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Pharma - Patent Cliff Looms Large
Despite the global economic outlook improving considerably over the last year, the latest annual life sciences research from Marks & Clerk reveals a number of industry-specific problems. The most pressing of these is the looming patent cliff facing pharmaceutical companies. Large numbers of blockbuster drugs are set to come off-patent between now and 2014, which is pushing the industry into a critical phase in terms of drug innovation and consolidation. The findings, based on a study of 381 executives across the pharmaceutical and biotechnology sectors, show that big pharma is becoming increasingly reliant on patent term extensions (or Supplementary Protection Certificates (SPCs) in Europe) to safeguard essential blockbuster revenue ahead of a likely 'make or break' roun d of company acquisitions. Now that the gains from yesterday’s small molecule-based drug discovery have been largely enjoyed, the picture for R&D is now far more complex. 87 percent of respondents predict that big pharma will be unable to innovate sufficiently from within to replenish dwindling drug pipelines, leading to an increase in acquisitions. 68 per cent forecast substantial acquisition activity within the next two years, with almost one fifth anticipating major activity within the next year.
The European landscape
Moving away from the practical considerations of the approaching patent cliff, respondents expressed concerns over a number of regulatory and policy issues facing the sector, emanating from both the European Commission and the European Patent Office (EPO).
In July 2009, the European Commission published its report following a sector enquiry into alleged competitive abuses , delaying the market entry of generic competition. The Commission rejected root-and-branch reform to the IP system, however, and instead launched a series of targeted probes where it felt there to be abuses.
Nearly two thirds (64 per cent) remain of the view that European policymakers are fundamentally hostile towards secondary patents for follow-on drug development. Over three quarters (78 per cent) suggest that critics of secondary, follow-on drug development do not give sufficient recognition to the role incremental innovation plays in advancing medicine.
However, the European issue of predominant concern to respondents related to changes affecting their patenting strategies. In April 2010, the EPO made rule changes which significantly affect patent examination procedure and the availability of divisional filings, designed by the EPO to vastly increase the speed at which patent applications are processed and thus reduce patent backlogs. < br />
Respondents are in broad agreement that the measures – which will force companies to make more concrete decisions about the future direction of their R&D and patenting strategies at an earlier date – are likely to be a particular burden on smaller companies with more limited resources (82 per cent). This is particularly worrying given that, as we approach the end of the ‘small molecule era’, the blockbusters of the future are likely to hail from smaller biotechnology outfits – the very organisations hit hardest by these reforms.
A rejuvenated US market
In stark contrast to the concerns around Europe, there is considerable optimism regarding the US. Surprisingly, that optimism even extends to President Obama’s healthcare reforms – now The Health Care and Education Reconciliation Act 2010 which was seemingly on the rocks only a few weeks prior to its passage in April.
A majority of respondents rejects the notion that this reform will ultimately harm drug innovation in the US, with just over 65 per cent contending that margin reduction will be offset in the long run by increased sales or that the reforms ill even benefit innovation. Furthermore, 88 per cent support the longer term given to complex biologics in the bill (of twelve years data exclusivity), arguing that this creates the right level of incentive for R&D (as opposed to a five-year term for conventional small molecule products). Lastly, a compelling majority of 89 per cent suggest that the certainty provided by US healthcare reform will result in lasting capital being attracted back into the US market in the long un – presumably at the expense of other major markets, such as Europe.
Taken together, the findings suggest that we are continuing to see a more hospitable environment for drug innovation in the US than Europe. There is a clear fear that the gap in securing and exploiting innovation between the US and Europe may grow, and that – in Europe at least – the future innovations in medicine needed to promote health may be compromised. Dr Gareth Williams
For a copy of the full report, contact Jo Colton at Marks&Clerk
Conditional CE Marking - A Pathway to Innovation?
