European Union: SPC MW – A New Privilege For Generics Producers?

Last Updated: 2 April 2019
Article by Iwona Płodzich-Hennig

The pharmaceutical industry is divided into two categories of manufacturers: original drug companies and generics companies.

Original drug manufacturers are usually those who first look for new molecular targets that could be the target for completely new drugs and then, over the course of laborious and expensive research and development, create new preparations and formulations in order to verify the efficacy of the product in clinical trials, and finally register the new drug.

On the other hand, generics pharmaceutical manufacturers shorten the research and development process to include only a stage for developing alternative formulations or recreating the composition of original drugs based on the results of the research conducted by the original manufacturer.

However, today more and more generics companies are developing so-called improved generics, i.e. products that not only replicate known original drugs, but also offer added value in the form of, for example, improved bioavailability, reduced side effects or a more convenient form of administration.

Although the boundaries of the traditional division into original/branded medicines and generic medicines1 are becoming increasingly blurred, manufacturers of original medicines benefit from legal safeguards that compensate them for the research and development costs they incur.

Shortening the development path for generic products therefore comes at a price, as original companies benefit from additional protection regulated by pharmaceutical law. For pharmaceuticals authorised under the centralised procedure, this is known as the 8+2+1 formula, where the results of clinical trials are not made available for 8 years (data exclusivity), then there is a 2-year period where the company enjoys market exclusivity and finally, if they are able to register the drug for a new indication, an additional year of protection can be gained. Therefore, the development of generic alternatives to the original medicine is delayed.

In addition, manufacturers of original medicines benefit from patent protection for their products, thus enabling them to achieve a monopoly for 20 years in the market where the patent is in force.

The mechanism by which the exclusive use of a patented drug can be extended is called the Supplementary Protection Certificate (SPC). SPC grants a right to extend patent protection for products that were the subject of the first marketing authorisation. Pursuant to EU regulations No. 469/2009 of 6 May 2009 and 1768/92, uniform regulations concerning SPCs were introduced, which allow an additional period of protection of a maximum of 5 years to be obtained for original products.

However, current changes taking place within the pharmaceutical market, in particular the strengthening market position of Asian companies, threaten to weaken the competitiveness of European manufacturers.

During the period of patent or SPC protection, but after the expiry of data protection, generics companies can only carry out the necessary research and development work that would have enabled them to develop their own generic medicine and carry out the registration process.

Under the current legal framework, a generics company can only start the production process of its medicine once the SPC expires. As we know, the production of medicines requires considerable preparatory work, including the purchasing of raw materials and optimisation and validation of the manufacturing process, which means that original companies in effect enjoy an additional monopolistic period of at least a few months before generic drug manufacturers can deliver their medicines to pharmacies.

In addition, the high costs of modern therapies often result in a significant reduction in their use and thus in their accessibility for patients. Because of these factors, the European Commission has begun to consider whether the current patent protection system in relation to SPCs should be modified.

Now, following an in-depth analysis of the market situation and the impact of regulation on this state of affairs, the European Commission has proposed a new "privilege" for generic drug manufacturers, the so-called SPC Manufacturing Waiver (SPC MW).2

The aim of this regulation is to enable manufacturers to start production of generic medicines during the SPC period. However, these generic formulations can only be sold where SPC protection is not in place (for example, to non-EU countries). Such a "privilege" would allow generic medicines to be placed on the European market on the very first day after the expiry of SPC protection.3 The proposed relaxation of SPC protection is expected to improve the situation of generic companies and allow patients faster access to cheaper generic equivalents, thus giving them the opportunity to benefit earlier from the latest medicines.

The draft amendment4 to Regulation 469/2009 on SPCs sets out a list of derogations for the protection of medicinal products covered by the SPCs. This includes, inter alia, activities such as:

  • the manufacturing of a protected SPC product or a medicinal product containing that product for the purpose of export to third countries;
  • any related activities which are strictly necessary for manufacturing within the EU such products for export (for example, importing an active substance or excipients, manufacturing, packaging or temporary storage);
  • manufacturing, no earlier than 6 months before the expiry of the SPC, a medicinal product covered by the SPC for storage until the expiry of the SPC to enable it to be sold after the expiry of the certificate; or
  • carrying out, no earlier than 6 months before the expiry of the SPC, any related activities which are strictly necessary to manufacture the medicinal product for that purpose.

In addition to the benefits conferred by the SPC MW, a number of obligations for generics manufacturers have also been introduced in draft amendment 469/2009 for the sake of clarity and in order to eliminate possible abuses. Among other things, it is proposed that both the national medicine regulatory authority in the country where the SPC is in force and the SPC holder itself should be informed of the intention to manufacture the product during the SPC period no later than 3 months in advance, and that the product should be properly labelled as being for export5 in order to prevent repackaging or counterfeiting.

As outlined in a study commissioned by the European Commission and chaired by Charles River Associates,6 changes to the SPC regulation could bring enormous benefits to the European pharmaceutical market, such as:

  • 9.5 trillion additional net sales
  • 25,000 additional jobs
  • 3.1 trillion euros of savings for the European health system.

Unfortunately, generics manufacturers and patients will have to wait for any changes resulting from the SPC MW "privilege" to take effect.

It is assumed that the SPC MW will not apply to medicines currently protected by the SPC, while for medicines for which an SPC has been applied before the approval of the amendments to the regulation and for which an SPC will be granted after the introduction of the SPC MW, the adopted time limit is 1 July 2022, or 3 years from the date of entry into force of the amended regulation.

The draft amendments to Regulation 469/2009 are currently pending approval by the European Parliament.


1. In this article the concept of generic medicines also covers biosimilar medicines.


3. ibid, infographic: "The Impact of the SPC Manufacturing Waiver on Jobs, Competitiveness & Patient Access to Medicines".


5. Annex I of the draft amendment to Regulation 469/2009, draft logo to be affixed to products intended for export.


The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions