Speculation has abounded in recent weeks regarding the short and long term consequences of Brexit. For the pharmaceutical industry, there are ramifications both in the UK and across continental Europe.
Impact of Brexit, Swixit, Turkxit for the European Medical Device MarketGreenlight Guru
Brexit, Swixit, and Turkxit will impact the medical device market in Europe in the following ways:
1) After January 1, 2021, UK manufacturers will need to use a new UKCA marking and will lose recognition of their CE marks unless they take action. Northern Ireland will still recognize CE marks.
2) Switzerland's vote to end free movement could impact its mutual recognition agreement with the EU, requiring Swiss and EU manufacturers to take new steps for market access depending on if a new agreement is reached.
3) Unless Turkey's customs agreement is updated, Turkish manufacturers may lose access to the EU market after May 26, 2021 as the EU MDR and IVDR are not currently
As the UK Government prepares to publish the 'Repeal Bill' to give legal effect to the UK's withdrawal from the European Union, this paper looks at the possible implications for pharmaceuticals regulation. The paper by Andrew Hollingsworth gives a short overview of the current EU regulatory framework and looks at some of the options and potential outcomes in the forthcoming UK-EU negotiations.
A No-Deal Brexit and the Impact on Medical DevicesEMMAIntl
High risk medical devices are certified by an independent conformity assessment conducted by notified bodies (NB). The notified bodies are overseen by the national authority of each member state in the EU, and by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. NBs are also subjected to European commission audits...
VIETNAM – THE EU-VIETNAM FREE TRADE AGREEMENT TAKING EFFECT FROM 1 AUGUST 2020Dr. Oliver Massmann
The EU-Vietnam Free Trade Agreement (EVFTA) will take effect on August 1, 2020. According to analyses by the Vietnamese and World Bank, the EVFTA is expected to increase Vietnam's GDP growth by 2.18-3.25% by 2023, 4.57-5.3% by 2028, and 7.07-7.72% by 2033. It will also lift around 800,000 people out of poverty by 2030. The EVFTA eliminates over 90% of import tariffs between the EU and Vietnam within 10 years, providing significant opportunities for businesses and consumers in both markets. The agreement establishes fair competition rules and opens key sectors in Vietnam like services, procurement
Bashar H. Malkawi, UAE export controls: commitment commendable – but there’s ...Bashar H. Malkawi
1. The document discusses various export control and compliance issues related to the coronavirus pandemic. It provides several news briefs on changes to export controls and licensing procedures by various countries and regulatory bodies as they work to address medical supply shortages and security concerns arising from the pandemic.
2. The UK export control body says it has measures in place to continue processing export licenses during the crisis, though on-site audits will be replaced with remote audits. India bans exports of ventilators and masks.
3. A health technology company calls on governments to drop export restrictions on critical medical materials to expedite the global pandemic response.
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
Impact of Brexit, Swixit, Turkxit for the European Medical Device MarketGreenlight Guru
Brexit, Swixit, and Turkxit will impact the medical device market in Europe in the following ways:
1) After January 1, 2021, UK manufacturers will need to use a new UKCA marking and will lose recognition of their CE marks unless they take action. Northern Ireland will still recognize CE marks.
2) Switzerland's vote to end free movement could impact its mutual recognition agreement with the EU, requiring Swiss and EU manufacturers to take new steps for market access depending on if a new agreement is reached.
3) Unless Turkey's customs agreement is updated, Turkish manufacturers may lose access to the EU market after May 26, 2021 as the EU MDR and IVDR are not currently
As the UK Government prepares to publish the 'Repeal Bill' to give legal effect to the UK's withdrawal from the European Union, this paper looks at the possible implications for pharmaceuticals regulation. The paper by Andrew Hollingsworth gives a short overview of the current EU regulatory framework and looks at some of the options and potential outcomes in the forthcoming UK-EU negotiations.
A No-Deal Brexit and the Impact on Medical DevicesEMMAIntl
High risk medical devices are certified by an independent conformity assessment conducted by notified bodies (NB). The notified bodies are overseen by the national authority of each member state in the EU, and by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. NBs are also subjected to European commission audits...
