The Medical Technology Blog

Welcome back to the Medical Technology Blog. Today’s article comes from the Cardiovascular Device Business Newsletter from Espicom Business Intelligence.

VentriPoint Diagnostics has met with the FDA to review its plans for the clinical trial and regulatory submission for the first application of the VMS heart analysis system for the congenital heart disease known as Tetralogy of Fallot. The FDA informed the company it had answered all its questions and addressed all of the earlier observations pertaining to the trial, paving the way for the start of the trial in the US.

The Tetralogy of Fallot study has begun in the US and is designed to show substantial equivalency between the gold-standard, MRI method and VentriPoint’s 2D-ultrasound, VMS technique. Based on advice from the FDA, the study has been designed to collect images at multiple sites and to analyse them in core labs. Nationwide Hospital in Columbus, OH is the lead centre for the study and the University of Nebraska has been named as a second site. A number of other clinical sites are expected to join the study. Nationwide Hospital has also been selected as the core lab for the analysis of MRI studies and the Hospital for Sick Children in Toronto, Canada has been selected to carry out all the analyses of the studies.

To date, 20 patients have been enrolled in the study and a total of 75 evaluable cases are required for study completion. VentriPoint anticipates enrolment will accelerate as the other centres become operational. The data collection should be completed this spring and a response from the FDA is anticipated this summer, depending on the rate or recruitment by existing and new centres.

VentriPoint estimates the market for product for Tetralogy of Fallot to be US$200 million and is already marketing the device in Europe and Canada, where it is approved for clinical use. The company has a target of placing 50 VMS devices in 2012 and anticipates that sales will increase rapidly during 2012 should FDA approval for Tetralogy of Fallow is achieved and approval for pulmonary hypertension is received in Europe and Canada.

The pulmonary arterial hypertension application is expected to over lap with the US congenital heart disease programme. A clinical evaluation of the pulmonary arterial hypertension application has already begun at the University of Chicago. This should be complete in a few weeks and, if successful, VentriPonit will use the data to file for CE mark and Canadian approval marketing applications. A number of medical centres have agreed to be part of this pivotal trial. Based on experience with the Tetralogy of Fallot trial, the company has already started the IRB and budget-approval processes with these major cardiovascular centres, as this is the most time-consuming part of the process. The sites will be selected shortly and will become operational as soon as possible.

Much of 2011 has been spent upgrading both hardware and software based on the feedback from the users and developing new applications such as pulmonary hypertension. The latest software, version 1.1, is completed and undergoing final testing. The major hardware feature expansion is the ability to interface with the newer digital ultrasound machines, which the company says is likely to  take over the market in the next five years. A key software enhancement is the ability to export VMS studies to the hospital PACS, enabling third party DICOM viewers to review the VMS results. Existing sites will be updated remotely with the new version as soon as it has been released for general use.

Looking ahead, VentriPoint is actively seeking partnerships with large manufacturers of ultrasound equipment for combination products and distribution. The company says there is considerable interest in developing a stand-alone system for pulmonary hypertension, as this would be a completely new application for ultrasound.

Article source: Lawrence Miller, editor Cardiovascular Device Business, and medical newsletters team leader at Espicom Business Intelligence



Espicom Business Intelligence

Libyan Medical Market Report

The Medical Technology Blog

In the light of recent world developments, Espicom Business Intelligence has just released a new report entitled The Libyan Medical Market: Status & Post-Conflict Opportunities. This report has been compiled from novel forecasts and original materials to give a complete overview of the Libyan health market. Together with the fall of the Gaddafi regime as well as the expected introduction of a more open-handed democratic government, it is time to scrutinize Libya’s medical market economy in the region, examine the way it may develop, and assess the impacts for medical technology companies.

Libya is a small but oil-rich country in North Africa. Under the personal rule of Muammar Gaddafi from 1969 to 2011, it developed an eccentric mixture of socialism and Islam. The country was largely isolated from the international community due to its terrorist links, although Gaddafi made concerted and largely successful moves to re-engage with the West in the 2001-10 period.

2011 saw a bloody but ultimately successful rebellion against Gaddafi’s rule, caused by declining living standards over the past two years, and inspired by the Arab Spring uprisings in neighbouring countries such as Egypt and Tunisia. Aided by NATO airpower, anti-Gaddafi forces based in Libya’s second city, Benghazi, were able to take Tripoli in August 2011, and the whole country by October.

