Press Room

Over 60 of the largest companies in Ireland have publicly committed to set targets based on science by 2024. They are the first signatories of Business in the Community Ireland’s new Low Carbon Pledge. Business in the Community Ireland, the national network for sustainability, created the initial Low Carbon Pledge in 2018 with the aim of being a starting point for their member companies to commit to cutting their carbon footprint, report annually on their progress and develop a credible roadmap towards a net-zero economy. The new Low Carbon Pledge now calls on businesses to set science-based carbon emission reduction targets no later than 2024 (i.e. what science says is necessary to limit global warming to 1.5°C). The 61 signatories are: A&L Goodbody, Abbvie, ABP Foods, Accenture, Actavo, AIB, ALDI, Allianz, An Post, Arup, Aviva, Bank of Ireland, Bidvest Noonan, Boots, Britvic, BT Ireland, Cairn Homes, Cisco, Cook Medical, Dawn Meats, Deloitte, DePuy Synthes, Diageo, Dublin Bus, EirGrid, Enterprise-Rent-a-Car, ESB, Fujitsu, Gas Networks Ireland, Grant Thornton, HEINEKEN Ireland, Hovione Ireland, Irish Rail, Irish Distillers, Irish Water, Janssen, Johnson & Johnson Vision Care, KBC Bank, Keelings, KPMG, Lidl, M&S, Momentum Support, Mercury Engineering, Musgrave, Ornua, Permanent TSB, PM Group, PwC, RTÉ, Sky, Sodexo, SSE, Tesco, Three Ireland, Ulster Bank, Verizon, Veolia, Virgin Media Ireland, Vodafone and William Fry. The 61 signatory companies will commit to: Record their entire carbon footprint, both direct (Scope 1 & 2) and indirect (Scope 3) emissions Reduce emissions that they are directly responsible for (Scope 1 & 2), as well as play their part in reducing emissions across their Supply Chain (Scope 3) Report individually through an annual report or website or other publicly available equivalent source and collectively through an Annual Business in the Community Ireland Low Carbon Report As our understanding improves, signatory companies are asked to commit to regularly Reviewing their carbon reduction targets to align to the latest climate science. Minister for Communications, Climate Action & Environment, Eamon Ryan T.D. welcomed the announcement and commented, “As COP26 approaches, we must accelerate our climate response across our economy and society. I commend Business in the Community Ireland on this collective action especially as it brings together companies from different sectors and at different levels of maturity on their decarbonization journey. A low carbon economy is imperative for our post-pandemic recovery as it will support our long-term competitiveness, job creation and social cohesion.” The key strength of the Pledge lies in the collaborative platform which enables signatory companies to learn from each other’s successes and challenges. By working collectively, the Low Carbon Pledge movement builds capacity, fosters innovation and drives the ambition in delivering the changes needed. Tomás Sercovich, CEO, Business in the Community Ireland (BITCI), said, “With yesterday’s publication of the Climate Action Bill which commits Ireland to be a net-zero carbon State by 2050, the role of business in reaching this target is vital. Investors, regulators, consumers, suppliers and employees expect business to lead the net-zero vision we all aspire. Transparency and accountability are fundamental for the change to happen. The Low Carbon Pledge is a clear demonstration of businesses driving towards decarbonization, creating the business models, innovation and jobs for a low carbon future. As more businesses join this Pledge, we will use our collective voice to drive the new systems thinking we need to overcome this fundamental challenge.”    

