guided by our state.

WCS has recently launched a new website to bring in an exclusive user experience. WCS Express™ application provides the best option for legalization of your documents. The Submit a Request form is now replaced by the Order Now button, which will take you directly to WCS Express™. If you’ve never created an account–don’t worry, it’s simple and free to register! Please, contact us if you need more information. The WCS team is at your service, should you require any additional assistance,

Thank you for your continued support, stay safe and we hope you will enjoy using WCS Express™!

WCS Website: A New Look!

WCS has launched a new website recently to bring in an exclusive user experience. WCS Express™ application provides the best option for legalization of your documents. It provides very clear instructions and makes the process of order management seamless and transparent. We have created this application to give you the convenience of placing orders, checking status, making payments and tracking document submissions and more.

Watch a short video we made recently to introduce WCS Express.

The Submit a Request form is now replaced by the Order Now button, which will take you directly to WCS Express.

It is completely free to use, and very easy to create an account & navigate our services. Click here to log-on to WCS Express™ today!

If you are an existing customer; you should already have the login information to WCS Express. Place your orders in WCS Express and send the original document via mail or request us to process the attachment in WCS Express. Please, reach out to the WCS team at info@wcss.com should you require any additional assistance or have any suggestions.

Thank you for your continued support, we hope you will enjoy using WCS Express!

-WCS TEAM 

 

Submit a Request is now WCS Express -Get Started with your order now!