In my view

Written by Arjan Menger on 21 September 2022. Posted in In my view.

Mexican border issue

About 15 years ago that the owner of one of the manufacturers of plasma derived medicinal products wrote me a letter and asked me to personally close the plasma collection centers along the Mexican border in the USA. Mexican citizens who were in the possession of an US issued Visa, were able to cross the border and donate their plasma and received a compensation for it. The reasons for the letter were not very clear since that company had no centers in that area. A copy of that letter was sent to the regulatory authority FDA and several patient organizations. Obviously, they raised questions that I had to answer.

I did not have the authority to make such a decision, but more importantly I wanted to have a good understanding of the practices in these centers before arriving at any conclusion. I decided to do a few things:

Personally visit and observe the plasma collection in some centers
Require an extra audit by an independent auditor to verify that correct procedures were followed
All companies collecting plasma had one center audited and had no input on the decision about what center was going to be audited

The results were excellent. All Mexican donors had the required Visa, were very committed, came back on a regular basis, had good health records and the donated plasma was of very high quality.
This was communicated to the FDA and the patient organizations, and the issue was over.

In 2021, the US Customs and Border Protection Agency (CBP), amid the COVID pandemic, decided to block the entry of Mexican individuals into the USA when their purpose was to donate plasma. CBP considered as “labor for hire” and therefore the compensation for the donations (in their opinion) violated the rules of the Visa. That decision caused a further reduction of collected plasma, beyond the reductions because of COVID. Needless to say, that many were very concerned by this unexpected and unilateral action of CBP.

A lawsuit was filed by the manufacturers who had collection centers along the border to challenge this decision. On September 19, 2022, a judge in the Federal District Court of the District of Columbia issued a preliminary injunction that bars CBP from enforcing its policy of barring Mexican nationals from crossing the border to donate plasma in the U.S. until the case is litigated on its merits. It is impossible to say what the final outcome will be, but normally a decision like this is a reliable predictor for the final decision.

This is an enormous success for the affected companies (such as CSL Behring and Grifols) who were challenging the CBP decision. Also, PPTA supported that case with several statements and provided calculations about the impact on the volume of US plasma collection because of that decision.

Since I retired from my position as President & CEO of PPTA, I have refrained from making comments about the activities of the organization or its members. I have given my best to help this industry to get to the place where they are today. Others have taken over that responsibility and I have given them all the freedom to ensure that patients have access to the many plasma derived medicinal products they clinically need. Fighting this irresponsible CBP decision is one of the things that needed to be done. PPTA had a very competent legal officer that was able to do that. I recruited him many years ago and he has never disappointed me or the companies with the quality of his work. One of the companies that benefits from this legal outcome is CSL Behring.

It is very unfortunate that this company decided to leave PPTA as of 2023. Until the moment of writing this column I have not heard what the reasons are. What I know is that this decision was communicated by the CSL Behring representative on the Board. She gave up her role as Chairman and soon after that she went into retirement. PPTA had no other choice than to make personnel cuts because of the budgetary consequences. One of the persons affected was the legal officer that helped this case. I am always uncomfortable when people are losing their position when they did nothing wrong.

Jan M Bult

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Written by Arjan Menger on 07 March 2022. Posted in In my view.

Ukraine

For a little over 2 years, I am advising Biopharma Plasma, a company in Ukraine. The company has built a state if the art fractionation plant in Bila Tserkva, approximately 70 kilometers away from the capital Kyiv. In addition, the company has built a network of plasma collection centers and is demonstrating that it is possible to build a successful company if you have commitment and resources,

Because of this activity I have been able to travel to Ukraine around 10 times and have learned a lot about the country and its population. I normally stay in the same hotel that CNN is using when they report from Kyiv. You can see the square with the golden domes of a very important orthodox church. The church is surrounded with a wall that has pictures of fallen Ukrainian soldiers.

I have met multiple hard-working professionals who are interested to support their country with the quality therapies that they are able to produce. These therapies go to patients in a part of the world that are insufficiently supplied by the bigger companies for multiple reasons that I do not go into today.

I want to express my deepest support for the population of Ukraine who are now suffering because of the desire of a despot who wants to undo several decades of history.

At the same tIme, I am disgusted by the lack of real support from the world. I have seen a row of government leaders coming to express their support for Ukraine. However, it is only words and no deeds. The Ukrainian people is in their own when it comes to actual fighting. Yes, I understand the Rules of Engagement of NATO but I also understand that talking about not putting troops on the ground, was an open invitation to Putin to go ahead.

