The new strategy dubbed “Shaping Europe’s digital future” is the EUs plan to shape the EU market with digital transformation. This new strategy builds upon the previous Commissions achievements in delivering its digital single market objectives.
Data has been put as a prime focus with the Commission believing that data is the “lifeblood of economic development” and can/should be used to address challenges facing society and for driving economic growth.
The Commissions first step is to bring forward proposals for an ‘enabling legislative framework for the governance of common European data spaces’ later this year. This legislation will establish nine distinct ‘common European data spaces’ in areas such as manufacturing, mobility, energy, finance and health, where it has envisaged that businesses will be able to access large data sets, as well as technical tools and infrastructure to use and exchange information.
The Commission also hinted towards a new Data act, which has the potential to be brought forward in 2021, which could result in a mandate for business to business sharing in some circumstances. This act also has the potential to change existing property rights frameworks including laws on database rights and on the law of trade secrets.
One of the major data strategy proposals is centred around cloud computing. With the commission stating it wants to create a single ‘cloud rulebook’ by the middle of 2022, which will include codes regarding data protection, portability, quality of service and energy efficiency. There are also further plans for the creation of an EU cloud services marketplace by the end of 2022. This will put users (particulary SMEs and the public sector) in the position to be able to choose cloud processing software and platform service offerings that comply with a number of areas like data protection, security etc.
Regulation of AI
As industries across the board increasingly utilise AI into their services to streamline their processes and improve customer services. The EU has begun to set its sights on AI, with the Commission recently publishing papers indicating their will be further regulations and legislation to account for the use of AI.
The papers stated that existing legislation in areas such as liability, product and safety could be improved.
The Commission seeks to create a bespoke system of rules established for ‘high-risk’ AI, accompanied with criteria that make the distinction between AI that is ‘high-risk’ and those which are not. With criteria looking at the sector in use and what the AI is used for. This is to prevent divergent national rules from emerging, that are likely to create obstacles for companies that want to sell and operate AI systems in the single market.
Regulatory requirements will not just be used during AI operation but there also plans to be a ‘ prior conformity assessment’ framework, which would verify and ensure that regulatory obligations are met before the technology is put in use. This procedure would include checks for testing, inspection and certification. The type of data used will also be investigated including the type used to train AI systems, data and record keeping obligations.
The frameworks will be established to who is (are) best placed to address any potential risks, so this applies both to those developing the AI systems and those deploying the technology.
As well as prior conformity assessments the regulations will also allow for post-market monitoring and enforcement by national regulators.
The Digital Single market strategy is a wide-ranging group of individual legislative initiatives from the European Commission to adapt the European market to the digital age. The primary aim of this initiative is to create a pan-European framework of laws for the digital economy, with the core principles of the single market at focus. This includes free movement of goods, services, people and capital, fair competition and well harmonised level playing field for all stakeholders.
The DSM will be built upon four very familiar EU rules:
1) Harmonised rules: applying the same minimum standards to the same activities (eg handling of consumer data, content of digital services) across all Member states making it easier for citizens and business to conduct their activities regardless of borders.
2) Reduced barriers: Making it easier to treat key ‘assets’ of the digital economy, like content they acquire and their own personal data. Thus increasing rights to move these assets across national borders or from one service to another.
3) Co-ordinated enforcement: Cooperation between those responsible for enforcing the rules locally, at Member state level or EU wide combined with ‘passporting’ (meaning compliance with the rules in one state covers the whole EU) thus increasing confidence for businesses and citizens that they can trade EU wide. And it reduces the costly need to establish compliance systems for multiple countries.
4) Economies of scale and robust competition: To be able to compete on the global markets, EU-based businesses should (a) be able to serve the entire EU market without having to duplicate infrastructure or seek local licenses, and (b) be subject to robust competition from both EU based and non-EU based players. With competition in the EU-wide market leading to the emergence of EU digital champions able to compete on world markets.
The new Von der Leyen Commission has further developed the 16 initial initiatives to streamline the DSM to four key areas:
1) Data protection: Individuals shall gain more control over their personal data and businesses shall benefit from a level playing field
2) eCommerce: Online barriers shall be broken down so that people enjoy full access to all goods and services offered online by businesses.