Libya’s oil wealth has enabled it to create a reasonably comprehensive healthcare system, but spending remains low in comparison with other oil-rich countries of comparable income such as Saudi Arabia. There is therefore considerable scope for expansion and modernisation in the future. There is no private insurance as such, so local people are largely reliant on the public hospital system. There is a well-equipped private sector, which caters for wealthier locals and workers in the oil industry.

The 2011 fighting has caused serious dislocation in the health sector, at the same time as placing great strains upon it. Some facilities have been directly damaged, while others have faced shortages of power, equipment, supplies and personnel. Most services have remained open, however, and the transitional council in Benghazi established a health ministry early on, in order to restore some normality. Shortages have become far less acute in the latter part of 2011, helped by short term overseas aid and the unlocking of public funds for use by the transitional government.

Libya makes some drugs locally, but has no significant domestic production of medical equipment, so all its requirements have to be met by imports. These were boosted by the thawing of relations with the EU and USA in 2003-04, since when direct trade became far easier. Imports peaked at just under US$200 million in 2009, but fell back in 2010 to US$146 million or US$22 per capita. Around three quarters is sourced from the EU, principally Germany and Italy. Despite the fall in 2010, Libya remains by some margin the leading African importer of medical equipment in per capita terms, ahead of larger economies such as South Africa or Egypt.

Understandably, the fighting in 2011 had a severe effect on the Libyan medical market. Imports shrank to almost nothing in the March to July period when trade became difficult, not least due to the freezing of government finance. With the fall of Tripoli in August and the death of Gaddafi in October, some much-needed stability has returned and a rapid rebound to pre-2011 levels of spending can be expected as the new government – and the private sector – restock and re-equip. Looking further forward, Libya has the opportunity to use its oil wealth to create a sophisticated and advanced health sector in the style of the Gulf states, assuming a degree of political will and ongoing political stability. The latter is far from a certainty, but the prospects appear far brighter post-Gaddafi than under his rule.

To purchase, or read more on this new report please click on the link to The Libyan Medical Market: Status & Post-Conflict Opportunities.


Mouse here for
Related Links



Espicom Business Intelligence

FDA steps up bid to drive innovation in healthcare

The Medical Technology Blog

The FDA has handed over an award of US$2 million…

…to support two regional ‘Centres of Excellence in Regulatory Science and Innovation’ (CERSI) in the US. The centres, which will be located at the University of Maryland and Georgetown University, will focus on strengthening science and training needed to modernise and improve the ways drugs and medical devices are reviewed and evaluated.

In August 2011, the agency released the strategic plan for “Advancing Regulatory Science at FDA”, the main focus of which was to accelerate delivery of new medical treatments to patients, improve paediatric health, protect against emerging infectious diseases and terrorism, enhance safety and health through informatics, protect the food supply, modernise safety testing and meet the challenges of regulation. More recently, in October, the agency announced a related initiative, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients”. This plan focuses on “continuing dialogue with companies, innovators, patients and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation”.

Working with FDA scientists, CERSI researchers will assist the FDA in driving innovation in medical product development as well as in advancing laboratory, population, behavioural and manufacturing sciences. The agency chose to pilot the CERSIs in Washington, DC, to allow for the greatest possible face-to-face collaboration and training with FDA staff.

Thanks to Sophie Bracken for this article, Sophie is editor of Espicom’s business publication Drug Delivery Insight.


Mouse here for
Related Links



Espicom Business Intelligence

Medical Futures & Cipher Pharmaceuticals in Tramadol Deal

The Medical Technology Blog

Medical Futures to gain a slice of Canadian tramadol market through deal with Cipher

Medical Futures, a Canada-based pharma company, has signed a pact for Cipher Pharmaceuticals to distribute Durela in Canada. Patent-protected Durela is a once-a-day formulation of tramadol for the treatment of moderate- to moderately-severe chronic pain in adults. It was approved by Health Canada in August and has immediate- and extended-release properties.

As for the particulars of the distribution deal, Cipher will receive an upfront payment from Medical Futures of C$300,000, and could also be eligible for future payments, dependant on net sales milestones. Also, Cipher will get its hands on a double-digit royalty on new sales. Cipher has further responsibily for product supply and manufacturing, which will be taken care of by its supplier, Galephar Pharmaceutical Research.

Medical Futures’ CEO, Colin Campbell, says he is excited to offer Durela in Canada, believing that the product “strengthens and demonstrates [Cipher’s] commitment to providing top tier solutions to the Canadian market”. It appears Cipher is equally delighted with the deal, as it provides valuable royalty revenue to the company. Cipher also recently shook hands on a US$5.5 million US distribution deal for Durela with Vertical Pharmaceuticals, with the former set to receive a payment of US$1 million on the first commercial sale of the product.