Press Clipping

Ireland: Over 60 companies sign up to BITCI’s new Low Carbon Pledge

Mar 29, 2021

  Dear representatives of the Commission, Dear Ministers, Ladies and Gentlemen, Good-Morning It is a privilege for me to address you.   Dear Pedro thank you for giving me this opportunity.   I have been fortunate to have a front row seat watching the Pharmaceutical Industry since I was born, that was 60 years ago. Hovione was founded by my father, a Hungarian refugee, in the basement of our home in Lisbon. Often as children we could not go into the garden because a bromination was going on a l’air libre for safety reasons! My first job in the family business, aged 24, was selling active ingredients made in Portugal to Indian firms in Bombay, Madras, Delhi and Goa.   I will start by telling you about the successes of our industry and end with our failures as these are the ones we need to collectively tackle.   10 years after the HIV virus was discovered in Paris and Washington, American companies invented the protease inhibitors that would treat this horrible disease. But who made these complex molecules industrially possible then were exclusively European companies.   In the last decade several cures for Hepatitis C were discovered. Over 4 million patients have been cured and ¾ of those with pills made with a Hovione process with product that came out of our plants in Portugal and Ireland.   It is also important to acknowledge the complexity of the manufacturing processes and the extreme specialization that each step requires. Remdesivir, one of 3 approved therapies for Covid-19 needs factories in two continents just to make the active ingredient, but it won’t work without an enabling excipient called Captisol® that Hovione makes exclusively. To face the pandemic’s tremendous demand we are now making per month what we usually made per year.   Europe has 600+ plants that have the science, the technology, the know-how and the capacity to be the workhorse of innovative medicines for global supply. For most of us it has been some time that we have stopped focusing on serving the generics industry of our home market, Europe. Hovione has not supplied one kilo of a generic API to Germany for 15 years because one cent of difference means the Indian product is preferred. Had we not exported to the USA and served innovators and generics there we would be bankrupt, or weak and unable to invest in R&D and new technology.   The beauty of the pharma ecosystem is that the very high prices of patented products pay for the R&D and the risk, but as soon as the patents expire the best science can be had for a few cents per pill. Innovative drugs, under patent, and the large multinationals are today a minority volume player – over 80% of prescriptions are filled by generics.   Today the EU is not in control of its generic medicines – we face frequent shortages and a geostrategic fundamental dependence for APIs and precursors from India and China – where serious accidents, government policies and market failures make us vulnerable.    We have ended up in this untenable situation due to 1) the unbridled market forces of globalization and 2) 30 years of EU regulations that failed to consider that pharma is an intensely globalized and highly competitive industry.   Europe was once the cradle of pharmaceuticals. In the 50s any American that wanted to study chemistry had to learn to speak German as all good text books were written in German. We have faced a 30 year decline – today in the top 10 largest generic firms in the world only 1 is European.     As an industry we survived by moving away from intermediates and generic APIs – including the essential ones – and focusing on high value innovative products. The world is competitive and if the climate in Europe in unfavorable to certain segments, factories move – it is that simple.   Nobody saw the unfolding of this radical structural transformation. Nobody heard Industry’s calls for levelling the playing field.     In 2004 the EU API industry founded EFCG, the European Fine Chemicals Group, a member of CEFIC, to level the playing field, this need remains.    In my first trip to Brussels to flag the growing risk to patients and the lack of level playing field, in 2005, I was met with bemusement, étonnement and some sarcasm. In 2007 I testified at a hearing of a sub-committee of the US congress in connection with the risks to patient from imported APIs. I went public and frequently said and wrote that EU Regulators inspected on proximity not risk. The contaminated heparin tragedy that killed over 150 patients occurred in 2008. By 2011 our advocacy work resulted in the Falsified Medicines Directive, too little, too late.    