VIETNAM – THE EU-VIETNAM FREE TRADE AGREEMENT TAKING EFFECT FROM 1 AUGUST 2020Dr. Oliver Massmann
The EU-Vietnam Free Trade Agreement (EVFTA) will take effect on August 1, 2020. According to analyses by the Vietnamese and World Bank, the EVFTA is expected to increase Vietnam's GDP growth by 2.18-3.25% by 2023, 4.57-5.3% by 2028, and 7.07-7.72% by 2033. It will also lift around 800,000 people out of poverty by 2030. The EVFTA eliminates over 90% of import tariffs between the EU and Vietnam within 10 years, providing significant opportunities for businesses and consumers in both markets. The agreement establishes fair competition rules and opens key sectors in Vietnam like services, procurement
Bashar H. Malkawi, UAE export controls: commitment commendable – but there’s ...Bashar H. Malkawi
1. The document discusses various export control and compliance issues related to the coronavirus pandemic. It provides several news briefs on changes to export controls and licensing procedures by various countries and regulatory bodies as they work to address medical supply shortages and security concerns arising from the pandemic.
2. The UK export control body says it has measures in place to continue processing export licenses during the crisis, though on-site audits will be replaced with remote audits. India bans exports of ventilators and masks.
3. A health technology company calls on governments to drop export restrictions on critical medical materials to expedite the global pandemic response.
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
This presentation was delivered during the “go-home-meeting” hosted by Pharmakon on Sept 9th, 2020. We shared our insights and thoughts on the impact of Brexit on medicinal products – in the pre-and post-approval phase, from the EU and the UK perspective.
State aid: main developments
Authors:
Ms Alessandra Forzano (European Commission)
Dr Danilo Samà (European Commission)
Abstract:
The Competition Policy Newsletter contains information on EU competition policy and cases. Articles are written by staff of the Directorate-General for Competition of the European Commission.
Editor:
Competition Policy Newsletter
European Commission
Directorate-General for Competition (DG COMP)
Keywords:
competition policy, EU case-law, state aids
JEL classification:
K21; L44
Year:
2012
Pages:
19-25
Citation:
Forzano, Alessandra, Samà, Danilo (2012), State aid: main developments, Competition Policy Newsletter, Vol. 3, Directorate-General for Competition, European Commission, Brussels, Belgium, pp. 19-25.
The EU Clinical Trials Directives (2001/20/EC) establishes provisions for conducting clinical trials on medicinal products in EU member states, including requirements for ethics committee approval, informed consent of subjects, and reporting of adverse events. It aims to harmonize rules across countries while maintaining patient protections. A directive requires EU states to implement its goals in their own laws but allows flexibility in how to do so. This directive regulates many aspects of clinical research in Europe.
This document summarizes the potential impacts of intellectual property provisions in the proposed EU-Mercosur Free Trade Agreement on access to medicines in Argentina. It finds that provisions extending patent terms, implementing data exclusivity, or a combination of both could significantly increase government expenditures on medicines by the Ministry of Health. Under the total exclusivity scenario, expenditures could increase by 30.6% in 2050 compared to the current system, costing over $2.6 billion more. For just 6 drugs, the additional expenditure in 2016 would be around $73 million compared to $113 million spent on all HIV and hepatitis drugs that year under current law. The study shows that medicine prices would dramatically rise with the adoption of more restrictive intellectual property
Aegate Symposium Frankfurt June 2015 - Graham day 1_fmdAegate
This document discusses the Falsified Medicines Directive (FMD) in the European Union. It provides details on the following key points:
1. The FMD requires medicines at risk of falsification to have unique codes and tamper-evident packaging to enable verification of authenticity.
2. Implementation requirements are being determined through Delegated Acts, which will specify uniform rules across all EU member states.
3. The Delegated Acts are expected to be adopted in August 2015 and published by the end of 2015, giving member states three years to implement safety features and authentication systems.
In this presentation, Dario Ghoddousi, VP Product Management, Compliance Solutions at QuintilesIMS and Ned Mumtaz, Practice Leader Life Sciences at qordata provide an overview of the implementation of the EFPIA disclosure code, the discrepancies in reporting requirements of member countries and areas of challenges. The presentation will further provide a detailed overview of reported EFPIA physician spend numbers, consent rates and the initiatives being taken by companies to increase the rate of consent.
Summary of instructions for implementation of pharmacovigilance (PV) system in the UK according to the MHRA guidelines and instructions. For more information visit www.tepsivo.com
Brexit refers to the UK's withdrawal from the European Union following a 2016 referendum where British voters chose to leave the EU. Brexit will impact India's economy in several ways. It could close the window of opportunity that the UK provided for Indian companies to do business in Europe. India exports 17.66% of its total exports to Britain. Key sectors affected include automotive, IT, metals, oil, and pharmaceuticals. However, Brexit may open opportunities for India's education sector through more scholarships for Indian students and reduced travel costs to the UK. The full impact remains uncertain as Brexit has not been fully implemented.