With sales of over US$60 million in 2010, the seemingly robust Canadian tramadol market looks like a sure thing for both parties. Medical Futures plans to launch Durela in the first quarter of 2012.

Thanks to Sophie Bracken for this article, Sophie edits Espicom’s business publication Drug Delivery Insight.



Espicom Business Intelligence

US researchers uncover protein associated with heart attacks

The Medical Technology Blog

Today’s post on the Medical Technology Blog come from Medical Industry Week, Espicom’s current business publication on the medical industry, please read on…

Researchers from Loyola University Chicago Stritch School of Medicine have discovered a possible new blood test to help diagnose heart attacks.

Featured within the Journal of Molecular and Cellular Cardiology, the investigators provided details of a large protein known as cardiac myosin binding protein-C (cMyBP-C), which is released to the blood following a heart attack. Senior author, Dr Sakthivel Sadayappan, believes this could potentially become the basis for a new test, used in conjunction with other blood tests, to help diagnose heart attacks, however, additional studies will be necessary to establish cMyBP-C as a true biomarker for heart attacks.

Between 60 and 70 per cent of all patients who complain of chest pain do not have heart attacks. Many of these patients are admitted to the hospital, at considerable time and expense, until a heart attack is definitively ruled out. An electrocardiogram can diagnose major heart attacks, but not minor ones. There are also blood tests for various proteins associated with heart attacks, but most of these proteins are not specific to the heart. Elevated levels could indicate a problem other than a heart attack, such as a muscle injury. Only one protein now used in blood tests, called cardiac troponin-I, is specific to the heart, however, it takes at least four to six hours for this protein to show up in the blood following a heart attack.

 The Loyola study is the first to find that cMyBP-C is associated with heart attacks. The researchers evaluated blood samples from heart attack patients, and also evaluated rats that had experienced heart attacks. They found that in both humans and rats, cMyBP-C was significantly elevated following heart attacks. cMyBP-C is a large assembly protein that stabilises heart muscle structure and regulates cardiac function. During a heart attack, a coronary artery is blocked, and heart muscle cells begin to die due to lack of blood flow and oxygen. As heart cells die, cMyPB-C breaks into fragments and is released into the blood. Future studies would determine the time course of release, peak concentrations and half life in the circulatory system. Sadayappan holds a provisional patent to determine the risk factors associated with cMyBP-C degradation and release into human body fluid.




Espicom Business Intelligence

Cardiovascular Device Business News

The Medical Technology Blog

Photograph of the Taxus drug-eluting stent, fr...

Image via Wikipedia

Last post of the week in The Medical Technology Blog comes from the Cardiovascular Device Business, Espicom’s business publication. Please read on…

Swedish researchers compare risk of stent thrombosis and restenosis in new vs old DESs

Findings from the complete Swedish Coronary Angiography and Angioplasty Registry (SCAAR) have demonstrated that percutaneous coronary intervention (PCI) with ‘new generation’ drug-eluting stents (DESs) was associated with a 38 per cent lower risk of clinically meaningful restenosis and a 50 per cent lower risk of stent thrombosis compared with ‘old generation’ DESs.

Although many trials and studies support the overall early- and mid-term safety and efficacy of first-generation DESs, there has been concern regarding their long-term safety, especially regarding the potential risk of late stent thrombosis as well as late restenosis. New drug-eluting stents (n-DESs) have been developed with the purpose of overcoming the current limitations of the older generation drug-eluting stents (o-DESs).

The purpose of this study was to evaluate the long-term outcome in all patients who underwent stent implantation with bare-metal stents (BMS), o-DESs and n-DESs in Sweden, using SCAAR, a national registry with complete consecutive enrolment. The latter holds data on consecutive patients from 29 centres that perform coronary angiography and PCI in Sweden. The registry is sponsored by the Swedish Health Authorities and is independent of commercial funding. The technology is developed and administered by the Uppsala University Clinical Research Center. All consecutive patients undergoing coronary angiography or PCI are included. Information with respect to restenosis and stent thrombosis has been registered for patients undergoing any subsequent coronary angiography for a clinical reason since the beginning of 2004.

