Originally published March 2005

The last year saw a number of adverse legal changes for the innovative life sciences industry in Europe. This article looks at a number of these recent changes and asks whether the news really is all bad.

A new European pharmaceutical regulatory regime came into being in April 2004¹. This legislation revises the procedure prescribed for gaining regulatory approval for a medicinal product. One of the key changes was the amendments made to the approval route for generic medicines.

The current legislation allows a generic manufacturer to rely on the innovator's data for the originally authorised product (a "reference product") to establish the safety and efficacy of his "essentially similar" product, but only after the originator of the reference product data has enjoyed a period of "data exclusivity"....

This service is completely FREE but for the full article and thousands of other articles from 100+ countries please tell us about yourself by registering (and yes, our lawyers like to think you've read our Disclaimer). All Fields marked with * are required. Registered Before?   Email*: We need to have a valid email address, as we send your registration confirmation link to this address. For information about your privacy rights, please read our privacy statement (link below).   Password*: More than 2 characters and less than 20, case insensitive Confirm Password: Title*: Forename*: Surname*: Select Title Mr Mrs Miss Ms Dr. Prof. Esq Sir Company Name*: Position*: No Position Selected Inhouse Counsel, Lawyer in Company/Government CFO/FD, Inhouse Accountant, Treasurer Lawyer in Law Firm, Private Practice, Barrister Consultant, Accountant in Accountancy Firm, Practicing Accountant Banker, Stockbroker, Analyst, Economist CEO, Owner, Chairman, President, Mng Director Director, Vice President, Senior Company Executive Marketing, Sales, Business Development Editor/Journalist, Librarian, Researcher IS/IT Student, Academic, Graduate Please select your position, or one that closely matches your jobrole. Industry Sector*: Not Selected Accounting & Consultancy Advertising & Public Relations Aerospace & Defence Automotive Banking & Credit Basic Industries Business & Consumer Services Chemicals Consumer Industries Environment and Waste Management Financial Services & Insurance Healthcare IT Law Firm Media & Internet Metals & Mining Oil & Gas Pharmaceuticals & BioTech Property Retail & Leisure Securities & Investment Telecommunications Transport Utilities Education Government Engineering/Construction Please select your Industry Sector, or one that closely matches. Country*: --Select a CountryUnited StatesUnited Kingdom--Afghanistan Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia bosnia herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territories British Virgin Islands Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Cook Islands Costa Rica Cote D'ivoire Croatia Cuba Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic East Timor Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories FYR – Macedonia FYROM Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island And Mcdonald Islands Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Isle of Sark Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Kosovo Kuwait Kyrgyzstan Labuan Lao Peoples Democratic Republic Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macau Macedonia Madagascar Madeira Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands Netherlands Antilles Nevis New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island North Korea Northern Mariana Islands Norway Oman Pakistan Palau Palestinian National Authority Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Reunion Romania Russian Federation Rwanda Saint Helena Saint Kitts Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and Sandwich Islands South Korea Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States United States Minor Outlying Islands Uruguay Uzbekistan Vanuatu Vatican City State Venezuela Vietnam Virgin Islands (U.S.) Wallis And Futuna Islands Western Sahara Yemen Yugoslavia Zaire Zambia Zimbabwe Preferred Start Page: Please SelectAccounting Anti-trust/Competition Consultancy Services Consumer, Health and Family Corporate/Company Law Criminal Law Energy & Natural Resources Environment Finance and Banking Government & Public Sector Immigration Information Technology and Telecoms Insurance Intellectual Property International Law Labour and Employment Litigation, Mediation & Arbitration Media & Entertainment Offshore Pharmaceutical, Healthcare & Life Sciences Real Estate & Construction Tax Transport Please SelectAll Regions Asia Pacific Australia Canada Europe Latin America Middle East & Africa Offshore UK USA Your preferred homepage is already pre-selected according to the Topic and Region of this article you are currently viewing. Setting the topic and region this way, will ensure when next you log in your get the most relavent content that relates to you. Click here to read our privacy statement Check to state you have read our Terms and Conditions Terms & Conditions and Privacy Statement Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason. Use of www.mondaq.com You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products. Disclaimer Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server. The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time. Registration Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes: To allow you to personalize the Mondaq websites you are visiting. To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website. To produce demographic feedback for our information providers who provide information free for your use. Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services. If you do not want us to provide your name and email address you may opt out by clicking here . If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here . Information Collection and Use We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users. We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading Mondaq News Alerts In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas. Cookies A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site. Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so. Log Files We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information. Links This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site. Surveys & Contests From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site. Mail-A-Friend If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database. Security This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com. Correcting/Updating Personal Information If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com. Notification of Changes If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected. How to contact Mondaq You can contact us with comments or queries at enquiries@mondaq.com. If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

Specific Questions relating to this article should be addressed directly to the author.

Do you have a question for the author?

Other Information about Lovells

View summary of all information contributed by Lovells

View Popular Related Articles on from Europe

Use Of Unlicensed Medicines - Legal And Ethical Issues (Bircham Dyson Bell LLP)

In the current climate of austerity, healthcare providers may be seeking ways to contain costs of treatment.

Competition And Consternation In The Private Healthcare Market (Bircham Dyson Bell LLP)

The end of 2011 was marked for the private healthcare market by the Office of Fair Trading's announcement of its provisional decision to refer the sector to the Competition Commission (CC) for investigation, and by public signs of tension between Bupa and BMI, the biggest private medical insurer and the largest private hospital chain respectively.

Novelty Destroying Acts In Clinical Trials (Axon Lawyers)

A recently published decision of the European Patent Office’s (EPO) Board of Appeal about European patents and clinical trials provides for interesting reading and for some important pointers about how to deal with clinical trials for medicinal products but also for medical devices as to not destroy novelty of a patentable invention with invalidity as result.

Death At The Dentist (Charles Russell LLP)

Recently a patient died after suffering from an allergic reaction to Chlorhexidine. David Reissner discusses this issue and provides some recommendations.

Pharmaceutical License Registration Dossiers In Turkey: Confidential In Entirety? (Çelen Law Office)

The Turkish Ministry of Health is obliged to keep the content of the license registration dossiers confidential under Article 28 of the Turkish License Regulation and article 39 of TRIPS.

New Regulation On Promotional Activities Of Medicinal Products For Human Use (Mehmet Gun & Partners.)

The long awaited Regulation on Promotional Activities of Medicinal Products for Human Use (New Regulation) is eventually published in the Official Gazette dated August 26, 2011.

Special Regulation Pertaining To Medical Device Clinical Researches In Turkey (Mehmet Gun & Partners.)

While debates related to clinical research and its legal foundations within Turkey continues, a special regulation has been issued pertaining to Medical Device clinical research.

New Limits On Pharmaceutical Samples (CMS Cameron McKenna LLP)

From 1 January 2012, doctors will only be able to obtain a medicinal product sample for 2 years after first requesting it, and will be limited to a maximum of 4 samples per year.