Today price pressure has driven the European Generics supply chain to, in 74% of cases, buy from low-cost countries. These production locations have low regulatory oversight therefore present higher risk to patient, often cause environmental damage and antimicrobial resistance because of poor control over wastes, and have a high frequency of deadly accidents – the EU industry cannot compete with such low standard, low cost operations.    In summary in the last 30 years a large part of the EU API and intermediates industry disappeared to the benefit of its competitors. Certain key technologies (eg fermentation, nitration, halogenation) almost disappeared from Europe. This represents a damaging loss of critical mass, as these technologies act as platforms that allow the production of many different APIs.  Fermentation is key to making many antibiotics. Without fermentation Europe is now totally vulnerable and dependent on supplies from Asia/China.   To reduce this dependence and to ensure the resilience of the medicines supply chains on the long term, the only solution is to rely on the robust, reliable, competitive and sustainable manufacturing capabilities we still have in Europe.   So what are Industry’s proposals in this regard?   First, we must support the existing European manufacturers of APIs and intermediates in the on-shoring of technologies that will guarantee the supply of the essential medicines. Dual sourcing of the essential medicines must be a cornerstone of our policies.   Second, level the playing field with other world regions to ensure that import and purchase requires not only verified compliance with GMPs, but also demands process safety, respect for the environment and an absolutely reliable supply chain. Linking the purchase of critical supplies to the sole criteria of price cannot be a sustainable supply strategy.   Third, we need a long-term EU industrial policy that can accelerate sustainable Research, Development and industrialization of innovative and green technologies, as well as manufacturing capacities within the EU territory.   Fourth, regulatory centralization, transparency and flexibility. EMA must be given more clout. We need a central record of EU shortages.  EMA must know the complete supply chain mapping of each medicine, so it can act. EMA should turn into a compliance matter the good example of the Swedish regulator that considers environmental aspects when granting permits and approving products and APIs.   We are optimistic that this straightforward strategy will be successful to eliminate not only existing drug shortages but more importantly avoid future risks of shortages.     Europe can rely on its the 600+ existing manufacturing sites, on its strong innovation capacity, its highly-trained workforce to reverse the trend and build back a robust pharmaceutical industry in Europe.   Industry is involved in the Commission’s EU Pharma Strategy Structured Dialogue. We are looking forward to working with the Commission to implement, as quickly as possible, the appropriate structural, pragmatic and efficient measures to support our industry.    However as we embark to build the future and drive a Renaissance of the European API and generic industry it is imperative that we first look into the past and understand what got us into this situation of dependence and weakness.    The US and Japan have already launched countermeasures, we must work with our allies and not independently.   An EU patient centric pharmaceutical industry needs a EU centric pharma supply chain with a sustainable EU manufacturing base, this requires deliberate and careful regulation to compensate for market forces and to correct the playing field.   European citizens deserve medicines that are Affordable, Accessible and most importantly Available.    Dear Commission representatives, you can count on me and on our industry associations to fill in the blanks, spend time analyzing the situation and design a solution for the future.   Thank you for your attention.   Guy Villax CEO, Hovione Lisbon, 22nd March 2021 PDF version       Find more about this virtual event at 2021portugal.eu    