This document discusses Brexit and its implications for pharmaceutical and medical device regulation. It summarizes the Brexit timeline and process so far. It notes concerns that the UK establishing its own regulatory framework distinct from the EU's could lead to a lengthy approval process for drugs and increased administrative burden. It advises companies in the industry to identify risks from Brexit like funding, competition policy, contracts, taxation, and supply chains. It also says companies should consider opportunities in both the UK and EU27 from issues like customs, tariffs, regulation, and access to markets after Brexit. It quotes sources noting costs to business from new market barriers or divergent rules between the UK and EU. The document concludes by advising industry to stay informed on Brexit developments
Smoke, Europol’s fight against the illicit tobacco tradeillegalehandel
This document discusses Europol's mission to support law enforcement agencies in the European Union (EU) in preventing and combating organized crime. It specifically focuses on Europol's role in combating the illicit tobacco trade. Europol collects and analyzes criminal intelligence to help EU member states investigate cases like tobacco smuggling and counterfeiting. The illicit tobacco trade costs governments billions in lost tax revenue each year and funds other criminal activities like terrorism. Europol works with EU members on projects targeting factories, criminal groups, and shipping routes involved in the unlawful tobacco trade.
Euro shorts 09.09.16 including Brexit update: Theresa May meeting with Donald...Cummings
Welcome to Euro Shorts, a short briefing on some of the week’s developments in the financial services industry in Europe.
If you would like to discuss any of the points we raise below, please contact me or one of our other lawyers.
The test report summarizes the results of screening a sample of PVC insulation tape for substances of very high concern (SVHC). SGS screened the sample for 169 substances on the Candidate List of SVHC and found it to pass, containing ≤ 0.1% (w/w) of any listed substances. The report provides details on the testing methods, materials tested, and context regarding SVHC regulations for articles and substances in the European Union.
A Mutual Recognition Agreement for Pharma GMP InspectionsEMMAIntl
The European Medicines Agency (EMA) and the United States FDA have fully implemented the Mutual Recognition Agreement beginning July 11, 2019. This agreement allows the European member states and the FDA to rely on each other’s GMP inspections of pharmaceutical manufacturers...
Triggering Article 50 on 29 March 2017 officially started the Brexit negotiations: UK about to officially leave the EU in March 2019. In the short-run little clarity expected for business and policy makers.
The document discusses several news stories related to EU regulations and directives being implemented in the UK legal system. It provides examples of an EU regulation harmonizing rules around herbal medicines and electronic communications. It also discusses how the UK brings EU laws into force through the European Communities Act of 1972, allowing them to be implemented by statutory instrument without passing separate legislation. Additionally, it covers a case where a former banker appealed and was granted a larger divorce settlement, and emergency legislation being rushed through Parliament to reverse a court ruling on police bail.
Britain held a referendum on EU membership in June 2016 after long-standing calls from Eurosceptic parties and Prime Minister Cameron's 2013 promise. The referendum resulted in a vote to leave the EU, with younger and more educated voters more likely to vote remain. For Britain to actually exit the EU, Article 50 of the Lisbon Treaty must be invoked, starting a two-year negotiation process, but Prime Minister Cameron has not done so yet despite pressure from EU leaders to begin the exit process without delay.
ICAWC 2015 - Puppy Smuggling in Europe - Paula Boyden & Brigita KymantaiteDogs Trust
Dogs Trust, with the help of Animal Rights Protection Lithuania, has undertaken two investigations looking at the illegal import of puppies across the EU.
Dogs Trust, with the help of Animal Rights Protection Lithuania, has undertaken two investigations looking at the illegal import of puppies across the EU. Despite conclusive evidence from the 1st investigation being presented to the EU and national government along with a series of urgent recommendations set out by Dogs Trust to help curb the trade, the puppy trafficking trade has continued unabated. In early 2015, Dogs Trust went back into Eastern Europe to highlight that the Pet Travel Scheme (PETS) is still being used as a cover by commercial breeders and dealers in Lithuania and Romania on a regular basis to illegally import puppies, often in horrendous conditions, and transporting them thousands of miles without their mothers.
Nicole, cuyo nombre real es Denisse Lillian Laval Soza, es una cantante chilena nacida en 1977 en Santiago. Comenzó su carrera musical en la década de 1980 participando en programas de televisión y concursos de canto. En 1994 lanzó su álbum "Esperando Nada" que se convirtió en un éxito comercial. Desde entonces ha lanzado varios álbumes más y participado en diversos programas de televisión como jurado y conductora. Actualmente sigue desarrollando su carrera como cantante
State aid: main developments
Authors:
Ms Alessandra Forzano (European Commission)
Dr Danilo Samà (European Commission)
Abstract:
The Competition Policy Newsletter contains information on EU competition policy and cases. Articles are written by staff of the Directorate-General for Competition of the European Commission.