The European Commission’s public consultation on proposed revisions to the In Vitro Diagnostics Directive (98/79/EC) makes reference to “conditional CE marking,” reports Clinica. And that has generated some buzz at Eucomed and within the larger medtech community. Section 5.1 of the consultation states the following:
"For unmet medical needs of patients, for example in the case of rare diseases or in emergency situations such as a pandemic, it might be useful to introduce a mechanism which can allow a rapid market access of certain IVDs subject to certain conditions. Currently, Article 9(12) of Directive 98/79/EC makes provision that Member States can accept IVD s in their respective territories without proper conformity assessment procedure if this is justified in the interest of public health protection. Instead of such national solutions, a “conditional CE marking” might be allowed for a limited period of time (e.g. one year renewable) and subject to specific obligations imposed on the manufacturer with a view to confirm the safety and performances of the tests."
Although this would only apply to IVD products, it has captured the imagination of John Brennan, Director of Technical and Regulatory Affairs at Eucomed, who told Clinica that this “could be an interesting vehicle for innovation in Europe"
Financing a Private Sector Recovery
The Government recognises that access to finance is critical for businesses to survive and grow and that small and medium-sized companies face particular challenges. The current system is not adequately delivering finance to small, growing businesses that are vital to the future of the economy.
The Business Secretary and the Chancellor want to work with business and the financial community to ensure that access to finance is not a barrier for companies looking to invest and boost the growth of the economy.
The paper, Financing a Private Sector Recovery, sets out the range of finance options for different sized businesses, explores where the market is failing to provide and if there is a role for government intervention. It launches an intensive discussion on how business and the government can work together to produce a diverse, competitive and sustainable financial environment.
Download the consultation
FDA Increases Recall Power Under Proposed Device Changes
Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year.
The FDA released recommendations Monday night designed to improve oversight of the U.S. device industry, including the government's ability to recall products that prove unsafe or ineffective.
The FDA's report comes nearly a year after FDA's medical devices division endured a storm of criticism from public health advocates and lawmakers.
Last August, the head of the device division resigned, months after scientists under his leadership alleged they were pressured to approve certain products. Last year began with congressional investigators saying the FDA should take immediate steps to make sure more devices are reviewed through the most stringent process.
The recommendations come from two internal FDA panels that were tapped to draft changes in the wake of the outside criticism. The FDA is not bound by the reports, and will accept public comments for 90 days.
FDA's critics said the recommendations are a positive first step, but that they hoped for bolder action from regulators.
At the centre of the overhaul is the nearly 35-year-old system the FDA uses to grant speedy approval to devices that are deemed similar to products already on the market.
The FDA's panel recommends the agency clarify when a device is sufficiently similar to those already on the market to receive 510(k) clearance. The group also recommends that manufacturers be required to submit a summary of all available safety information about their device, instead of just the basic information required under current regulations.
But industry observers note there are aspects of the proposal that could also smooth the regulatory process for companies. The FDA's panel suggests issuing regular guidance letters to update the industry on changing submission requirements for various devices.
FDA officials said some of the changes to its approval system could be made in coming months, but more sweeping changes could require new legislation from Congress.
Source:qmed.com
Mandatory Recalls Under New FDA Bill
The FDA could enforce mandatory recalls of drugs and assess civil penalties under new legislation introduced by Sen. Michael Bennet (D-Colo.) that gives the agency more authority over pharmaceutical quality management and supply chain control. The Drug Safety and Accountability Act of 2010, S. 3690, introduced by Bennet this week, also would increase the agency’s enforcement authority by giving it subpoena power and allowing it to share information relevant to public health with other regulatory agencies.
Source:fdanews.com
Profile Your Company to Professional Medical and Healthcare Technology Buyers - Globally!
The ECRI Institute opened its European Office in Welwyn Garden City in May 1995 with the goal of serving the particular needs of UK and Europe. Established originally in 1955 as the Emergency Care Research Institute in Plymouth Meeting Philadelphia, it is one of the foremost Healthcare research Agencies in the world.
ECRI has over 5,000 members and clients including public and private hospitals, health systems, government agencies, minstries of health, voluntary sector organisations, professional associations and accrediting agencies worldwide.
ECRI members utilise the database of medical and healthcare technology companies, who can upload details of their company, areas of specialism and product specifications, completely free of charge.