News

Guy Villax speech to the Informal Meeting of Ministers Responsible for Competitiveness

Mar 22, 2021

Cork, Ireland, 17 March 2021 – Hovione announced at the Ophthalmology Innovation Summit (OIS) Dry Eye Showcase the successful completion of its Phase 2 clinical trial in 270 patients with Dry Eye caused by Meibomian Gland Dysfunction (MGD). The well controlled and representative study was conducted across 26 clinical sites in the United States and tested 2 different strengths of minocycline against vehicle in a 1:1:1 randomization. This is the first dry eye therapy targeting MGD patients with ocular inflammation demonstrated by an MMP-9 based diagnostic and the first and only ophthalmic formulation of minocycline in clinical development, contingently named Meizuvo®. The study observed superior clinical outcome in the 70% of patients with positive inflammatory biomarker at baseline, who achieved statistically significant (p=0.02) improvement of 25 points in the Visual Analogue Scale (VAS) discomfort after 2 weeks of treatment, dropping further to 35 points by the end of treatment (an improvement greater than 50%). The sign endpoint inferior Cornea Fluorescein Staining, which is a measure of corneal damage in dry eye, had a statistically significant improvement against vehicle in both active arms at day 57 (p=0.009). The product was safe and well tolerated with less than 3% of subjects reporting blurring vision or eye irritation. Carla Vozone, Vice President of the innovative proprietary portfolio at Hovione commented: “The correlation between the patients with a positive MMP-9 assay at baseline and the clinical improvement observed in both signs and symptoms of dry-eye was groundbreaking”. Ms. Vozone explained that investigational Meizuvo® not only has the potential of adding a much needed treatment specific for assay recognized inflammation, but could also reduce the risk of failure in the pivotal studies by inclusion of the patient sub-set most responsive to the drug. OIS panelists, who shared their Clinical Perspectives, consensually identified chronic inflammation as the underlying cause of Dry Eye Disease highlighting the relevance of diagnostics to recognize such inflammation. George Magrath, M.D., CEO of Lexitas Pharma Services stated “We were thrilled with the opportunity to work on this exciting project.  Minocycline is a well-known molecule for ophthalmologists and there is significant excitement from the ophthalmology community regarding the potential for a topical alternative. The results in the overall population were encouraging in both signs and symptoms.  The results in the inflamed group of subjects were impressive with consistent statistically significant results in key dry eye signs and symptoms.”   About Minocycline Ophthalmic Meizuvo® (contingent brand name), is the first minocycline repurposed for ophthalmic administration, targeting a novel indication for inflamed MGD. It is a preservative-free formulation enabled by Hovione’s proprietary minocycline base which is stabilized as a microparticle in a novel vehicle. The highly tolerable formulation maximizes bioavailability, efficacy and reduces systemic effects. Tetracyclines have been known to treat MGD through anti-inflammatory activity and inhibition of matrix metalloproteinases (MMPs). Minocycline is of particular interest due to its lipophilic nature and resultant affinity to the meibomian gland. Previous research also suggests lipase inhibition effect, which decreases meibomian gland lipid degradation and consequently avoids the release of fatty acids, a synergistic mechanism of downregulating the inflammatory process. As such, minocycline has the potential to address several of the mechanisms that lead to the chronic nature of MGD.   About Inflamed Meibomian Gland Dysfunction MGD is a highly prevalent, chronic condition in the eyelid glands which alters the lipid composition of the tears and triggers evaporation-induced tear hyperosmolarity. Evaporative Dry Eye, which affects 27 million people in the USA, constitutes approximately 80% of all Dry Eye Disease and is largely caused by MGD. The pathophysiological changes of the meibomian gland and tear film instability trigger an inflammatory cascade which results in increased matrix metalloproteinase (MMP-9). Left untreated, the MMP-9 activity in the tear will disrupt the corneal epithelial barrier and induce damage of the ocular surface causing ocular irritation and visual morbidity in dry eye patients. Hovione’s presentation made by Courtney Smith, Director of Business Development & Licensing is accessible here     About Hovione Hovione is an international company with over 60 years of experience as a Contract Development and Manufacturing Organization (CDMO) and is currently a fully integrated supplier offering services for drug substance, drug product intermediate and drug product. With four FDA inspected sites in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers, the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.    