It is not only NATO that has its principles. Have we forgotten the enormous discussion in Europe about Ukraine being allowed to enter into the European Union? I am convinced that the situation would have been different if Ukraine had become a member.

Now we must witness the desperation of families being split, women and children leaving the country to go to Europe while their husbands stay behind to defend and help the country. Most disturbing is that already many innocent people have lost their lives.

The Biopharma Executives are working to produce albumin that is supplied to the Red Cross for wounded soldiers.

AND WE SIT IN FRONT OF THE TELEVISION AND WATCH IT WHILE IT HAPPENS BEFORE OUR EYES.

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Written by Arjan Menger on 23 November 2021. Posted in In my view.

Otto Schwarz Award

It is a while ago that I wrote a column and it time to start again.

Last week I received the prestigious Otto Schwarz Award from the Plasma Protein Therapeutics Association (PPTA). This Award is given to individuals that have shown leadership in the plasma protein industry. Many times I was able to present this award to winners and now I was the recipient. It is a strange but pleasant feeling.

Dr. Otto Schwarz was the co-founder of Immuno AG And one of the founders of what is now called PPTA. A gentleman of high integrity and a visionary of his time. I was very fortunate to know him personally and never forget my visit to him and his wife in Vienna in April 2012, 2 months before he passed away. He was very pleased with the visit and both he and his wife were nicely dressed for this occasion. We had lunch together in their home that was full of selected artwork.

I have known all the previous recipients personally and am very honored to be part of that elite group that include Knut Hansen, Jack Ryan, Steve Petteway, Reinhard Burger, Herbert Dichtelmueller, Larry Guiheen, Thomas Kreil, Hans Peter Schwarz, Shinji Wada and Paolo Marcucci.

In my next columns I will write more about some of the accomplishments of the previous winners.

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Written by Arjan Menger on 04 December 2020. Posted in In my view.

Human milk regulation

This time I want to focus on a side of our society where there is a lot of suffering by innocent people that is not commonly known. I am talking about babies who are born premature. A normal pregnancy lasts about 40 weeks from the date of the last menstruation cycle. Every year in Europe there are about 500,000 children born before week 37 and 100,000 will have to go to Intensive Care.

Of these 100,000 pre-term babies, 10% will die in the first weeks after birth, 10% develop serious disabilities, 40% develop some problems and about 40% have no problems at all. Some of these pre-term infants have become very well known, such as Winston Churchill, Albert Einstein, and Napoleon.

The one thing that these pre-term infants have in common is that they must grow. A normal weight gain will be about 15-20 gram/kg per day. The best possible way to do that is by using breast feeding, however that will not always be possible. The best second option is to use human milk that is donated by other women who have more milk than they need to feed their own baby.

Human milk is collected through and in human milk banks in Europe and in hospitals. There is currently no consistent and harmonized regulation for the collection of human milk in Europe. Over the last months, a group of experts have worked together to develop recommendations how to arrive at the regulation of human milk. I was very honored to be one the participants in that expert group.

The resulting document is called “Making Human Milk Matter” and is available through the link: www.efcni.org/human-milk-regulation

November 2020

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Written by Arjan Menger on 11 September 2020. Posted in In my view.

Experiences with a KLM reservation

Recently I had made a reservation to fly from Amsterdam to Kyiv, Ukraine. When I learned that Ukraine has closed its borders for foreigners as part of their COVID-19 containment measures, I had to cancel my flight.

I went to the website, forgot and entered 3 times a wrong password. Now the system kicked me out and I had to get a new password. All my fault and I cannot complain about that.

With the mew password I entered the website and tried to cancel my flight and request a refund. That was not easy since it stated that when you cancel the flight, you cannot get a refund but get a voucher. I then decided to call KLM.

I explained that I had to cancel my reservation since I would not be allowed to enter the country. I mentioned that if I cancelled, I would not get a refund but instead receive a voucher and therefore needed assistance. The answer was shocking. Since the flight was still on the schedule as operational, KLM would not issue a refund when I cancelled. The best I could get was a voucher.

I found that appalling. I fully understand that airlines go through difficult times but when a passenger cannot take the flight because the borders of the country where they are supposed to go to, are closed because of the pandemic that we are in, then I expect more flexibility than what was shown in the call.

The website by the way also mentions that a refund can take up to 3 months before it can be refunded. In this time of automation, I also find that difficult to understand.

Come on KLM, you can do much better!