3) Digital Networks: High speed, secure and trustworthy infrastructures and services shall be supported by the right regulations.
4) European Digital Economy and Society: Maximising the digital growth potential within the EU to the benefit of the people and businesses in Europe
These initiatives will cause some changes to businesses and consumers:
Who and how will be effected by the changes in Online Content and Platforms:
Content owners and licensees will need to review the entire production chain starting with the acquisition of content, the making available of content, structure of websites, the protection of content etc
Clients will have to review their business models, looking at whether those who will work int the future because of added regulatory burdens and changes in sourcing costs due to different exploitation rights and different exemptions/limitations.
Who and how will be effected by the changes in Privacy and Data:
All industries who are engaged in data management or processing are affected, in particular the cloud industry and those using AI or data analytics.
Likely to be new rules for AI
High fines in regard to data protection infringements
Less restrictions on the flow of non-personal data between businesses.
Encouraging the sharing and opening of data between businesses and the public sector.
On the 13th February 2020, the UK’s Food Standard Agency issued a deadline for CBD businesses to provide more information about their CBD products. It also published safety advice to consumers particularly vulnerable groups not to take CBD and healthy adults not to take more than 70mg a day. This announcement comes as CBD products become more widely available on the high street but are not properly authorised.
The FSA set a deadline of 31st March 2020, to submit valid novel food authorisation applications. After this deadline only products which have submitted a valid application will be allowed to remain on the market. Up to the deadline date, businesses should be able to sell their CBD products provided that during this time they are not incorrectly labelled, unsafe to eat or contain substances that fall under drugs legislation.
The FSA also advised that those who are pregnant, breast-feeding or taking any medication not too consume CBD products. And for healthy adults to think carefully before taking CBD with the FSA recommending that no more than 70mg a day (about 28 drops of 5% CBD) unless under medical direction. With these findings coming from the Governments Committee on Toxicity.
What is CBD
CBD is a chemical found naturally within the cannabis plant and it has only recently been removed and sold as a separate CBD extract. CBD extracts can be found in a range of products such as drinks, confectionary, oils and bakery products.
CBD was as also confirmed as a novel food product in January 2019. Under these novel food regulations, foods or food ingredients which do not have a history of consumption before May 1997 should be evaluated and authorised before they can be placed on the market.
The FSA is now responsible for regulating CBD as a novel food and does not have enforcing power over cosmetics, vapes, products making medicinal claims or products containing controlled drugs such as THC. Where CBD extracts contain THC ( or other controlled cannabinoids then they will likely fall under the Misuse of Drugs Act 1971.
With the Coranavirus recently declared a ‘global threat’ by WHO and now officially surpassing the SARs virus for deaths and number of people affected. This pandemic now represents a real threat to the pharmaceutical supply chain as well as the health of the population at large.
China is an integral part of the supply chain, with it being the world’s largest supplier of active pharmaceutical ingredients (APIs) being responsible for around 40% of global production to supply the ingredients for the makers of generic and innovator drugs alike. In the UK, 80—90% of the generic medicines used in the NHS are imported and China is among the top five providers outside the EU. This dependency has arisen from the cost-saving incentives that Chinese pharmaceutical markets offer.
Although most Chinese drug manufacturers are based along the east coast a long way away from the Wuhan province. The virus has since been detected in every province. With imposed measures such as a diminished workforce, growing number of travel bans and other countermeasures such as potential international embargos, presenting uncertain sustainable production levels. The full scale of the impact is unlikely to be known until many months to come.
The pharma industry has already begun to respond to the pandemic, such as companies like Inovio Pharmaceuticals and Moderna developing vaccination programmes with the help of the Coalition for Epidemic Preparedness Innovations (CEPI)
GSK has made its adjuvant technology available to help the University of Queensland, to expand its rapid vaccine production system. The adjuvant should reduce the amount of antigen necessary for each vaccine, allowing more people to be treated faster with available antigen supplies. GSK is not the only major pharma company to make strides into Coranavirus vaccination, with Gilead making efforts to re-purpose its drug remdesivir, originally developed to treat Ebola with recent reports allegedly claiming it has received light from the Chine Food and Drug Administration for a clinical trial to take place in Wuhan.