The current study included 94,384 stent implantations in Sweden (BMS, n=64631; o-DES, n=19202; n-DES, n=10551), from November 2006 to October 2010. Follow-up was performed up to two years post-intervention. The performance up to two years of different types n-DES was evaluated in an unselected, large, real-world population – including patients with myocardial infarction, three-vessel and/or left main disease, bifurcation lesions, graft disease, restenotic lesions and chronic total occlusions. The main findings from this study are that PCI with n-DESs was associated with a 38 per cent lower risk of clinically meaningful restenosis and a 50 per cent lower risk of stent thrombosis compared with o-DESs. These findings can be useful for the management of patients with a high-risk profile that could benefit more from these new devices.

Further studies are said to be needed in order to attempt to discriminate whether one of the three components of the n-DES – the polymer, the stent alloy, the eluting-drug – is mainly involved in decreasing the incidence of stent thrombosis and restenosis. Improved stent designs with thinner struts and more biocompatible polymers may have an important impact on drug elution profiles, endothelial coverage and functional recovery.



Espicom Business Intelligence

Non-Surgical Treatment for Varicose Veins

The Medical Technology Blog

As the NHS cuts start to bite, could a treatment for varicose veins provide one of the answers?

Maybe not! But Medical Industry Week this week highlighted the rather grand suggestion that a non-surgical treatment for varicose veins could save the UK’s National Health Service over £17 million annually in healthcare costs, and help 7,000 patients avoid further treatment due to unsuccessful alternative treatments. It’s not going to solve all our problems, but if it’s true then it’s a good start!

All medical device companies like to big up their respective device and technologies from time to time, particularly when one considers that regulatory authorities from across the country are tightening the budgets.  So it remains to be seen whether VNUS’ claims are just marketing puff, but it’s interesting to see how companies are increasingly using costing as a sale push, in addition to all the stated benefits of improving healthcare.

Developed by US-based VNUS Medical Technologies, the VNUS Closure Procedure involves a hospital stay of a couple of hours, treatment under local, rather than general anaesthetic, and claims a much faster recovery time with most patients able to walk out of the treatment room unaided. The procedure is also much less resource-intensive than surgery to the NHS, particularly compared to conventional varicose vein stripping, which takes up a great deal of operating theatre time.

For the same costs, the company said this week that a further 25,000 patients could be treated earlier and avoid pain, or discomfort. Further savings are on offer as the procedure can be carried-out in a treatment room so it has the potential to free-up theatre-time, enabling the NHS to treat other serious conditions more quickly and to reduce those all-important waiting-times.

On its own, the VNUS procedure may not represent a significant dent in the £20 billion of spending cuts that the NHS is faced with securing over the next four years, but getting on top of some of these, arguably less glamorous treatments could collectively make a positive impact on meeting this ambitious target. Medical Industry Week argues that it is time to take a closer look at these sort of treatments in a bid to meet a target that even the NHS Confederation says is unlikely to be achieved with the timescale.

This article was provided by Lawrence Miller, editor of Medical Industry Week, and the medical newsletters teamleader.



Espicom Business Intelligence

Zimmer’s cash-saving scheme begins with Statesville site closure

The Medical Technology Blog

 Orthopaedics Business News

Zimmer has put the wheels in motion regarding its plan to close its operations in Statesville, NC as part of a restructuring of its manufacturing facilities.

Warsaw, IN-based Zimmer has filed a notice with the North Carolina Department of Commerce of its impending plans, with the first redundancies widely expected to take place in October. The phase-out of the Statesville plant will be completed in March 2012. It is not clear how many Zimmer employees at the plant will lose their jobs, but the site currently employs around 125 people.

The Statesville facility was opened in 1980 and makes tourniquet cuffs, traction devices, slings and braces. The closure is part of Zimmer’s “global restructuring and transformation initiatives” that were unveiled in January this year. The Statesville site closure is part of this strategy that aims to save over US$100 million for the company, which looks set to lose its title of world’s largest orthopaedic company to DePuy by the end of the year. The company has also said it will be “reducing management layers and consolidating global sourcing to drive vendor cost reduction”. This could well mean that in the near future, Zimmer could be axing non-essential executive positions from its Warsaw headquarters, and perhaps even terminating deals it has with component suppliers and distributors, as it strives to save that US$100 million.

thank you to Sophie Bracken, editor of Orthopaedics Business News for providing this article.



Espicom Business Intelligence

Will Axis-Shield give into rising pressure of takeover offer from Alere?