Press Release

Hovione completes its Phase 2 clinical trial of the first minocycline ophthalmic

Mar 17, 2021

This year’s theme for International Women’s Day is #ChooseToChallenge to celebrate the achievements of women around the world. Today Hovione women also #ChooseToChallenge. From Portugal to the USA, Ireland, Macau and India, we celebrate our team’s achievements. Thank you to Beatriz Noriega Fernandes, Camie Lou, Kristen Parisi, Linda Cullinane, Louise Dennehy, Madhu Gautam, Mafalda Paiva, Marianna Katz, Marilena Ornelas, Mary Hennessy, Sarah Downing, Sarah Scott, Sónia Cardoso and Tânia Dias for raising their hands high.  From challenge comes change. Read their statements here.   O tema deste ano do Dia Internacional da Mulher é #ChooseToChallenge - Escolher Desafiar - para celebrar as conquistas das mulheres em todo o mundo. As mulheres Hovione também aderiram à campanha #ChooseToChallenge. De Portugal aos EUA, Irlanda, Macau e Índia, celebramos as conquistas da nossa equipa.   Obrigada Beatriz Noriega Fernandes, Camie Lou, Kristen Parisi, Linda Cullinane, Louise Dennehy, Madhu Gautam, Mafalda Paiva, Marianna Katz, Marilena Ornelas, Mary Hennessy, Sarah Downing, Sarah Scott, Sónia Cardoso e Tânia Dias por levantarem as vossas mãos. Do desafio vem a mudança. Leia os seus testemunhos aqui.     My name is Kristen and I’m a HR Business Partner at Hovione USA. My journey at Hovione has been one of my proudest professional achievements. I started June of 2017 in the capacity of a split role, supporting HR initiatives while maintaining office management. I have since been promoted twice and currently hold the role of HR Business Partner. Hovione provides the necessary tools and opportunities for TM’s to have a fulfilling and challenging career. O meu nome é Kristen e sou HR Business Partner na Hovione EUA. O meu trajeto na Hovione é uma das conquistas profissionais de que mais me orgulho. Comecei em junho de 2017 a apoiar iniciativas de RH enquanto mantinha a gestão do escritório. Desde então, fui promovida duas vezes e atualmente exerço a função de HR Business Partner. A Hovione fornece as ferramentas e oportunidades necessárias para que as Colaboradoras tenham uma carreira gratificante e desafiadora. Kristen Parisi - HR Business Partner Hovione USA     My name is Madhu and I’m a Director at Hovione India office. I believe in a world where everyone – regardless of their age, gender, religion, disability, sexual orientation, or ethnicity - is provided with equal opportunities and I share this belief with Hovione. To all my colleagues around the world I raise my hand: by working at Hovione we have committed ourselves to save lives and improve the quality of life of millions of patients. There is no limit to what we can do together. Be proud. Be happy! O meu nome é Madhu e sou diretora do escritório da Hovione Índia. Acredito num mundo onde todos - independentemente da sua idade, sexo, religião, incapacidade, orientação sexual ou etnia - tenham oportunidades iguais e partilho esta convicção com a Hovione. A todas as minhas colegas em todo o mundo, levanto a minha mão: ao trabalhar na Hovione, comprometemo-nos a salvar vidas e a melhorar a qualidade de vida de milhões de pacientes. Não há limite para o que podemos fazer em conjunto. Tenham orgulho. Sejam felizes! Madhu Gautam - Director of Hovione India Hovione India     My name is Camie Lou and I’m the Administrative Manager at Hovione Macau. I am proud to be part of a workplace where everyone is welcomed and so many women have the opportunity to achieve their full potential. I am challenged every day to perform my best and to all my colleagues around the world, I raise my hand: celebrate daily your personal and professional achievements. Let’s celebrate this day together! O meu nome é Camie e sou Administrative Manager na Hovione Macau. Tenho orgulho de fazer parte de uma empresa onde todos são bem-vindos e onde muitas mulheres têm a oportunidade de atingir todo o seu potencial. Sou desafiada todos os dias a dar o meu melhor e para todas as minhas colegas em qualquer parte do mundo levanto a mão: comemorem diariamente as vossas conquistas pessoais e profissionais. Vamos comemorar este dia juntas! Camie Lou - Administrative Manager Hovione Macau     At Hovione Eireann, we are very proud of our diverse and inclusive culture and love to find ways to celebrate it. One aspect of our diversity is our gender balance across our teams and at all levels of the organization and therefore we have again decided to plan an event to celebrate the annual ‘International Women's Day’ on Monday March 8th. We will host a virtual art class, during which we will design a card to send to a woman who inspires us. In keeping with this year’s theme, #choosetochallenge, we are challenging ourselves to try something new and creative, keeping in mind the importance of ensuring everyone on our teams has a voice. This year our event is in aid of Cuanlee, a women's refuge in Cork city which has seen a big increase in calls for help this year due to the lockdowns over the past 12 months. We hope our contribution towards them helps in some way with the challenges they face every day. Na Hovione Irlanda, temos muito orgulho da nossa cultura diversificada e inclusiva e adoramos encontrar formas de a celebrar. Um aspeto da nossa diversidade é o equilíbrio de género nas nossas equipas e em todos os