The UK exits the EU on 31st January 2020. By virtue of the transitional period in the Withdrawal Agreement, EU law will continue to apply in and in relation to the UK only until the 31st December 2020. The EU Treaties, EU free movement rights and the general principles of EU law will then cease to apply in relation to the UK, and prior EU regulations will only continue to apply in domestic law insofar as they are not modified or revoked by regulations under that 2018 Act.
IP law is one of the most harmonised law networks across the UK and Europe, with a large majority of the UK legislative framework composed of directly effective EU Regulations and Directives. Depending on the type of Brexit envisioned by PM Boris Johnson, if these regulations are not transposed they face entering into a regulatory vacuum.
The European Union Withdrawal Act 2018, will fully come into action on January 31st and it will repeal the European Communities Act 1972. The act includes provisions to convert currently directly applicable EU laws into domestic UK law. MPs will then go through each law and decide whether to amend or repeal them, based of national interests.
Implications of Brexit still remain very uncertain and are likely to be effected by both the repeals and amendments of EU laws as well as the terms of international agreements negotiated. This following post will cover three of the main implications of Brexit.
Patent approval will continue to remain as before, with patents covering the UK able to be granted by both the UK Intellectual Property Office (UKIPO) and the European Patent Office (EPO). This is because neither EPO or UKIPO are EU institutions therefore their operation will be unaffected by Brexit. The UK will continue to be a member of the 38 contracting states to the European Patent Convention (the treaty that established the EPO), therefore companies will be able to continue to file their applications with the EPO and request validation in countries of interest including the UK. The outcome of granted patents will continue to remain the same, with granted and approved patents for the UK having the same legal effect in the UK as national patents granted by the UKIPO.
There plans to be an introduction of a new Patent regime which is intended to provide patentees with the option to apply for pan-EU Unitary Patent, covering the majority of the EU. Through this regime the Unified Patent court will be created (UPC), which will hear and determine patent disputes on an EU-wide basis. (UPC).
This regime has faced challenges in its implementation, where its future was uncertain after Brexit and is currently delayed in the German courts. The UK ratified the UPC agreement in 2018, (UK ratification is needed in order for the system to launch) .The message from US companies and practitioners clearly is that the UPC would be less attractive without the UK. Patent law is a global playing field in which the US, Europe and Asia are the main regions and direct competitors. It does seem to be in the best interest of Europe if the UPC covers the largest possible territory; at least this seems to be a clear industry position. UPC is not an EU instrument and it remains legally possible for the UK to remain a member; it is whether politically there will be tensions.
Life Science Regulation
The UK’s life science regulation has already been affected by Brexit, with the European Medicines Agency which was previously based in London moving to Amsterdam. With a “soft Brexit” of continued affiliation with the current system rejected by the government, organisations have to be ready to adapt to the regulatory framework that will be reshaped.
One of the biggest worries facing the UK pharma industry would be the exclusion of the UK from operating in the European Digital Single Market (DSM). This market was created to promote common data practice laws, greater acceptance of digital services and better access to products and services. The DSM is of particular importance to the UK because currently the EU is the UKs largest export market for digital services and the DSM allowed for easy entry to the European markets. Therefore, Brexit has a substantial effect on the data protection, privacy and creative content production as UK service providers may lose their passports to EU markets because companies need an EU headquarters to access the service market.
Brexit is going to be a complicated affair for all businesses in the UK but the IP field faces harsher implications of tougher negotiations. With recent statements made by the Chancellor Sajid Javid that the UK will deviate from EU laws, this would create woes for the UK IP industry, given the high interconnected trade and harmonisation. The UK will not be able to influence EU policy potentially undermining the position of UK based IP and IT companies in both Europe and the world stage (especially with the US considering the UK may be seen as a second class citizen without a voice in Europe) ultimately making it more difficult to compete.
Pfizer is launching three Roche cancer blockbusters generics at discounts ranging from 22% to 24%. Pfizer is eyeing the lucrative combined $10bn that the three drugs accumulated at their peaks. With Pfizer having already rolled out its biosimilars to Roche’s Avastin and Rituxan at discounts of 23% and 24% respectively. The pharma company has now announced its plans to launch its biosimilar to Trazimera at a 22% discount on the February 15th.