Editor:
Competition Policy Newsletter
European Commission
Directorate-General for Competition (DG COMP)
Keywords:
competition policy, EU case-law, state aids
JEL classification:
K21; L44
Year:
2012
Pages:
19-25
Citation:
Forzano, Alessandra, Samà, Danilo (2012), State aid: main developments, Competition Policy Newsletter, Vol. 3, Directorate-General for Competition, European Commission, Brussels, Belgium, pp. 19-25.
The EU Clinical Trials Directives (2001/20/EC) establishes provisions for conducting clinical trials on medicinal products in EU member states, including requirements for ethics committee approval, informed consent of subjects, and reporting of adverse events. It aims to harmonize rules across countries while maintaining patient protections. A directive requires EU states to implement its goals in their own laws but allows flexibility in how to do so. This directive regulates many aspects of clinical research in Europe.
This document summarizes the potential impacts of intellectual property provisions in the proposed EU-Mercosur Free Trade Agreement on access to medicines in Argentina. It finds that provisions extending patent terms, implementing data exclusivity, or a combination of both could significantly increase government expenditures on medicines by the Ministry of Health. Under the total exclusivity scenario, expenditures could increase by 30.6% in 2050 compared to the current system, costing over $2.6 billion more. For just 6 drugs, the additional expenditure in 2016 would be around $73 million compared to $113 million spent on all HIV and hepatitis drugs that year under current law. The study shows that medicine prices would dramatically rise with the adoption of more restrictive intellectual property
Aegate Symposium Frankfurt June 2015 - Graham day 1_fmdAegate
This document discusses the Falsified Medicines Directive (FMD) in the European Union. It provides details on the following key points:
1. The FMD requires medicines at risk of falsification to have unique codes and tamper-evident packaging to enable verification of authenticity.
2. Implementation requirements are being determined through Delegated Acts, which will specify uniform rules across all EU member states.
3. The Delegated Acts are expected to be adopted in August 2015 and published by the end of 2015, giving member states three years to implement safety features and authentication systems.
In this presentation, Dario Ghoddousi, VP Product Management, Compliance Solutions at QuintilesIMS and Ned Mumtaz, Practice Leader Life Sciences at qordata provide an overview of the implementation of the EFPIA disclosure code, the discrepancies in reporting requirements of member countries and areas of challenges. The presentation will further provide a detailed overview of reported EFPIA physician spend numbers, consent rates and the initiatives being taken by companies to increase the rate of consent.
Summary of instructions for implementation of pharmacovigilance (PV) system in the UK according to the MHRA guidelines and instructions. For more information visit www.tepsivo.com
Brexit refers to the UK's withdrawal from the European Union following a 2016 referendum where British voters chose to leave the EU. Brexit will impact India's economy in several ways. It could close the window of opportunity that the UK provided for Indian companies to do business in Europe. India exports 17.66% of its total exports to Britain. Key sectors affected include automotive, IT, metals, oil, and pharmaceuticals. However, Brexit may open opportunities for India's education sector through more scholarships for Indian students and reduced travel costs to the UK. The full impact remains uncertain as Brexit has not been fully implemented.
This document discusses Brexit and its implications for pharmaceutical and medical device regulation. It summarizes the Brexit timeline and process so far. It notes concerns that the UK establishing its own regulatory framework distinct from the EU's could lead to a lengthy approval process for drugs and increased administrative burden. It advises companies in the industry to identify risks from Brexit like funding, competition policy, contracts, taxation, and supply chains. It also says companies should consider opportunities in both the UK and EU27 from issues like customs, tariffs, regulation, and access to markets after Brexit. It quotes sources noting costs to business from new market barriers or divergent rules between the UK and EU. The document concludes by advising industry to stay informed on Brexit developments
Smoke, Europol’s fight against the illicit tobacco tradeillegalehandel
This document discusses Europol's mission to support law enforcement agencies in the European Union (EU) in preventing and combating organized crime. It specifically focuses on Europol's role in combating the illicit tobacco trade. Europol collects and analyzes criminal intelligence to help EU member states investigate cases like tobacco smuggling and counterfeiting. The illicit tobacco trade costs governments billions in lost tax revenue each year and funds other criminal activities like terrorism. Europol works with EU members on projects targeting factories, criminal groups, and shipping routes involved in the unlawful tobacco trade.