níveis da organização e, por isso, decidimos novamente planear um evento para celebrar o ‘Dia Internacional da Mulher’ na segunda-feira, 8 de março. Faremos uma aula de arte virtual, durante a qual desenharemos um cartão para enviar a uma mulher que nos inspire. De acordo com o tema deste ano, #choosetochallenge, estamos a desafiar-nos para tentar algo novo e criativo, tendo em mente a importância de garantir que todos nas nossas equipas têm uma voz. Este ano, o nosso evento irá apoiar a Cuanlee, um refúgio feminino na cidade de Cork, que teve um grande aumento no número de pedidos de ajuda devido aos confinamentos dos últimos 12 meses. Esperamos que a nossa contribuição as possa ajudar a enfrentar os desafios de todos os dias. Mary Hennessy - Director of Human Resources Ireland Louise Dennehy - HR Business Partner, Linda Cullinane - Supply Chain Director, Sarah Downing - QA Director, Sarah Scott - Product Quality Manager Hovione Ireland     My name is Tânia and I’m an Events Coordinator at Hovione Portugal. In my professional career, I have always achieved my goals, always keeping an attitude based of humility, integrity, and an open mind! Joining Hovione was one of those goals, and it has brought me new experiences, both professionally and personally. O meu nome é Tânia e sou Events Coordinator na Hovione Portugal. No meu percurso profissional, tenho lutado sempre para concretizar as metas a que me proponho, seguindo sempre a minha visão pessoal de humildade, integridade e otimismo! A entrada na Hovione foi uma dessas metas, que me tem trazido novas experiências quer a nível profissional como pessoal. Tânia Dias - Events Coordinator Hovione Portugal     My name is Mafalda and I am a proud scientist at Hovione R&D Portugal. My journey here began six years ago, as an analytical chemist, and evolved to management positions, all within R&D. I am passionate about science, business and people! I truly believe that we can all achieve our goals and pursue our passions, if we truly work for it, independent of gender, race, sexual orientation or religion. The sky is, indeed, the limit! O meu nome é Mafalda e sou uma orgulhosa cientista na Hovione Portugal. A minha viagem começou aqui há seis anos, como analytical chemist, e evoluiu para cargos de gestão, tudo dentro da área de R&D. Sou apaixonada pela ciência, negócios e pessoas! Acredito verdadeiramente que todos podemos alcançar os nossos objetivos e seguir as nossas paixões, se realmente trabalharmos para isso, independentemente do género, raça, orientação sexual ou religião. O céu é, de facto, o limite! Mafalda Paiva - Group Leader, R&D Analytical Development Hovione Portugal     My name is Marilena and I’m an Operational Excellence Engineer at Hovione Portugal. I always thought that to practice cross fit you had to be very strong and a bit crazy. Guess what, I am one of the crazy ones, and all I needed was to step out of my comfort zone, to practice a lot and never give up. O meu nome é Marilena e sou Operational Excellence Engineer na Hovione Portugal. Sempre achei que para praticar cross fit era necessário ser uma pessoa muito forte e louca. Adivinhem, eu sou uma das loucas, e tudo o que eu precisava era sair da minha zona de conforto, praticar muito e nunca desistir. Marilena Ornelas - Operational Excellence Engineer Hovione Portugal     My name is Beatriz and I’m a scientist at Hovione Portugal. From a small town to the capital, from engineering to pharmaceutical development, I feel a sense of accomplishment knowing my everyday small tasks help to save lives. I was lucky to be born in a place where I had all the opportunities available for me, however this is still not the case for so many women all around the world. I will continue to speak up for them.  O meu nome é Beatriz e sou cientista na Hovione Portugal. De uma pequena cidade à capital, da engenharia ao desenvolvimento farmacêutico, sinto-me realizada por saber que as minhas pequenas tarefas diárias ajudam a salvar vidas. Tive a sorte de nascer com todas as oportunidades à minha espera, mas esse ainda não é o caso de muitas mulheres em todo o mundo. Por elas, continuarei a falar. Beatriz Noriega Fernandes - Scientist, R&D DPD Inhalation Hovione Portugal     My name is Sónia and I work at RDP Analytical Sciences at Hovione Portugal. I feel glad to be able to enjoy a fulfilled life by combining the things that I love most: family, science and helping others. O meu nome é Sónia e trabalho na área de RDP Analytical Sciences na Hovione Portugal. Estou feliz por ter uma vida plena ao combinar as coisas que mais amo: família, ciência e ajudar os outros. Sónia Cardoso - RDP Analytical Sciences Hovione Portugal     My name is Marianna and I'm a Scientist at Hovione Portugal. Study hard. Play the cello. Move abroad. Run a half marathon. Explore different cultures. Work hard. Do a headstand. Innovate. Have fun. Change lives. Love. Choose to challenge. The sky is the limit. Women are versatile, support and acknowledge them! O meu nome é Marianna e sou cientista na Hovione Portugal. Estuda muito. Toca violoncelo. Muda de país. Corre uma meia maratona. Explora diferentes culturas. Trabalha no duro. Pratica headstand. Inova. Diverte-te. Muda vidas. Ama. Escolhe desafiar. O céu é o limite. As mulheres são versáteis, vamos apoiá-las e reconhecê-las! Marianna Katz - Scientist – R&D Products Hovione Portugal              