Pfizer has always been an active player in the biosimilar market and with this recent announcement it will be the first company to market three oncology monoclonal antibody biosimilars in the US. However not all of Pfizers biosimilar releases have been met with success, with its 2016 launch of Inflectra (a biosimilar to J&Js blockbuster immunology med Remicade) coming to a spluttering start as it could not gain any traction against competition.
Pfizer consequently sued J&J for making “anti-competitive” deals with payers that blocked out biosimilar competition. With Pfizer claiming that Roche tied rebations of Remicide to payers provided they did not use biosimilars. US sales have picked up since for the biosimilar reaching $280 million in the first nine months of 2019, but this pales in comparison to the $2.32bn take-in for Remicade over the same span.
Since that rollout, Pfizer has managed to gain some success as it launched Retacrit, a biosim to J&Js Procrit, at a 33% discount. With Retacrit gaining a 16% market share, the most of any biosim in the US. Pfizer stated that this experience gave them the opportunity to learn what it takes to launch an oncological biosimilar as well as what to expect in that space.
It will be a tough challenge for Pfizer as it enters the Roche biosimilar market, with there already being competition from the Teva-Celltrion team for Rituxan and competition for Avastin against Amgen and Allergan.
The negotiations between the US, Canada and Mexico have reached an agreement to scrap patent exclusivity for biologics, meaning that each country can decide its own rules.
Previously the US had also negotiated favorable trade agreements regarding the pharmaceutical industry and have always pushed its exclusivity rules to its trade partners (previously 12-year patent exclusivity for biologics.) This change now means that pharma companies will not have the luxury of a 10-year period to keep data and other information related to their drugs confidential or have longer pricing monopolies on the market.
According to Politco, this final agreement arose from the need to compromise to end the deadlock between the Republican and Democratic party.
Responding to these recent developments, industry organisation's BIO’s president and CEO stated that removing these IP protections for biologic medicines will not end foreign free riding on American innovation. And puts small pharma companies in jeopardy that depend on the government to protect them in the global markets.
This trade agreement might set a worrying precedent for pharma companies in future trade deals globally, meaning that global drugmakers could face sooner-than usual competition from biosimilars.
GSK, Pfizer and Sanofi are some among the many drug-makers planning to implement price hike in the US
According to a report from Reuters, these three companies among others are planning to increase the price of around 200 drugs in total. The planned price hikes were revealed by healthcare research firm Axis Advisors. According to Axis, the median price increase of these drugs is set to be around 5%, with around half of them in the 4%-6% range.
This is a bold move by pharma companies, amidst the political discourse and intense public scrutiny over prescription drug prices in the US. Drug prices have been a key issue for both Trumps administration and the opposition Democratic party, and it would come to no surprise if it dominated the election campaign in 2020.
GSK will increase prices of around 30 of its drugs including its Ellipta inhaler, cancer drug Zejula and various products from its HIV division ViiV healthcare. Pfizer has planned price hikes for over 50 of its drug, including inhibitor molecule Ibrance, which grew by 27% to $1.3bn in the last quarter.
Both American parties have come up with plans to tackle the pricing epidemic currently rampant in the US. In July, Trump unveiled plans to allow the re-importation of certain drugs from Canada, which has since been advanced last month. This draft guidance would allow states in the US to import prescription drugs from Canada. While the Democrats have recently passed a bill through the Senate targeting 250 high-cost drugs that would be subject to cost-cutting negotiations by Medicare.
Both plans have been met with harsh criticism, with industry body PhRMA hitting back at the Democrats plan, stating that it “ would end the current market-based system that has made the US the global leader in developing innovative, life-saving treatments and cures.” There has also been skepticism from industry experts regarding the pharma industries willingness to sell more drugs to Canada so that the US can import them at cheaper prices.
From all this political scrutiny, the most recent drug prices although they have drawn criticism, they are substantially lower than historical price hikes. With major pharma companies sticking to the cap of 10% drug price increase, whether this can be attributed to the increased scrutiny remains to be seen.
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