The Medical Technology Blog

Alere, a key player in the rapid point-of-care and laboratory diagnostics market with products that focus on infectious disease, cardiology, oncology, drug abuse and women’s health, has brushed aside negative feedback from Axis-Shield and pushed ahead with a cash offer for the UK-based company.

As part of the offer, Axis-Shield’s shareholders will be offered £4.60 (or approximately US$7.51) for each Axis-Shield share held by them, valuing the transaction at approximately £230 million (or approximately US$375 million). The offer will be conditional upon Alere receiving valid acceptances in respect of not less than 90 per cent of Axis-Shield shares to which the offer relates and not less than 90 per cent of the voting rights carried by those shares.

In June, Alere had made an indicative non-binding proposal to acquire Axis-Shield, however, the latter rejected the proposal and also turned down an offer to conduct further discussions with Alere. At the time, Alere revealed that it was keen to work towards a recommended takeover offer for Axis-Shield and that it would welcome the opportunity to discuss a possible transaction in a constructive manner. The company said its proposal was “a means to facilitate discussions” with Axis-Shield and its shareholders. Now, in a move that adds further pressure on its target, Alere has made an additional open market purchase of approximately 6.4 per cent of Axis-Shield’s share capital.

Axis-Shield is an international in vitro diagnostics company, headquartered in Dundee, UK, with R&D and manufacturing bases in Dundee and Oslo. The group specialises in the supply of instruments and tests for the rapidly growing physician’s office testing market and the development, manufacture and marketing of diagnostic kits in areas of clinical need, including cardiovascular and neurological diseases, rheumatoid arthritis, and diabetes. During 2010, the company made significant advances with the continued growth of its international in vitro diagnostics business and revenues exceeded £100 million for the first time.

Alere believes it’s all cash offer is highly attractive for Axis-Shield shareholders, representing a ‘compelling value proposition’ with a high degree of certainty at a substantial premium to the undisturbed share price. In addition, the company expects Axis-Shield will be complementary to its existing businesses and that it can help develop and grow the Axis-Shield product portfolio to be a clear leader worldwide in its core markets.

Over the forthcoming weeks, the question remains as to whether Axis-Shield will succumb to the pressure to reach an agreement Alere, and whether the latter, with revenues of over US$2.1 billion behind it for 2010, has done enough to win over the UK-based company.



Espicom Business Intelligence

The Increasing Scope of Lawyers in Healthcare

The Medical Technology Blog

In the third instalment of her guest blog, Louise Campbell, an undergraduate law student with the University of Southampton, examines the increasing scope of lawyers in healthcare

Nowadays, law firms have become as important partners to the medical industry as the scientists, sales executives, marketing managers and CEOs that are driving the company forwards.  This blog looks at some of these areas in more detail and illustrates that lawyers are as important in the work environment as are in the courtroom.

Commercial Agreements

Lawyers are often employed to aid the creation of commercial agreements between companies. They will assist in negotiating the terms of the contract and, once agreed, will draft and facilitate the signing and exchange of the relevant documents and contracts. The nature of the terms and of the agreement will naturally vary, but some of the most common used in the healthcare industry include:

  • Patent Licence agreements: key terms may include: the scope of the licence, its exclusivity and the territory it covers the licence, which often includes or excludes all countries that have granted patent protection to the invention. Others encompass remuneration, royalties and how such payment(s) are made; and duration, how long the agreement is to last
  • R&D collaboration: where two or more enterprises agree to collaborate developing new products or processes. To commercialise the results of the collaboration, the agreement often extends to the exploitation of the results. Collaboration can also extend to higher education institutions
  • Confidentiality agreements
  • Contract manufacture and supply agreements:  As a guide, key terms may include: interpretation; orders for products; manufacturer obligations; inspection and testing; delivery; rejection of products; warranty and indemnity; prices and payment;  how to vary the terms of the contract in the future if necessary; intellectual property;  confidentiality and; termination
  • Distribution and agency agreements: An Agency Agreement involves appointing a third party to act on its behalf, marketing and selling its products and services – often in exchange for commission. The distribution agreement transfers the ownership of goods to the distributor prior to their ultimate sale. Flexibility in such agreements allows for sales targets and territories to be negotiated
  • Co-marketing and co-promotion agreements: Co-marketing is where two companies cooperate with separate distribution channels. This sometimes includes profit sharing. Co-promotion on the other hand, is where two or more companies use each other’s salesforces as well as their own, to promote the same brand or range of brands

Corporate Services

Corporate compliance, in other words, meeting statutory obligations surrounding how a company operate, reporting and particularly directors’ duties towards shareholders are covered by legislation. Companies are regarded as legal persons and failure to meet the various requirements may result in fines and other punishments for directors and officers.
In the UK, the most recent updating of legislation governance is The Companies Act 2006 which supersedes previous regulations. It is the longest Act of Parliament in British history, containing 1,300 schedules in 15 sections. Given the considerable size of the legislation, lawyers are useful in determining which sections are relevant to the company and advising as appropriate.