News

2021 International Women's Day - Read statements

Mar 08, 2021

Guy Villax spoke for the EU API industry at the EU Pharma Strategy Structured Dialogue that the EU Commission launched today. He said: EFCG members make Active Pharmaceutical Ingredients, the core of medicines. The EU has not been in control over its generic medicines for some time – we face frequent shortages and a geostrategic fundamental dependence on APIs and precursors from India and China – where serious accidents, government policies and market failures make us vulnerable.   We have ended up in this untenable situation due to i) unbridled market forces and globalization and ii) 30 years of EU regulations that did not consider that pharma is an intensely globalized and highly competitive industry.  Europe was once the cradle of pharmaceuticals. Today price pressure has driven the generics supply chain to prefer to buy 74% of APIs and precursors from low cost countries with limited regulation. These production locations have low regulatory oversight therefore present higher risk to patient, often cause environmental and antimicrobial resistance because of poor control over wastes, and have a high frequency of deadly accidents – EU industry cannot compete with such low cost operations.   EFCG was founded to level the playing field, this need remains. An EU patient centric pharmaceutical industry needs a EU centric pharma supply chain with a sustainable EU manufacturing base, this requires deliberate and careful regulation to compensate for market forces and to correct the playing field. The US and Japan have already launched countermeasures, we must work with our allies and not independently. European citizens deserve medicines that are Affordable, Accessible and most importantly Available. EFCG knows the issues well and is ready to help, count on us in this partnership. Pierre Luzeau will next list the needed solutions.     The meeting gathered representatives of pharma industry (generics and innovators), patients, hospital pharmacists as well as addressed Minister Marta Temido, MEPs Dolors Montserrat and Nathalie Colin–Oesterlé, Commissaires Kyriakides and Breton, Vice President Schinas.    About the Structured dialogue on Security of Medicines Supply   About EFCG    

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Guy Villax spoke for the EU API industry