Euro shorts 09.09.16 including Brexit update: Theresa May meeting with Donald...Cummings
Welcome to Euro Shorts, a short briefing on some of the week’s developments in the financial services industry in Europe.
If you would like to discuss any of the points we raise below, please contact me or one of our other lawyers.
The test report summarizes the results of screening a sample of PVC insulation tape for substances of very high concern (SVHC). SGS screened the sample for 169 substances on the Candidate List of SVHC and found it to pass, containing ≤ 0.1% (w/w) of any listed substances. The report provides details on the testing methods, materials tested, and context regarding SVHC regulations for articles and substances in the European Union.
A Mutual Recognition Agreement for Pharma GMP InspectionsEMMAIntl
The European Medicines Agency (EMA) and the United States FDA have fully implemented the Mutual Recognition Agreement beginning July 11, 2019. This agreement allows the European member states and the FDA to rely on each other’s GMP inspections of pharmaceutical manufacturers...
Triggering Article 50 on 29 March 2017 officially started the Brexit negotiations: UK about to officially leave the EU in March 2019. In the short-run little clarity expected for business and policy makers.
The document discusses several news stories related to EU regulations and directives being implemented in the UK legal system. It provides examples of an EU regulation harmonizing rules around herbal medicines and electronic communications. It also discusses how the UK brings EU laws into force through the European Communities Act of 1972, allowing them to be implemented by statutory instrument without passing separate legislation. Additionally, it covers a case where a former banker appealed and was granted a larger divorce settlement, and emergency legislation being rushed through Parliament to reverse a court ruling on police bail.
Britain held a referendum on EU membership in June 2016 after long-standing calls from Eurosceptic parties and Prime Minister Cameron's 2013 promise. The referendum resulted in a vote to leave the EU, with younger and more educated voters more likely to vote remain. For Britain to actually exit the EU, Article 50 of the Lisbon Treaty must be invoked, starting a two-year negotiation process, but Prime Minister Cameron has not done so yet despite pressure from EU leaders to begin the exit process without delay.
ICAWC 2015 - Puppy Smuggling in Europe - Paula Boyden & Brigita KymantaiteDogs Trust
Dogs Trust, with the help of Animal Rights Protection Lithuania, has undertaken two investigations looking at the illegal import of puppies across the EU.
Dogs Trust, with the help of Animal Rights Protection Lithuania, has undertaken two investigations looking at the illegal import of puppies across the EU. Despite conclusive evidence from the 1st investigation being presented to the EU and national government along with a series of urgent recommendations set out by Dogs Trust to help curb the trade, the puppy trafficking trade has continued unabated. In early 2015, Dogs Trust went back into Eastern Europe to highlight that the Pet Travel Scheme (PETS) is still being used as a cover by commercial breeders and dealers in Lithuania and Romania on a regular basis to illegally import puppies, often in horrendous conditions, and transporting them thousands of miles without their mothers.
Nicole, cuyo nombre real es Denisse Lillian Laval Soza, es una cantante chilena nacida en 1977 en Santiago. Comenzó su carrera musical en la década de 1980 participando en programas de televisión y concursos de canto. En 1994 lanzó su álbum "Esperando Nada" que se convirtió en un éxito comercial. Desde entonces ha lanzado varios álbumes más y participado en diversos programas de televisión como jurado y conductora. Actualmente sigue desarrollando su carrera como cantante
Fabian Andres Espitia Cruz and Julian Esteban Salazar Velasco are individuals mentioned in the document. The document lists two names but provides no other context or information about these individuals.
Este documento presenta una introducción a la estructura interna de la materia. Explica las primeras teorías atómicas de Demócrito y Dalton, y luego describe los modelos atómicos de Thomson, Rutherford, Bohr, entre otros. También cubre conceptos como el número atómico, iones, enlaces químicos, moléculas y macromoléculas. Finalmente, introduce la teoría cinético molecular de los gases y resume las leyes de los gases ideales de Boyle, Charles, Gay-Lussac y la ley combinada.
This document provides the results of a StrengthsFinder assessment for Alexander Flores. His top 5 themes are Woo, Ideation, Developer, Positivity, and Competition. For each theme, the document describes what the theme represents and provides personalized insights into how the theme shows up uniquely in Alexander based on his responses. The insights highlight talents, motivations, and tendencies related to each theme that make Alexander stand out.
This document describes a process for producing articles composed principally of aluminium nitride. The process involves intimately mixing aluminium nitride powder with a minor proportion of powdered metal, a non-aqueous binder, and a non-aqueous solvent. The mixture is molded and then heated in a nitriding atmosphere to form aluminium nitride crystals bonded together by metal nitrides. The proportion of metal powder is critical to fill voids and produce compact articles after firing.