Lawyers may also provide useful guidance in raising funds and the most suitable process in which to do this. Some examples of common practices are raising money through debt financing or equity financing. Debt financing is when a firm raises money for working capital or capital expenditures by selling bonds, bills, or notes to individual and/or institutional investors. In return for lending the money, the individuals or institutions become creditors and receive a promise that the principal and interest on the debt will be repaid. Equity financing is where shares are issued in a public offering. In return for the money paid, shareholders receive ownership interests in the corporation.  A recent example of this in action is Archimedes Pharma successfully raising £65 million round of new funding in 2010. That particular deal is believed to be Europe’s biggest single fund raising round for a bio-pharma company in 15 years.

Should a company wish to merge or acquire another company, a legal mergers and acquisitions team ensures that this is completed effectively. Lawyers are heavily involved in the due diligence side of this, analysing the target firm’s business history, its assets, its capital, and its organisational structure.  They will also negotiate, draft and facilitate the signing of contracts and help manage the integration process after the merger or acquisition is complete.

Intellectual Property and due diligence

Protecting and defending innovations in this sector is essential. Companies may call upon lawyers for help with applying for intellectual property rights, such as patents and trademarks, and perhaps identifying a particular strategy with regards to this.

Due diligence is a routine practice in the healthcare sector prior to investments and public offerings, mergers and acquisitions, private equity and venture capital transactions. These transactions involve providing capital to private businesses to speed up their development. The completion of a successful venture capital or private equity deal requires the deal to progress through a multistage process including due diligence. Due diligence is also a key element in licensing and collaboration agreements.

Dispute Resolution

For when it all goes wrong, lawyers are often the first port of call for resolving a dispute either through going to court or an out of court arbitration or mediation process.

In terms of IP disputes, often these centre on enforcement and/or infringement of IP rights and disputes over ownership. A recent example of this was the patent dispute between Ranbaxy (UK) Ltd and AstraZeneca AB in which Ranbaxy, the claimant, successfully achieved declaration of non-infringement and revocation of a European patent owned by AstraZeneca, the defendant pharmaceutical company.

For contract disputes, the most cost effective way of settling the disagreement is through out of court means as litigation costs can be huge.

Product liability is key area for disputes. Lawyers can be on hand to aid defence or settlement of product liability claims. Strategic advice and representation in multi-claimant litigation is also offered by many law firms as well as assistance with international coordination of product liability actions. They may also advise on what steps to take after realising any safety concerns or objections raised by regulatory authorities such as product recalls, additional safety instructions or temporary restrictions on use. The unmissable DePuy ASR hip replacement litigation is a prime example of this.

Regulatory and Competition compliance

The healthcare industry has been increasingly subject to regulatory and competition (antitrust) measures, including regulation of clinical trials, freedom of information and advertising.  Lawyers are often asked to take the hassle out of contacting the relevant regulatory authorities and advise on ensuring compliance with these regulations.

With regards to competition law, ultimately companies must not abuse their dominant market position should they be in such a position of strength. Co-marketing and promotion agreements, as an example, can be subject to intense scrutiny by the national and European competition authorities as can any mergers and acquisitions. Lawyers can help set up a compliance programme or advise on how to minimise and reduce any risk of violating competition laws. One example of this was when AstraZeneca lost a claim that false representations to the European Patent Office constituted an abuse of their dominant market position.

Infrastructure, Tax and Employment

Tax lawyers are useful in ensuring that the corporation is tax efficient and drafting documentation to allocate tax risks between parties in the agreed manner.

Lawyers are also involved in the transactions for the design, construction and maintenance of new and existing healthcare infrastructure.

Employment lawyers can aid in drafting employment contracts, tailored to the needs of the business, and consultancy agreements which strike the right balance between safeguarding your interests and commercial and economic flexibility. In some cases, healthcare corporations will need to place restrictive covenants on their employees to prevent them from exposing confidential information or intellectual property and lawyers can advise on the best ways to do this also.



Espicom Business Intelligence
 Page 1 of 3  1  2  3 »

Web Hosting by HostGator