Feb 26, 2021

    好利安藥廠火警疏散演習 Fire and evacuation simulator at the pharmaceutical factory “Hovione”   Firefighters fought the fire by the storage tank. The Fire Brigade (CB) held on the morning of February 24th this year, a fire and evacuation simulator with dangerous chemical substances in the pharmaceutical factory “Hovione” together with Hovione FarmaCiencia SA, with the intention of intensifying the measures contingency and the coordination and communication mechanism between both parties in case of incidents. The exercise simulated that a worker discovered that the leak occurred at the connection point of the methanol solution storage tank, thus causing a fire. The employee immediately sounded the fire alarm, the pharmaceutical factory's emergency and contingency team immediately proceeded to the internal contingency action, called the CB to ask for assistance and adopted security measures to evacuate the employees to the evacuation and meeting place. During the evacuation period, there was 1 worker who was injured. After becoming aware of the occurrence of a fire at the pharmaceutical factory “Hovione”, the CB immediately dispatched 9 emergency vehicles and 38 firefighters to the site to fight the fire, carry out the evacuation and search according to the defined plan, as well as provide nursing care for the injured and simulate transport to the hospital. The simulation lasted almost 1 hour. CB and the pharmaceutical factory “Hovione” sent around 160 people to participate in the simulation, whose main purpose is to test the responsiveness and the communication mechanism between the relevant parties in case of incidents. The respective process went well, after the simulation, both parties held a review meeting, whose objectives and expected results were achieved. [Translated from the original]       好利安藥廠火警疏散演習 為加強與好利安藥廠在發生事故時的應變措施及協調溝通機制,消防局於本年2月24日上午,與好利安製藥科學股份有限公司在氹仔好利安藥廠聯合舉行化學危險品火警及疏散演習。 演習模擬工作人員發現一個含有甲醇溶液的儲存缸接駁口出現洩漏並發生火警,工作人員隨即按動火警警報,藥廠緊急應變隊伍即時啟動內部應變計劃,同時致電消防局求助,以及採取安全措施疏散員工到逃生集合點,於疏散期間有一名員工不慎受傷。消防局接報好利安藥廠發生火警後,立即派遣9架緊急車輛及38名隊員趕赴現場,按照既定計劃進行滅火及疏散搜救行動,並對傷者進行即時護理及模擬送院,演習過程歷時約1小時。 消防局和好利安藥廠合共派出近160名人員參與是次演習,主要目的是測試發生事故時雙方的應變能力及溝通機制,演習過程順利,事後雙方進行檢討會議,並達到預期目的及效果。     Simulacro de incêndio e evacuação na fábrica farmacêutica “Hovione” Os bombeiros combateram o fogo junto do tanque de armazenamento. O Corpo de Bombeiros (CB) realizou na manhã do dia 24 de Fevereiro do corrente ano, um simulacro de incêndio e evacuação com substâncias químicas perigosas na fábrica farmacêutica “Hovione” em conjunto com a Hovione FarmaCiencia SA, com o intuito de intensificar as medidas de contingência e o mecanismo de coordenação e comunicação entre ambas as partes em caso de incidentes. O exercício simulou que havia trabalhador que descobriu que ocorreu a fuga no ponto de ligação do tanque de armazenamento da solução de metanol, acontecendo assim um incêndio. O empregado tocou imediatamente o alarme de incêndio, a equipa de emergência e contingência da fábrica farmacêutica procedeu logo à acção de contingência interna, ligou ao CB para pedir auxílio e adoptou as medidas de segurança para evacuar os funcionários para o local de evacuação e encontro. Durante o período de evacuação, havia 1 trabalhador que ficou ferido. Depois de ter tido conhecimento da ocorrência de incêndio na fábrica farmacêutica “Hovione”, o CB enviou de imediato 9 veículos de emergência e 38 bombeiros ao local para combater o fogo, executar a acção de evacuação e busca conforme o plano definido, bem como prestar os cuidados de enfermagem junto do ferido e simular o transporte para o hospital. O simulacro durou quase 1 hora. O CB e a fábrica farmacêutica “Hovione” enviaram cerca de 160 pessoas para participar no simulacro, cuja finalidade principal é testar a capacidade de resposta e o mecanismo de comunicação entre as partes pertinentes em caso de incidentes. O respectivo processo correu bem, depois do simulacro, ambas as partes procederam a uma reunião de revisão, cujos objectivos e resultados esperados foram alcançados.   Read the article at News.Gov.MO        

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Fire and evacuation drill at the pharmaceutical plant “Hovione”

Feb 25, 2021

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