Este documento analisa três tipos de cartazes: 1) Um cartaz educativo sobre respeito e não-violência, usando o vermelho e texto legível para transmitir a mensagem. 2) Um cartaz publicitário chocante para cerveja usando cores quentes e frases curtas para atrair a atenção. 3) Um graffiti em prédio em ruínas que serve como cartaz de ambiência e também promove uma galeria de arte e arte pública.
The Internet of Things represents a major departure in the World Wide Web's development.The (loT) has become a powerful force for business transformation, and its disruptive impact will be felt across all industries and all areas of society.
Este documento presenta la introducción de un curso de Química para el primer año de Bachillerato. Resume los objetivos y enfoque del curso, la metodología a seguir que incluye la experimentación científica, y los bloques curriculares y destrezas que se desarrollarán durante el curso.
Enterprise product management in business environmentvasishta bhargava
The document discusses key considerations for enterprise product marketing and management in business including competitors, sales metrics, ownership counts, repeat orders, market share, the marketing mix of product, price, promotion, and place. It also covers topics like product differentiation, features, customer expectations, variants, discounts, advertising, distribution channels, geographic markets, and customer loyalty metrics.
Este documento describe el procedimiento de DCR endoscópica para tratar la epífora causada por la obstrucción del conducto nasolagrimal. La DCR endoscópica tiene una alta tasa de éxito sin necesidad de una incisión externa y mantiene el mecanismo de bombeo lagrimal. El procedimiento involucra la exposición del saco lagrimal a través de la mucosa nasal, la marsupialización del saco con la cavidad nasal y el cuidado posoperatorio con antibióticos y lavados salinos para mantener
This document summarizes key points from Chapter 9 of the 13th edition of Van Horne and Wachowicz's Fundamentals of Financial Management textbook. It discusses motives for holding cash, methods for speeding up cash receipts and slowing down cash payouts, and the use of concentration banking, lockbox systems, and zero balance accounts to improve cash management. It also covers investment of excess cash balances in marketable securities and tools for electronic commerce like lockboxes, automated clearinghouse transfers, and Check 21 that facilitate cash collections and disbursements.
The document discusses the role of financial management. It explains that financial management concerns acquiring, financing, and managing assets to achieve an overall goal. It also discusses the goal of the firm being shareholder wealth maximization and the potential agency problems that can arise from the separation of ownership and management in corporations.
There are a few key elements to describing a photo or picture. First, use "there is/are" to identify what objects are in the picture. Second, use the present continuous tense to describe what actions people in the picture are doing. Finally, locations of objects and people can be specified using prepositions like "at the top," "in the middle," "on the left," etc. Descriptions may also note things that are unclear using modal verbs.
European union’s medical technology market by emanuel baisireEmanuel Baisire
The document discusses market entry strategies for medical equipment companies entering the European Union market. It analyzes exporting, strategic alliances, and joint ventures. A strategic alliance with a European firm is identified as the best option to gain market knowledge, establish distribution channels, share costs and risks, and comply with regulatory requirements. Manufacturing locally in Europe through the alliance would allow the company to benefit from lower capital costs and currency exchange rates.
Brexit: The customs impact on UK businessesAlex Baulf
Following the referendum vote on 23 June 2016, the UK has voted to leave the EU. Exactly when this will happen and how is not yet known. In the coming months, the UK will be expected to submit its withdrawal notice to the EU Council -under Article 50 of the Treaty on European Union (TEU) -to formally notify the EU of its withdrawal. The notification will trigger a two-year notice period and negotiations on the terms of a UK exit will begin. Until then, UK businesses should continue to comply with and trade under the existing Union Customs Code (UCC) that entered into force on 1 May 2016.
Assuming that 'Brexit' does eventually happen, businesses need to:
• assess the risks and opportunities that this poses for their supply chain
• where possible, put in place plans to manage these changes, to ensure their activities run smoothly and mitigate the potential impact, and
• take appropriate steps to prepare for the ‘unknown’.
Unless there is a dramatic 'U' turn, it seems clear that, at some point in the future, the UK will leave the EU. From a UK business perspective such a move will not only present many challenges, but will also provide opportunities.
The vote to leave will continue to create considerable uncertainty until the details of any agreement(s) are known. Businesses affected by Brexit will need to plan for that uncertainty and will need to understand the potential impacts. For this reason, a supply chain impact assessment is prudent and should help to provide some clarity in relation to a business’s exposure.
