Bibiana Campos-Seijo is a former editor of Pharmaceutical Technology Europe.

Bibiana Campos-Seijo

Counterfeiting has become the topic of conversation at all levels of the pharmaceutical industry. Considering the rising number of cases, this is hardly surprising.

The good news is that with mounting concerns from industry bosses comes pressure for EU regulators to take tougher action. Consequently, the European Commission (EC) has decided to finally sit down and write up draft legislation that will regulate the imports of APIs into Europe, curbing substandard APIs. Here, however, we are dealing with two issues at the same time: imported drug products and substandard products.

With regard to imported products, EU legislation obliges EU drug manufacturers to use APIs prepared according to GMP standards, regardless of their country of origin. However, while EU plants are subjected to regular inspections, audits are rarely conducted in sites outside the EU. Therefore, Chinese and Indian manufacturers are exporting APIs, which they claim to be GMP compliant, into Europe without their sites, systems and processes ever being under scrutiny. It is only fair that the EC, at risk of stretching its resources, has promised to conduct more audits in foreign API manufacturing plants to validate their claims.

When it comes to substandard products I have a bit of a problem. While it is obvious that counterfeit legislation should apply to APIs as well as the final product (this has traditionally been the approach of regulatory authorities), the EC is looking to take this a step further by recognizing that substandard manufacturing is a form of counterfeiting too. I think that while we should all agree that counterfeit and substandard products are potentially very dangerous (and in most cases illegal!), they should not be put in the same bag. According to the dictionary, a counterfeit can be defined as "an imitation designed to deceive or defraud"; in contrast, substandard is used to describe the "failure to meet an established or required standard". But this is not only a matter of semantics. My argument is that while counterfeit products are quite likely to be of substandard quality, substandard products are not necessarily counterfeits. The difference is the purpose or intent.

An example of this is the much talked about heparin case, where contaminated heparin was traced back to deficient (substandard?) intermediates in the early stages of production. If you are hoping to establish a trading relationship of some sort, it is very foolish (and irresponsible) to knowingly supply substandard products to a Western buyer that is very likely to discover any deficiencies. It is business suicide! My impression of the story is that the product supplied was simply substandard rather than counterfeit, as the intention of the supplier was not to defraud the buyer. Am I being naïve?

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Articles

Business suicide?

It's back to school. Another summer has flown past and here we all meet again, ready to return to work and face the winter with renewed energies. Welcome back!    

While some of you have been enjoying a well-deserved break during July and August, at Pharmaceutical Technology Europe (PTE) we have continued to work hard, not only to bring you the most up-to-date information regarding the European pharmaceutical and biopharmaceutical industries, but to do so in an exciting, innovative and comprehensive way. This effort has resulted in the creation of new sections, and the implementation of a series of developments and improvements in the PTE magazine and website. We are confident you will enjoy them.  

So, what's new? In the PTE magazine we have introduced a brand new section where we'll be tackling strategic business and marketing issues, corporate policy, legislation, finance and much more through interviews, industry reports and opinion articles. This section will be called Business Focus and can be found in pages 85–98. 

Additionally, as CPhI/ICSE and Technopharm/PowTech are taking place at the end of the month in Germany, we have dedicated some space in the September issue to preview these events, present the profiles of a number of exhibiting companies and showcase some of the products that will be displayed at the show.   

) we have several exciting new developments. Out and About is a new section where the members of the editorial team write their personal impressions of events, trades fairs and congresses, and of visits to manufacturing plants and R&D facilities. From a review of Excipient Fest Europe 2008 to a visit to Almirall in Spain, you can find it at 

In the Online Exclusives section in our homepage, you will find a series of quick interviews with key members of the pharmaceutical and biopharmaceutical industries, together with additional feature articles and reviews for quick access and reference. Lluis Ribas de Pouplana (Omnia Molecular) and Fraser Black (SAS GE Healthcare) have been two of our 'victims' so far. You can find this section at 

And last but not least, we have created two new sections to host Case Studies and White Papers. If your company would like to see its case studies and white papers featured on our website, please do not hesitate to get in touch.   

In summary, this is a September issue packed to the brim with feature articles, interviews, insights and opinions... Enjoy it! Also, if you are going to CPhI, please come and visit us at Hall 3.1 Stand 31H19. See you in Frankfurt! 

It's back to school. Another summer has flown past and here we all meet again, ready to return to work and face the winter with renewed energies. Welcome back!

Back to school

As summer approaches, the European pharmaceutical industry is preparing for a well-deserved break. However, some will leave the arena on a higher note than others. While big pharma is embracing the globalization of the industry and suffering under extreme pressure to improve performance, the biopharmaceutical sector retires with a smile and reasons to celebrate.

On a national level, the UK's contribution to biotechnology and, in particular, stem cell research has been outstanding. Interestingly, this has nothing to do with new technologies or discoveries, but with groundbreaking changes in regulation. In what became an overwhelming victory (336 versus 176 votes) on 19 May, the House of Commons voted in favour of the use of interspecies hybrid embryos for stem cell research.  

Although this is a controversial move, the government hopes it will provide researchers and scientists with the legal framework they require to achieve a better understanding of disease processes, and pursue new cures and treatments. When asked, the UK's Prime Minister, Gordon Brown, said: "the question is not whether they [hybrid embryos] should exist, but how their use should be controlled." 

On a European level there has been a landmark development: the European Parliament launch of the European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI). This initiative aims to create a European bank or collection of samples of biological human material including blood, tissue, DNA, proteins and other genetic material. This project will also protect the data from inappropriate use by harmonizing national legislations and guarantee the quality of the samples by establishing common standards for collection and storage. 