This data is used by thousands of procurement professionals across the world to source, compare and evaluate the whole range of medical and healthcare equipment used throughout the care pathway.
There is no better way for you to profile your product or technology to the healthcare and medical professionals who use ECRI to seek out manufacturers appropriate for their needs.
If you would like to take advantage of this opportunity, please contact Michael Stewart of ECRI UK
Tel: 01707 831001 ext 520
Email: mstewart@ecri.org.uk
New Procurement Scheme of Suppliers
As a beneficial service to their members Bionow are in the process of setting up a procurement scheme of suppliers who are able to offer preferential rates or discounts to Bionow's membership of over 400 biomedical and related companies. There will be NO CHARGE for inclusion within the list. Bionow aim to use our regular channels of communication such as this newsletter, linked in group and events to promote the scheme and we hope it will prove to be successful for both the member companies and suppliers.
Bionow are currently looking for expressions of interest from suppliers from all types of business-to-business products/services that would be relevant to our membership. They are unable to accept suppliers of products or services that would be deemed to be personal (e.g. home in surance etc). Suppliers may participate from all geographic areas, not just the Northwest.
Please contact Ben Cliff on 07748 334596 in the first instance or for more information on Bionow, please click here
Big Brother Business - 13 September 2010
If you run your own business and wouldn't mind sharing your journey with other entrepreneurs, then a new business website launching in the West Midlands wants you!
The Big Brother style business website or 'webumentary' as its founders Andrew Springhall and Toby Reid refer to it, profiles the trials and tribulations of three fledgling businesses filmed through different stages of their journey, using live Twitter feeds, videos and blogs. From naming their business through to frustrating first meetings with banks, the businesses featured on the website lay themselves open for others to watch and follow online.
After a successful trial in the East Midlands, they will be launching in the West Midland this Autumn and its founders re currently scouring the region for West Midlands based businesses to take part.
Toby Reid, co-founder says, " The reduction in public sector funding for entrepreneurs announced earlier this month means that many small and medium-sized businesses will need to seek out alternative ways to find business support locally. We believe our website fills that gap.
Being featured on inafishbowl gives businesses a unique opportunity to share their story with a fast growing audience whilst receiving free ongoing expert advice and guidance from a wide ranging panel of experts and celebrity mentors including ex-Dragon Rachel Elnaugh, Apprentice start Claire Young and Secret Millionaire Ben Way."
"We urge local businesses to apply. If you are successful, you will be featured on the site for a period of 6 months, giving you the exposure that your PR and marketing efforts may have thus far struggled to achieve on a small business budget."
"Eligible firms can apply online at inafishbowl. The only stipulations are that the company must be less than five years old, already trading (no matter how small) and that they must be willing to share their business experiences and lessons in an open and honest manner - warts and all!"
Interview and assessment days will be held in the West Midlands on 13 September 2010 - please see the website for details on registering your interest.
Medical Device User Fee Act Meeting - Request for Comments 14 September
Meeting: Medical Device User Fee Act
Date and Time: The public meeting will be held on 14 September 2010, from 9 a.m. to 5 p.m.
Location: FDA is currently in the process of determining the meeting location, which will be in the Washington DC metropolitan area. When the location has been determined, FDA plans to publish a notice in the Federal Register that will provide the address of the meeting location.
The Food and Drug Administration (FDA) is announcing a public meeting on the reauthorisation of the medical device user fee program. The current legislative authority for the medical device user fee program expires in September 2012 and new legislation will be required for FDA to continue collecting user fees for the medical device program.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on medical device user fee program reauthorisation, they publish a notice in the Federal Register requesting public input on the reauthorisation, hold a public meeting at which the public may present its views on the reauthorization, provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes, and publish the comments on FDA's Web site. FDA invites public comment on the medical device user fee program and suggestions regarding the commitments FDA should propose for the next reauthorized program.
Contact Person: James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1609, Silver Spring, MD 20993, 301-796-6313, FAX: 301-847-8121
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