I.s. forrester, a. dawes, parallel trade in medicinesMichal
The document provides an introduction and overview of issues related to parallel trade in prescription medicines in the European Union. It makes three main points:
1) Parallel trade in prescription medicines is different than parallel trade in other goods because patients do not shop based on price and national governments set medicine prices, not the market. Parallel trade does not significantly lower costs for patients or governments.
2) Parallel trade reduces profits for pharmaceutical companies that fund research and development of new medicines. It may also delay access to new medicines in some countries.
3) Parallel trade risks increasing the entry of counterfeit medicines into legitimate supply chains, as counterfeits are commonly made outside the EU and enter through parallel trade routes.
The European Medicines Agency has announced on 6th July that the Agency will continue its operations as usual, in accordance with the timelines set by its rules and regulations.
This document discusses trends in the global food industry based on a survey of 105 executives. It finds that while some manufacturers face short-term challenges, many are innovating to drive long-term growth. A key trend is the impact of new technologies like e-commerce. It also examines issues around food regulation post-Brexit, noting both risks and opportunities for reducing red tape that imposes costs on businesses. Rising global population will increase demand for food production. Profitability pressures threaten growth for some due to factors like intense price competition from retailers.
EU Referendum: Brexit and the Implications for BrandsOgilvy Consulting
No political question has captivated businesses in the same way as the British referendum on European Union membership (aka Brexit).
In this deck, two Ogilvy politicos to dive into the referendum, implications of a potential #brexit, and to advise on communicating around the outcome.
Mathew Shearman, Senior Account Manager at Ogilvy Healthworld London and James Stewart, Associate Director at Ogilvy Public Relations London cover:
- Perspectives on the challenges facing clients
- Recommend Brexit priorities for businesses and Leaders
- Deep-dive on implications for the pharmaceutical industry
'The B of the Bang' - What the UK Government’s white paper on Brexit means fo...Graeme Cross
The document summarizes key points from a UK government white paper on Brexit and its implications for businesses. It discusses potential impacts on several issues including:
- Free movement of capital and access to the European Economic Area for financial services.
- Immigration controls and their effect on attracting/retaining talent, particularly for the healthcare sector.
- Negotiating a new trading relationship and customs agreement between the UK and EU.
- Restrictions on free movement and their implications for internationally mobile employees and healthcare access.
- Compliance with EU data protection laws and heightened cybersecurity risks post-Brexit.
- The UK's ability to negotiate independent trade deals globally and support available for exporters.
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This document provides information on the 13th Annual Conference on Parallel Trade happening February 5-6, 2019 in London. The conference will address topics such as the impact of parallel trade on patient safety and pharmaceutical companies, Brexit's impact on parallel trade, and challenges around implementing the Falsified Medicines Directive. Speakers will represent companies such as Allergan, Almirall, Edwards Life Sciences, and the European Alliance for Access to Safe Medicines. Participants can register online and save money by registering earlier. The conference is organized by SMi Pharma.
BDO's Manufacturing Prospects Report, in association with the Institution of Mechanical Engineers, analyses the sector's outlook post the referendum, focusing on the key risks and opportunities, strategic plans and highlights manufacturers' top requirements from the EU trade agreement and industrial strategy.
This document provides information about a conference on pharmaceutical parallel trade taking place on February 6-8, 2018 in London. The conference will discuss the latest challenges in pharmaceutical parallel trade through keynote speeches, panel discussions, and workshops. It will cover topics such as the impact of parallel trade on pharmaceutical companies, competition law and parallel trade, patient safety and access to medicines, and the commercial aspects of parallel distribution. The document also provides details on two half-day post-conference workshops on February 8th focusing on parallel trade management strategies and the EU legal issues related to parallel trade of pharmaceutical products.
Brexit and the QPPV Pipeline April 2017John Barber
This document discusses the potential impacts of Brexit on the 1,299 UK-based Qualified Persons for Pharmacovigilance (QPPVs). It is currently unclear what Brexit will mean for these QPPVs, as the UK government has provided little guidance on its plans for medicines regulation post-Brexit. Losing access to the European regulatory framework could significantly impact UK-based QPPVs' ability to perform their roles and responsibilities. The author argues that QPPVs and others should voice their concerns about the implications of Brexit on patient safety.
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Brexit’s implications on the pharmaceutical industry
1. www.simon-kucher.com
Brexit’s implications on the
pharmaceutical industry
Pricing, market access and trade
Marc Matar, Partner
Sinead O’Sullivan–Carty, Senior Consultant
August 2016
London Office
1 Plough Place
London, EC4A 1DE, UK
Tel. +44 207 832 6820
E-mail: marc.matar@simon-kucher.com
2. Speculation has abounded in recent weeks regarding the short and long term consequences of
Brexit. For the pharmaceutical industry, there are ramifications both in the UK and across
continental Europe.
Pricing volatility
Coping with short term currency fluctuations and long term IRP implications
The most immediate market consequence of the Brexit vote is currency fluctuation, resulting in
continued uncertainty impacting European prices.
For novel products launching in Europe: A lower UK price may affect reference basket prices
for those European markets using international reference pricing (IRP) as the driving price
setting mechanism.
For post-launch products: The risk of re-referencing and price cuts arise.
Long-term, European markets may exclude the UK from their reference baskets due to the market’s
exit from the union.
Historically, the UK has been an early-to-launch market due to free pricing typically creating a higher
anchor for IRP. However, the UK may no longer be an attractive or supportive option in the early launch
sequence if European markets exclude the UK price from their reference baskets. Pharmaceutical
companies now need to assess and adapt their European launch sequence strategies as well as
monitor and minimise EU pricing risks for established products.
Within the UK, pharmaceutical pricing rules are expected to remain unchanged until the expiry of the
PPRS and subsequent re-negotiation in 2018. It’s the long term prospects in this new and evolving
competitive environment that will put UK launch prices at risk. With the NHS already under cost
pressure, and significant additional pressure expected depending on the economic impact of Brexit,
NHS regulators may need to take a harder stance on new drug and device prices, using it as an
opportunity for cost containment.
Market access
A new regulatory era
The final post-Brexit trade deal will have immediate, primarily UK-centric repercussions, potentially
transforming the UK’s regulatory structure. Adopting the EFTA or WTO model routes will lead to the
UK having greater or complete control over the verdict and speed of product and device market
authorisation.
A move away from EMA-led market authorisation in the UK will mean the expansion of the MHRA. The
result of such an expansion is unknown especially how process timelines and outcomes could be
affected. How easy will it be to gain UK market authorisation and how long will this take?
A new era for the MHRA therefore represents a potential market access risk.
Pharmaceutical companies may in the future consider deprioritising UK launches due to the time
and cost commitment of an additional regulatory application. Manufacturers may therefore need to
redefine their UK launch strategies. As we have already heard from patient groups this further adds
concern around patient access and outcomes.
3. Trade negotiation
Competing in the face of uncertainty
The UK trade agreement negotiated with the EU will impact all industries. If the UK no longer has
access to the single market, the revision of trade duties, routes, and customs processes is required.
Moreover, the UK may set its own import tariffs during negotiations.
For the pharmaceutical industry in particular, this is likely to impact parallel trade – import and export
of pharmaceutical products between different countries. The imposition of tariffs will discourage and
thus limit or halt parallel trade in some cases. This may benefit pharmaceutical companies who will be
able to better manage their revenues per market. However, in the UK market, less parallel trade is
likely to mean less competition, which in turn could lead to greater pressure on NHS resources.
Any trade agreement will also have serious consequences for UK-based pharmaceutical or MedTech
companies. Imposed duties or tariffs will impact profitability and could reignite the debate around
strategic relocation of headquarters and production. Furthermore, whilst uncertainty remains, there are
further risks to UK business, as companies will have lower willingness to invest heavily in the interim.
In the long term, Pharma is a global industry which should be insulated from Brexit consequences
commercially. We can look to Switzerland as evidence that life outside the EU is compatible with a
thriving pharmaceuticals sector. What remains uncertain is whether EU governments will grant the UK
similar privileges.
4. Simon-Kucher & Partners
Simon-Kucher & Partners is a global consulting firm specialising in TopLine Power®, which
encompasses strategy, marketing, pricing, and sales. Our practice is built on evidence-based,
practical strategies for profit improvement via the top line. Simon-Kucher & Partners is regarded
as the world's leading pricing advisor and thought leader.
Contacts
Global presence
33 offices worldwide, 930 employees, €209m revenue in 2015
Americas
Atlanta, Boston, Mountain View, New York, San Francisco, Santiago de Chile, São Paulo,
Toronto
Europe/Middle East
Amsterdam, Barcelona, Bonn, Brussels, Cologne, Copenhagen, Dubai, Frankfurt, Geneva,
Hamburg, Istanbul, London, Luxembourg, Madrid, Milan, Munich, Paris, Vienna, Warsaw,
Zurich
Asia/Pacific
Beijing, Singapore, Sydney, Tokyo