At Pharmaceutical Technology Europe, we are looking forward to the summer too! By the time this issue goes out we'll be working hard on the publication of our Buyers' Guide, an essential directory that places your products and services in front of the industry's key buyers, and on the development of a new management section that will see the light in our September issue.  

Summer is coming!

On 7–9 May I attended ERBI's Biopartnering Exchange in Cambridge (UK), an event that brought together national and international entrepreneurs, senior executives and industry experts of the biotechnology sector. 

As 2008 was ERBI's 10th anniversary they really pushed the boat out: we enjoyed talks by Nobel Prize winners, Professors and one or two Sirs, and were treated to a fabulous firework display.  

From where I was sitting, the meeting was hugely successful: the sessions were interesting, informative and entertaining, and the hectic biopartnering schedule saw many delegates trying to fulfil their extremely busy timetables yet maximize the quality of the time spent meeting potential clients and investors. 

A very insightful session was chaired by Andy Richards, who invited four key players in the industry to discuss their experiences and reminisce about the good, the bad and the sometimes ugly days that have helped shape their careers. It was also very refreshing to hear Clive Cookson, Science Editor of the 

, encouraging researchers and scientists to engage with the press and talk to journalists. Simultaneously, he called for the media to focus on the relevance of the information provided and not its entertainment value when reporting scientific developments.  

And there was debate too! There seemed to be strong disagreement among the different experts with regard to funding availability (i.e., venture capitalists or VCs) and the future of the biotechnology sector. While some asserted that there are no funds and many small companies, unviable in their view, should disappear, others maintained that although a proportion of VCs appear to have vanished into thin air, there is still money, room for investment and will to aid start-up private companies. However controversial this may be, it is a sign that all parties (industry, academics, investors) are still passionately trying to steer any developments in the biotechnology sector in the right direction. 

But my favourite moment of the event has to be Professor Sir Christopher Evan's presentation. Among many incisive comments, whacky slides and clever quotes, the concluding statement "I'd rather be a tiger for one day than a sheep for 100" was the icing on the cake. It is a very romantic notion indeed, but one that, I fear, remains quite invalid as a business model. It makes, however, for wonderful life ethics... 

On 7–9 May I attended ERBI's Biopartnering Exchange in Cambridge (UK), an event that brought together national and international entrepreneurs, senior executives and industry experts of the biotechnology sector.

A tiger for a day!

One of the headlines before going to print was 'Pfizer earnings suffer as patent expiries cause damage'. This US pharma giant has reported a net income decline of 18% for the first quarter, despite the positive impact of the favourable currency rates. 

Although some of its products continue to generate handsome profits, Pfizer is planning to do what one would expect it to: cut costs. As patents continue to expire for other big companies, this is a scenario we can expect to encounter again in the coming months. 

It's bad news for some workers of the sector, as the company's immediate plans involve the sale or closure of 13 manufacturing plants and the decommissioning of four R&D facilities. Jobs will be lost. How could this possibly be a positive outcome? Well, I guess it is all a matter of perspective... 

It is certainly a positive outcome for a number of CROs and CMOs as the scaling down of big pharma's manufacturing and research capacity is likely to boost their growth. In fact, the big companies are able to 'take the hit' as the opportunity to - outsource, and thus reduce production costs and improve margins, exists. Additionally, the sale of facilities directly benefits other pharmaceutical companies wishing to expand and grow, which, in turn, means more jobs. 

And from the perspective of consumers on a global scale? Another positive outcome: prices of medicines are likely to fall, with patients favouring the less expensive generics. Interestingly, it has been reported that, for the first time in 5 years, insured US consumers have paid less on average for their prescription drugs. In summary, as consumers, we benefit from lower prices, greater availability and, in the long term, better treatment. 

So let's be positive: while patent expiries mean pharma will cut costs (and jobs!), consumers are likely to benefit from better, cheaper treatments. And for us? Well, jobs will come and go as the pharmaceutical companies change, develop and adapt, but the industry is healthy and we are confident that the balance will be restored. 

One of the headlines before going to print was 'Pfizer earnings suffer as patent expiries cause damage'. This US pharma giant has reported a net income decline of 18% for the first quarter, despite the positive impact of the favourable currency rates.

A matter of perspective

It is the end of an era. Building on more than 6 years of dedication and hard work, Gurminder Marwaha has left 

 (PTE) in search of new challenges. As his successor, I would like to join all the members of the editorial team in wishing him every success.  

And so it is time for change. As the first Spaniard and the first woman to become the Editor of PTE, it is indeed a privilege to be writing this editorial and to assume the editorship of an already successful publication, leader in its sector, and which continues to grow steadily and healthily in readership.  

I am honoured to be the new Editor of this magazine, especially at such an exciting time. During 2008, PTE will be celebrating its 20th Anniversary, an event that will be commemorated monthly with special features articles that evaluate the last two decades of developments in the pharmaceutical industry. 

   And with change come fresh ideas and new initiatives and plans, some of which you will see already implemented in this issue or gradually coming into being in forthcoming editions of the magazine. Indeed, in this issue of PTE we are introducing, for the first time, a biopharmaceutical section to reflect the rapid growth and development observed in this field of the pharmaceutical industry. Additionally (and for this issue only!), we are including a section specifically dedicated to Interpack, the largest international trade fair for the packaging industry worldwide, an event that will take place in Germany at the end of this month.  

Finally, I would like to thank you, all pharmaceutical technologists across Europe, for your continued support of PTE through the years. It is your support and your contributions that make it the successful magazine that it is. With your input, I look forward to an even brighter future. 

It is the end of an era. Building on more than 6 years of dedication and hard work, Gurminder Marwaha has left Pharmaceutical Technology Europe (PTE) in search of new challenges. As his successor, I would like to join all the members of the editorial team in wishing him every success.